This is my thesis give me proper reference including the doin and give sample size dot the questionnaire based study and statistical analyses
cd /home/daytona/workspace/attachments/73da90cf-c6d5-4c6c-93ac-d1a425c17025/ && …
NiTi archwire orthodontic pain perception
orthodontic pain adults adolescents age comparison
orthodontic pain numerical rating scale questionnaire
PMID: 1927986
PMID: 26516711
PMID: 34488744
PMID: 34731504
orthodontic pain sex differences gender fixed appliances
PMID: 14994886
PMID: 8921656
orthodontic pain periodontal ligament prostaglandins inflammatory mediators
ibuprofen analgesics orthodontic tooth movement NSAIDs
Olteanu 2022 Applied Sciences orthodontic pain fixed appliances DOI 10.3390/app12136389
PMID: 28876390
https://pmc.ncbi.nlm.nih.gov/articles/PMC11989609
orthodontic pain review management fixed appliances
PMID: 38319008
n per group = 2 × (Z_α/2 + Z_β)² × σ² / d²
| Parameter | Value | Justification |
|---|---|---|
| Z_α/2 | 1.96 | Two-tailed α = 0.05 |
| Z_β | 0.84 | Power = 80% |
| σ (SD of NRS) | 1.8 points | Drawn from Scheurer et al. 1996 [Ref 5] and Fernandes et al. 1998 [Ref 6], where NRS/VAS SDs in comparable archwire-pain studies typically range 1.6-2.0 |
| d (min detectable difference) | 1.0 point | Widely accepted MCID for 0-10 pain scales in orthodontic research |
| Analysis | Questionnaire Variable | Test | Correction / Notes |
|---|---|---|---|
| Primary: Pain intensity (Section B, Q2: NRS 0-10) at each of 4 timepoints | Continuous NRS scores | Independent t-test (if normal) or Mann-Whitney U (if non-normal) | Bonferroni α = 0.05/4 = 0.0125 per timepoint; report Cohen's d |
| Primary: Pain trajectory (NRS at all 4 timepoints combined) | Repeated NRS scores over time | Mixed-design (split-plot) repeated-measures ANOVA: Group (adolescent/adult) × Time (6h/24h/7d/14d) | Check Mauchly's sphericity → Greenhouse-Geisser if violated; report η²_p; or use linear mixed-effects model (LME) if attrition >10% |
| Secondary: Analgesic use (Section B, Q6: Yes/No) | Dichotomous | Chi-square (or Fisher's exact if expected cell < 5) | Report OR + 95% CI per group |
| Secondary: Medication type (Section B, Q7) | Categorical (4 options) | Chi-square for proportions across groups | Report % per category |
| Secondary: Peak pain timepoint (Section C, Q1) | Categorical (4 timepoints) | Chi-square goodness-of-fit or frequency comparison | Report modal timepoint per group |
| Secondary: Functional impact (Section B, Q3-Q5: eating/sleep/speech) | Ordinal (None/Mild/Mod/Severe) | Mann-Whitney U or Chi-square (collapsed to affected/not affected) | Separate analysis for each domain |
| Exploratory: Sex × Group interaction | Group + Sex (Section A, Q3) | Three-way mixed ANOVA (Group × Sex × Time) or stratified two-way ANOVA per sex | Exploratory; do not apply Bonferroni here - report as hypothesis-generating |
| Normality testing (pre-analysis) | NRS scores at each timepoint | Shapiro-Wilk + Q-Q plot inspection | If n > 50 per group and distribution is near-normal, t-test is robust by CLT regardless |
| Effect size reporting | All primary tests | Cohen's d (t-tests), partial η² (ANOVA), OR + 95%CI (categorical) | Mandatory alongside p-values |
lme4, rstatix, car, emmeans), Python (pingouin, statsmodels), or GNU PSPP (used in parent study). G*Power for a priori power analysis.Give the reference in a proper style for a institute review board submission in a pdf format
mkdir -p /home/daytona/workspace/irb-references && python3 -c " from reportlab.l…
ls -lh /home/daytona/workspace/irb-references/
IRB References Vancouver
PDF Document · PDF
| Section | References |
|---|---|
| 1. Parent Study & Core Framework | Refs 1-2 (Olteanu 2022; Raja/IASP 2020) |
| 2. Mechanisms & Reviews | Refs 3-5 (Krishnan 2007; Bergius 2000; Cochrane 2024) |
| 3. NiTi Archwire Pain Studies | Refs 6-10 (Scheurer 1996; Fernandes 1998; Erdınç 2004; Abdelrahman 2015; Azizi 2021) |
| 4. Age & Sex Differences | Refs 11-13 (Brown 1991; Salgado 2022; Nandi 2019) |
| 5. Analgesic Use | Refs 14-15 (Arias 2006; Corrêa 2017) |
| 6. Unverified DOI (flagged in red) | Ref 16 (Bud 2021 - verify before submission) |
Create a full IRB-ready research protocol document combining this reference list, sample size table, and statistical analysis plan
mkdir -p /home/daytona/workspace/irb-protocol && python3 << 'PYEOF' from reportl…
Create a full IRB-ready research protocol document combining this reference list, sample size table, and statistical analysis plan
mkdir -p /home/daytona/workspace/irb-protocol && python3 << 'PYEOF' from reportl…
ls -lh /home/daytona/workspace/irb-protocol/
IRB Research Protocol NiTi Pain
PDF Document · PDF
| Section | Content |
|---|---|
| Cover Page | Dark navy banner with full title, meta-table (PI, supervisor, target n, ethics framework, version), and confidentiality notice |
| Table of Contents | All 14 sections + Appendix A listed |
| 1. Background | Clinical context, age-pain evidence gap, parent study rationale — with in-text citations |
| 2. Aim & Objectives | Highlighted aim box + 3 primary and 2 secondary objectives as bullets |
| 3. Study Hypotheses | Table: H1 (pain intensity), H2 (peak timepoint), H3 (analgesic use) — null and alternative for each |
| 4. Study Design | Clean parameter table (design type, groups, exposure, outcome, timepoints) |
| 5. Setting & Ethics | Setting placeholder, ethical approval requirements, consent procedures (adults vs minors) |
| 6. Eligibility Criteria | Side-by-side green/red inclusion and exclusion tables; group definition table with target n |
| 7. Sample Size | Formula box, parameter table with sources, worked calculation box (51→128 with 20% attrition), attrition scenario table, repeated-measures power note |
| 8. Clinical Procedure | Wire standardisation requirements and covariate recording guidance |
| 9. Outcome Measures | Primary outcome description + full secondary outcomes table mapped to questionnaire items |
| 10. Data Collection | Timeline table (T0–T4), delivery method, missing data guidance |
| 11. Statistical Analysis Plan | Full analysis table with dark-navy sub-headers for primary/secondary/exploratory groups; effect size reporting table; significance thresholds; software list |
| 12. Ethical Considerations | 7-point bullet list (voluntariness, pseudonymisation, assent, storage, risk, Helsinki, GDPR) |
| 13. Limitations | 6 limitations with citations |
| 14. References | 16 references in 6 coloured sub-sections (A–F); all with confirmed DOIs; Ref 16 flagged in red with warning |
| Appendix A | Full questionnaire — Section A (baseline), Section B (×4 timepoints), Section C (14-day only) — with signature block |
I need you to fill in this type of format edit and give me
cd /home/daytona/workspace && pandoc --track-changes=all "/home/daytona/workspac…
ls /home/daytona/workspace/attachments/73da90cf-c6d5-4c6c-93ac-d1a425c17025/ && …
cp "/home/daytona/workspace/attachments/73da90cf-c6d5-4c6c-93ac-d1a425c17025/LIY…
wc -l /home/daytona/workspace/irb-protocol/liya_unpacked/word/document.xml && he…
python3 << 'PYEOF' import re with open('/home/daytona/workspace/irb-protocol/li…
python3 << 'PYEOF' import re, shutil with open('/home/daytona/workspace/irb-pro…
cd /home/daytona/workspace/irb-protocol/liya_unpacked && zip -r ../NiTi_Pain_IRB…
cd /home/daytona/workspace/irb-protocol && python3 -c " import zipfile, os out =…
cd /home/daytona/workspace/irb-protocol && python3 -c " import zipfile, os, io …
cd /home/daytona/workspace/irb-protocol && python3 /home/daytona/skills/docx/scr…
cd /home/daytona/workspace/irb-protocol && pandoc NiTi_Pain_IRB_PROPOSAL.docx -t…
python3 -c "import docx; print('ok')"
pip install python-docx --quiet 2>&1 | tail -3
python3 << 'PYEOF' from docx import Document from docx.oxml.ns import qn from do…
python3 << 'PYEOF' from docx import Document from docx.oxml.ns import qn from do…
Give
python3 << 'PYEOF' from docx import Document from docx.oxml.ns import qn from do…
pip install python-docx --quiet --user 2>&1 | tail -2 && python3 -c "from docx i…
~/irb-protocol/fill_irb.py
from docx import Document
from docx.oxml.ns import qn
from docx.oxml import OxmlElement
import io, os, sys
src = "/home/daytona/workspace/attachments/73da90cf-c6d5-4c6c-93ac-d1a425c17025/LIYA IRB PROPOSAL.docx"
doc = Document(src)
tables = doc.tables
def cw(cell, lines):
"""Clear cell and write list of (text, bold) tuples as paragraphs."""
tc = cell._tc
for p in tc.findall(qn('w:p')):
tc.remove(p)
for text, bold in lines:
p = OxmlElement('w:p')
r = OxmlElement('w:r')
rpr = OxmlElement('w:rPr')
sz = OxmlElement('w:sz'); sz.set(qn('w:val'), '20'); rpr.append(sz)
szcs = OxmlElement('w:szCs'); szcs.set(qn('w:val'), '20'); rpr.append(szcs)
if bold:
b = OxmlElement('w:b'); rpr.append(b)
r.append(rpr)
t = OxmlElement('w:t'); t.text = text
if text and (text[0] == ' ' or text[-1] == ' '):
t.set('{http://www.w3.org/XML/1998/namespace}space', 'preserve')
r.append(t); p.append(r); tc.append(p)
T = tables
# 1 — Candidate
cw(T[0].rows[0].cells[1],[
('Name of the candidate: [Your Name]',False),('',False),
('Phone No: [Your Phone No]',False),('',False),
('Email ID: [Your Email]',False),
])
# 4 — Final exam
cw(T[0].rows[3].cells[1],[('Month and year of appearing for the final examination: November 2026',False)])
# 10 — Title
cw(T[1].rows[2].cells[1],[
('Title Of Dissertation:',True),('',False),
('A Comparative Study of Pain Perception in Adults and Adolescents Following Placement of Initial NiTi Archwires in Orthodontic Treatment',False),
])
# 11 — Introduction
cw(T[1].rows[3].cells[1],[
('Introduction:',True),('',False),
('Pain and masticatory discomfort are among the most frequently reported adverse effects of fixed orthodontic treatment and remain a leading cause of reduced patient compliance and, in some cases, discontinuation of treatment. Orthodontic tooth movement triggers an inflammatory response within the periodontal ligament (PDL) and pulp, releasing biochemical mediators - prostaglandins, cytokines, and substance P - that underlie the sensation of pain associated with appliance activation. [1,2,3]',False),('',False),
('The initial aligning phase typically employs superelastic nickel-titanium (NiTi) archwires, valued for delivering continuous light forces. A 2024 Cochrane meta-analysis (29 RCTs, 1915 participants) found low-certainty evidence of little difference in pain between NiTi wire types, confirming that the inflammatory response - rather than the wire alloy - is the primary pain driver. [4,5]',False),('',False),
('Age is one of the most frequently cited yet inconsistently reported variables in orthodontic pain research. Some studies report adults perceive greater pain than adolescents (attributed to denser alveolar bone and reduced PDL turnover); others report no difference, attributing apparent differences to psychological factors and coping strategies. This inconsistency is the central gap this study addresses. [6,7,8]',False),('',False),
('The parent study (Olteanu et al., 2022) evaluated pain across four orthodontic procedures in 100 patients across four age bands using a single-timepoint retrospective questionnaire. The present study narrows focus to a single clinical event - placement of the first NiTi aligning archwire - and captures pain prospectively at four fixed timepoints: 6 hours, 24 hours, 7 days, and 14 days post-placement. [1]',False),
])
# 12 — Aims
cw(T[2].rows[0].cells[1],[
('Aims & Objectives:',True),('',False),
('AIM:',True),('',False),
('To compare pain intensity, onset, duration, and medication requirements following placement of the initial NiTi aligning archwire between adolescent (12-18 years) and adult (>=19 years) orthodontic patients, assessed prospectively at 6 hours, 24 hours, 7 days, and 14 days post-placement.',False),('',False),
('OBJECTIVES:',True),('',False),
('Primary Objective',True),
('To measure and compare mean pain intensity (NRS 0-10) between adolescents and adults at 6 hours, 24 hours, 7 days, and 14 days after initial NiTi archwire placement.',False),('',False),
('Secondary Objectives',True),
('1. To identify the timepoint of peak pain intensity in each age group.',False),
('2. To compare the proportion requiring analgesic medication and type of medication used between groups.',False),
('3. To evaluate the impact of pain on daily function (eating, sleeping, speaking) between groups.',False),
('4. To assess whether sex modifies the pain response between the two age groups (exploratory).',False),
])
# 13 — Literature
cw(T[2].rows[1].cells[1],[
('1) Relevant review of literature (maximum 5-6 reviews):',True),('',False),
('1. Olteanu et al. (2022)',True),
('Conducted a questionnaire-based study on pain perception during fixed orthodontic treatment in 100 patients across four age bands using a Numerical Rating Scale. Found arch activation was the second most painful procedure; pain peaked during the first 3-4 days. Sex-based differences were significant (ANOVA F=33.6, p<0.01). This study served as the design template for the present protocol, which extends it to a prospective four-timepoint design focused on the first NiTi archwire.',False),('',False),
('2. Scheurer et al. (1996)',True),
('Investigated pain in 170 patients (age 8-53 years) using eight daily questionnaires. Found 95% reported pain at 24 hours; the 13-16-year age group had the highest pain frequency; pain intensity did not differ significantly across age groups; girls reported higher pain than boys. Provided the SD estimate (sigma=1.8 points) used in the present sample size calculation.',False),('',False),
('3. Abdelrahman et al. (2015)',True),
('Prospective clinical trial comparing pain with three NiTi archwire types in 75 patients. No significant differences in pain intensity among wire types (p=0.63). Gender, age, and crowding had no significant effect on perceived discomfort - key evidence supporting the age-group comparison in this study.',False),('',False),
('4. Brown and Moerenhout (1991)',True),
('Longitudinal study comparing pain experience among preadolescents (11-13y), adolescents (14-17y), and adults (>=18y) during fixed appliance treatment. Adolescents reported significantly higher pain and lower psychological well-being than both preadolescents and adults, suggesting adolescents are more vulnerable to adverse effects of orthodontic pain. Directly supports the age-group comparison rationale.',False),('',False),
('5. Erdinc and Dincer (2004)',True),
('Investigated pain following placement of 0.014-inch and 0.016-inch archwires in 109 adolescent patients over 7 days. Initial pain perceived at ~2 hours, peaked at 24 hours, decreased significantly by day 3. No significant difference between wire sizes or genders. Provided direct evidence for the four timepoints used in this study.',False),('',False),
('6. Salgado et al. (2022)',True),
('Cohort study of 44 patients assessing pain at baseline, 6h, 24h, 2nd, 3rd, 5th, and 7th day after activation. Pain peaked at 24 hours. Pain catastrophising showed a weak but significant association with pain at the first appointment. Older patients had a weak protective association with pain.',False),
])
# 14 — Research question & hypothesis
cw(T[2].rows[2].cells[1],[
('RESEARCH QUESTION:',True),('',False),
('Does placement of the initial superelastic NiTi aligning archwire result in significantly different pain intensity, onset, duration, and medication requirements between adolescent (12-18 years) and adult (>=19 years) orthodontic patients when assessed prospectively at 6 hours, 24 hours, 7 days, and 14 days?',False),('',False),
('RESEARCH HYPOTHESIS:',True),('',False),
('Null Hypothesis (H0):',True),
('There is no statistically significant difference in mean pain intensity (NRS 0-10) between adolescent and adult patients at any of the four timepoints following initial NiTi archwire placement. There is no significant difference in analgesic use, peak pain timepoint, or functional impact between the two groups.',False),('',False),
('Alternative Hypothesis (H1):',True),
('There is a statistically significant difference in mean pain intensity (NRS 0-10) between adolescent and adult patients at one or more of the four timepoints following initial NiTi archwire placement, and/or a significant difference in analgesic use or functional impact between the two groups.',False),
])
# 15 — Methodology
cw(T[3].rows[0].cells[1],[
('Methodology (Flow chart): MATERIALS AND METHODOLOGY (FLOW CHART)',True),('',False),
('Patient recruitment (Adolescent: 12-18 years; Adult: >=19 years)',False),('',False),
('Informed consent obtained (adult: written consent; adolescent 12-17y: parental consent + assent)',False),('',False),
('Baseline assessment T0 at wire placement: Section A questionnaire (demographics, health status, wire dimension)',False),('',False),
('Initial superelastic NiTi archwire placement (standardised dimension; bracket type and ligation method recorded)',False),('',False),
('Pain questionnaire (Section B: NRS 0-10 + functional impact + analgesic use) at:',False),
(' T1: 6 hours post-placement',False),
(' T2: 24 hours post-placement',False),
(' T3: 7 days post-placement',False),
(' T4: 14 days post-placement + Section C (retrospective peak-pain timepoint)',False),('',False),
('Data entry and validation (Microsoft Excel; pseudonymisation applied)',False),('',False),
('Statistical Analysis',False),
(' Primary: Independent t-test / Mann-Whitney U at each timepoint (Bonferroni alpha=0.0125)',False),
(' Design-level: Two-way mixed repeated-measures ANOVA (Group x Time interaction)',False),
(' Secondary: Chi-square / Fisher exact for analgesic use, medication type, peak timepoint',False),
(' Exploratory: Three-way ANOVA (Group x Sex x Time)',False),('',False),
('RESULTS',False),('',False),
('CONCLUSION',False),
])
# 16 — Study parameters
cw(T[4].rows[0].cells[1],[
('Study parameters (outcome measures) being monitored:',True),
('Primary: Mean pain intensity (NRS 0-10) between adolescent and adult groups at 6h, 24h, 7d, 14d post-archwire placement.',False),
('Secondary: Analgesic use (proportion and type); peak pain timepoint; functional impact on eating, sleep, and speech; sex-based modification of pain response.',False),
])
# 18 — Type of study
cw(T[4].rows[2].cells[1],[('Type of study: Prospective, observational, questionnaire-based comparative study',False)])
# 19 — Groups
cw(T[4].rows[3].cells[1],[
('Number of groups to be studied: 2',False),
('Group 1 - Adolescent: 12-18 years',False),
('Group 2 - Adult: >=19 years',False),
('Non-randomised comparative study; groups defined by patient age at enrolment (no randomisation applied).',False),
])
# 20 — Sample size
cw(T[4].rows[4].cells[1],[
('Sample size:',True),('',False),
('Based on comparable archwire-pain literature (Scheurer et al. 1996; Fernandes et al. 1998), SD of NRS pain scores sigma = 1.8 points (0-10 scale). Using minimum clinically important difference d = 1.0 point, alpha = 0.05 (two-tailed), power = 80%:',False),('',False),
('Formula: N = 2 x (Zalpha/2 + Zbeta)^2 x sigma^2 / d^2',True),('',False),
('Z = 1.96, sigma = 1.8, E = 1.0',False),('',False),
('N = 2 x (1.96 + 0.84)^2 x 1.8^2 / 1.0^2',False),
('N = 2 x (2.80)^2 x 3.24 = 2 x 7.84 x 3.24 = 50.8',False),
('N = 51 participants per group (minimum)',False),('',False),
('Adjusting for 20% anticipated attrition across four follow-up timepoints:',False),
('n per group = 51 / 0.80 = 64',False),
('TOTAL RECRUITMENT TARGET = 128 participants (64 per group)',True),
])
# 21 — Inclusion
cw(T[5].rows[0].cells[1],[
('Inclusion criteria:',True),
('1. Patients beginning fixed orthodontic treatment receiving their first NiTi aligning archwire.',False),
('2. Age 12 years and above.',False),
('3. Good general health; no active orofacial pain unrelated to orthodontic treatment.',False),
('4. Willingness and ability to complete a self-report questionnaire at each timepoint.',False),
('5. Available for follow-up at all four timepoints (6h, 24h, 7 days, 14 days).',False),
('6. Adolescent group: 12-18 years. Adult group: 19 years and above.',False),
])
# 22 — Exclusion
cw(T[5].rows[1].cells[1],[
('Exclusion criteria:',True),
('1. Patients taking regular analgesic or anti-inflammatory medication for an unrelated chronic condition.',False),
('2. Craniofacial syndromes, active TMJ disorders, or recent oral/maxillofacial surgery.',False),
('3. Known allergy to nickel or titanium.',False),
('4. Inability to complete the questionnaire independently or via guardian-assisted administration.',False),
('5. Previous fixed orthodontic treatment within the past 12 months.',False),
])
# 25 — Statistical analysis
cw(T[5].rows[4].cells[1],[
('Methods of statistical analysis',True),('',False),
('Data Management:',True),
('Collected data will be entered and compiled using Microsoft Excel 2019. Data will be analysed using Statistical software SPSS version 23.0 (or R).',False),('',False),
('Statistical Analysis:',True),
('Categorical data expressed as frequency and percentage. Continuous variables expressed as mean +/- SD (if normally distributed) or median (IQR) if non-normal. Normality assessed by Shapiro-Wilk test and Q-Q plot inspection.',False),('',False),
])
# Also write the objectives-table rows inside item 25
# (The inner table in item 25 is a separate table object)
# Find the inner stats table - it is tables[5] rows[4] but inner tables are separate
# Instead write all stats in the text above. Add more lines:
# Re-open and append to item 25 cell
cell25 = T[5].rows[4].cells[1]
tc25 = cell25._tc
def add_para(tc, text, bold=False):
p = OxmlElement('w:p')
r = OxmlElement('w:r')
rpr = OxmlElement('w:rPr')
sz = OxmlElement('w:sz'); sz.set(qn('w:val'), '20'); rpr.append(sz)
szcs = OxmlElement('w:szCs'); szcs.set(qn('w:val'), '20'); rpr.append(szcs)
if bold:
b = OxmlElement('w:b'); rpr.append(b)
r.append(rpr)
t = OxmlElement('w:t'); t.text = text
if text and (text[0]==' ' or text[-1]==' '):
t.set('{http://www.w3.org/XML/1998/namespace}space','preserve')
r.append(t); p.append(r); tc.append(p)
extra_lines = [
('Objectives and Statistical Tests:',True),('',False),
('PRIMARY OBJECTIVE - To measure and compare mean NRS pain scores between groups at each timepoint',True),
('Statistical Test: Independent-samples t-test (if normally distributed) or Mann-Whitney U test (if non-normal).',False),
('Bonferroni correction applied: adjusted alpha = 0.05/4 = 0.0125 per timepoint comparison. Report Cohen\'s d.',False),
('Design-level: Two-way mixed-design repeated-measures ANOVA (Group x Time interaction). Mauchly\'s sphericity test; Greenhouse-Geisser correction if violated. Report partial eta-squared (eta2p). Use linear mixed-effects model (LME) if attrition >10%.',False),('',False),
('SECONDARY OBJECTIVES',True),
('Analgesic use (Yes/No): Chi-square or Fisher\'s exact; OR + 95% CI per group per timepoint.',False),
('Medication type: Chi-square for proportions; % per category per group.',False),
('Peak pain timepoint: Chi-square or frequency comparison; modal timepoint per group.',False),
('Functional impact (eating/sleep/speech): Mann-Whitney U or Chi-square; separate per domain.',False),
('Sex x Group (exploratory): Three-way mixed ANOVA (Group x Sex x Time); hypothesis-generating.',False),('',False),
('Level of Significance:',True),
('P < 0.05 considered statistically significant. Bonferroni-adjusted alpha = 0.0125 for four individual timepoint comparisons. Effect sizes (Cohen\'s d, partial eta-squared, OR + 95% CI) reported alongside all p-values.',False),
]
for text, bold in extra_lines:
add_para(tc25, text, bold)
# 26 — References
cw(T[6].rows[0].cells[1],[
('References (maximum 5-10, Vancouver style):',True),('',False),
('1. Olteanu CD, Bucur S-M, Chibelean M, Bud ES, Pacurar M, Festila DG. Pain Perception during Orthodontic Treatment with Fixed Appliances. Appl Sci. 2022;12(13):6389. https://doi.org/10.3390/app12136389',False),('',False),
('2. Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, et al. The revised IASP definition of pain. Pain. 2020;161(9):1976-1982. https://doi.org/10.1097/j.pain.0000000000001939',False),('',False),
('3. Krishnan V. Orthodontic pain: from causes to management - a review. Eur J Orthod. 2007;29(2):170-179. https://doi.org/10.1093/ejo/cjl081',False),('',False),
('4. Scheurer PA, Firestone AR, Burgin WB. Perception of pain as a result of orthodontic treatment with fixed appliances. Eur J Orthod. 1996;18(4):349-357. https://doi.org/10.1093/ejo/18.4.349',False),('',False),
('5. Fernandes LM, Ogaard B, Skoglund L. Pain and discomfort experienced after placement of a conventional or a superelastic NiTi aligning archwire. J Orofac Orthop. 1998;59(6):331-339. https://doi.org/10.1007/BF01299769',False),('',False),
('6. Erdinc AM, Dincer B. Perception of pain during orthodontic treatment with fixed appliances. Eur J Orthod. 2004;26(1):79-85. https://doi.org/10.1093/ejo/26.1.79',False),('',False),
('7. Abdelrahman RSh, Al-Nimri KS, Al Maaitah EF. Pain experience during initial alignment with three types of NiTi archwires: a prospective clinical trial. Angle Orthod. 2015;85(6):1070-1076. https://doi.org/10.2319/071614-498.1',False),('',False),
('8. Brown DF, Moerenhout RG. The pain experience and psychological adjustment to orthodontic treatment of preadolescents, adolescents, and adults. Am J Orthod Dentofac Orthop. 1991;100(4):349-356. https://doi.org/10.1016/0889-5406(91)70073-6',False),('',False),
('9. Arias OR, Marquez-Orozco MC. Aspirin, acetaminophen, and ibuprofen: their effects on orthodontic tooth movement. Am J Orthod Dentofac Orthop. 2006;130(3):364-370. https://doi.org/10.1016/j.ajodo.2004.12.027',False),('',False),
('10. Salgado KR, Normando D, Brandao GAM. Is catastrophising associated with pain perception in early phase of orthodontic treatment? A cohort study. J Oral Rehabil. 2022;49(3):309-315. https://doi.org/10.1111/joor.13279',False),
])
# 27 — Preliminary work
cw(T[7].rows[0].cells[1],[
('Preliminary work done already, if any (preparation of Questionnaire, collection of patient details...):',True),('',False),
('The study questionnaire instrument has been designed and adapted from the parent study format (Olteanu et al., 2022): a baseline Section A (demographics, health status, wire dimension), a repeated Section B (NRS 0-10 pain scale, functional impact, analgesic use) administered at each of four timepoints, and a final retrospective Section C at 14 days. The relevant literature has been systematically reviewed. Ethical approval application is pending submission.',False),
])
# 28 — Ethical issues
cw(T[7].rows[1].cells[1],[
('Ethical issues involved in the study',True),
('Clinical examination, blood sampling, subjecting the patient for some investigations or procedures, asking them to come for review (to hospital) periodically, trying a new drug, utilizing the details of the disease & investigations of the patient...:',False),('',False),
('Minimal Risk. Written informed consent will be obtained from all adult participants (>=18 years). For adolescent participants (12-17 years), written parental/guardian consent and participant assent will be obtained. The study involves non-invasive procedures - self-report pain questionnaires at four timepoints following routine orthodontic archwire placement. No additional clinical procedures are required beyond standard orthodontic care. Patient data will be pseudonymised at the point of data entry. The study will comply with the Declaration of Helsinki (2013 revision).',False),
])
# 29 — Consent
cw(T[7].rows[2].cells[1],[
('Procedure involved for obtaining informed consent from the patient or Guardian & assent from the children:',True),('',False),
('Recruited patients will be informed about the purpose, procedures, voluntary nature, and confidentiality of the study. Written informed consent will be obtained from adult participants (>=18 years) prior to enrolment. For adolescent participants (12-17 years), written parental/guardian consent will be obtained along with written assent from the adolescent. Participation is entirely voluntary and withdrawal at any stage will not affect standard clinical care. Participant information will be kept strictly confidential.',False),
])
# 30 — Recruiting
cw(T[7].rows[3].cells[1],[
('Procedure involved for recruiting volunteers:',True),('',False),
('Patients beginning fixed orthodontic treatment at Sri Venkateshwaraa Dental College, Puducherry will be assessed for eligibility against the inclusion and exclusion criteria. Eligible patients will be approached by the principal investigator, informed about the study, and invited to participate. Written consent/assent will be obtained prior to enrolment. Recruitment will continue over 6-12 months until the target sample (128 participants; 64 per group) is achieved.',False),
])
# 34 — Financial frame
cw(T[7].rows[7].cells[1],[
('Financial frame: Rs. 3000 - Rs. 5000',False),
('(Printing of consent forms, assent forms, and questionnaire proformas; data entry and statistical analysis; miscellaneous stationery)',False),
])
# Save via BytesIO to avoid filesystem seek bug
buf = io.BytesIO()
doc.save(buf)
data = buf.getvalue()
out = '/home/daytona/workspace/irb-protocol/NiTi_Pain_IRB_PROPOSAL.docx'
with open(out, 'wb') as f:
f.write(data)
print("SAVED OK:", out)
print("SIZE:", os.path.getsize(out), "bytes")
cd /home/daytona/workspace/irb-protocol && python3 fill_irb.py
python3 -c " from docx import Document doc = Document('/home/daytona/workspace/i…
NiTi Pain IRB PROPOSAL
Word Document · DOCX
| Field | Content |
|---|---|
| Candidate info | Name / Phone / Email placeholders |
| Final exam | November 2026 |
| Title | Full study title |
| Introduction | 4-paragraph intro (pain mechanism, NiTi rationale, age-gap gap, parent study) |
| Aims & Objectives | 1 primary aim + 4 secondary objectives |
| Literature Review | 6 studies: Olteanu 2022, Scheurer 1996, Abdelrahman 2015, Brown 1991, Erdinc 2004, Salgado 2022 |
| Research Question + Hypotheses | H0 + H1 clearly stated |
| Methodology Flowchart | Step-by-step T0→T1→T2→T3→T4 flow with analysis plan |
| Study Parameters | Primary NRS + secondary outcomes |
| Study Type | Prospective, observational, questionnaire-based comparative |
| Groups | 2 groups (Adolescent 12-18y / Adult ≥19y) |
| Sample Size | Full formula, N=51→64 per group, 128 total with 20% attrition |
| Inclusion Criteria | 6 items |
| Exclusion Criteria | 5 items |
| Statistical Analysis | Data management + all objectives with tests, Bonferroni α=0.0125, effect sizes |
| References | 10 Vancouver-style refs with DOIs |
| Preliminary Work | Questionnaire design + literature review completed |
| Ethical Issues | Minimal risk, pseudonymisation, Declaration of Helsinki |
| Consent Procedure | Adult consent + adolescent assent procedure |
| Recruitment | Sri Venkateshwaraa Dental College, Puducherry; 6-12 months |
| Financial Frame | Rs. 3000-5000 (printing, data entry, stats) |
[Your Name], [Your Phone No], [Your Email] in the first cell with your actual detailsGive me
Same way edit this and give my name is Nevatha B Guide name Dr . Hareharasudhan
cd /home/daytona/workspace && python -m markitdown "/home/daytona/workspace/atta…
SKILL=/home/daytona/skills/pptx SRC="/home/daytona/workspace/attachments/73da90c…
mkdir -p /home/daytona/workspace/irb-ppt/unpacked cd /home/daytona/workspace/irb…
ls -lh "/home/daytona/workspace/attachments/73da90cf-c6d5-4c6c-93ac-d1a425c17025…
mkdir -p /home/daytona/workspace/irb-ppt/unpacked unzip "/home/daytona/workspace…
python3 -c " import shutil, os src = '/home/daytona/workspace/attachments/73da90…
mkdir -p /tmp/liya_unpacked unzip -o /tmp/liya_irb.pptx -d /tmp/liya_unpacked/ 2…
python3 << 'EOF' import os, re, xml.etree.ElementTree as ET NS = {'a': 'http://…
python3 << 'PYEOF' import zipfile, shutil, os, re, copy from lxml import etree …
python3 << 'PYEOF' # Check exact text of the unmatched slides import zipfile fro…
python3 << 'PYEOF' import zipfile, io, os, copy from lxml import etree SRC = '/…
python3 << 'PYEOF' # Fix the one unmatched paragraph and verify all key replacem…