| CTRI Number |
CTRI/2024/12/077941 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Using Mobile Phones in the Toilet on Neck Pain, Posture, and Stress Levels: A Study on Adults with Chronic Neck Pain |
|
Scientific Title of Study
|
Effects of mobile device usage in the toilet on pressure pain threshold, craniovertebral angle, and stress levels among adults with Chronic Non-Specific Neck Pain: A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B 319, Department of Physiotherapy, School of Allied Health Sciences, Plot No. 2, Sector 17A, Opposite Buddha International Circuit
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B 319, Department of Physiotherapy, School of Allied Health Sciences, Plot No. 2, Sector 17A, Opposite Buddha International Circuit
UTTAR PRADESH
203201
India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDr Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No. B316, Department of Physiotherapy, School of Allied Health Sciences, Plot No. 2, Sector 17A, Opposite Buddha International Circuit
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
97117774174 |
| Fax |
|
| Email |
drakshchahal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development cell Galgotias University
Room No C110, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India, 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, India, 203201 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammad Sidiq |
Galgotias University |
Room No: E003, Sector 2, Sector 17A, Opposite
Buddha International
circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
6006204628
sidufatima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Neck Pain: Individuals diagnosed with chronic non-specific neck pain (lasting more than 12 weeks).
2. Mobile Usage: Regular mobile phone users (spending at least 5 hours daily on mobile devices).
3. Toilet Usage: Habitual use of mobile devices during toilet visits (at least 3 times a week).
4. Willingness to Participate: Individuals providing informed consent to participate in the study.
5. Physical Activity Level: Sedentary to moderately active individuals (assessed via validated physical activity questionnaires).
|
|
| ExclusionCriteria |
| Details |
1. Specific Neck Conditions: Participants with specific neck pain causes (e.g., trauma, fractures, tumors, or infections).
2. Comorbidities: Individuals with systemic illnesses (e.g., diabetes, hypertension, or rheumatoid arthritis) or neurological conditions affecting posture or pain perception.
3. Surgical History: Previous neck or spinal surgery.
4. Recent Therapies: Participants undergoing physiotherapy, chiropractic treatment, or pain-relief medications in the past 6 weeks.
5. Pregnancy: Pregnant women (to avoid confounding factors related to posture and stress).
6. Non-Compliant Mobile Usage: Individuals who do not habitually use mobile devices in the toilet.
7. Psychological Disorders: Diagnosed cases of anxiety, depression, or other psychiatric illnesses that could influence stress levels.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pressure Pain Threshold by Algometer
Craniovertebral angle by APECS software
Perceived Stress Scale |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mobile usage questionnaire |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="157"
Sample Size from India="157"
Final Enrollment numbers achieved (Total)= "287"
Final Enrollment numbers achieved (India)="287" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/12/2024 |
| Date of Study Completion (India) |
24/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sidufatima@gmail.com].
- For how long will this data be available start date provided 01-06-2025 and end date provided 11-07-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - na
|
|
Brief Summary
|
This study investigates the impact of mobile device usage in toilets on neck pain, posture, and stress levels in adults with chronic non-specific neck pain (CNNP). It examines changes in pressure pain threshold, craniovertebral angle, and stress among habitual mobile users. Adults aged 18–60 years with CNNP and regular mobile usage in toilets are included, while those with specific neck conditions, systemic illnesses, or recent therapies are excluded. The study minimizes confounding factors by focusing on sedentary to moderately active individuals. Data collection involves pain threshold measurement, posture analysis, and validated stress scales. The study aims to identify whether prolonged mobile use during toilet visits contributes to worsening neck pain and poor posture, offering insights into lifestyle habits that may exacerbate CNNP. Findings can guide physiotherapists and health professionals in developing preventive strategies and ergonomic recommendations for reducing pain and improving overall neck health. |