| CTRI Number |
CTRI/2025/11/097114 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A 4-week app-based posture and exercise study on the neck pain and phone use in undergraduate students |
|
Scientific Title of Study
|
Text Neck Syndrome and Postural Disorders Among Dental and Engineering Undergraduates: A Cross-sectional Study with Smartphone-Based Exercise Intervention |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yaswanth Nath Babu Yalavarthi |
| Designation |
III BDS Student |
| Affiliation |
Vishnu Dental College |
| Address |
Block 3, Ground Floor, Room no 2, PG clinic,
Vishnu Dental College, Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7207293956 |
| Fax |
|
| Email |
yaswanthnath5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Divya Naga Lakshmi |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral and Maxillofacial Surgery,
Block 3, Ground Floor, Room no 2, PG clinic,
Vishnu Dental College, Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9640185785 |
| Fax |
|
| Email |
puvvadadivya87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Divya Naga Lakshmi |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral and Maxillofacial Surgery,
Block 3, Ground Floor, Room no 2, PG clinic,
Vishnu Dental College, Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9640185785 |
| Fax |
|
| Email |
puvvadadivya87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur,
Bhimavaram-534202, West Godavari District, Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Yalavarthi Yaswanth Nath Babu |
| Address |
III BDS, Room no:2, Block 3, Ground Floor, Vishnu Dental College, Vishnupur, Bhimavaram-534202, West Godavari District, Andhra Pradesh, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Yalavarthi Yaswanth Nath Babu |
Vishnu Dental College |
Room no 2, PG Clinic, Ground Floor, Department of Oral and Maxillofacial Surgery, Vishnu Dental College, Vishnupur, Bhimavaram-534202, Andhra Pradesh, India
West Godavari
ANDHRA PRADESH |
7207293956
yaswanthnath5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neck exercise |
Participants will use a smartphone-based reminder application along with a standardized 5-minute instructional video demonstrating posture correction and neck-stretching exercises. They will perform these exercises three times daily (at 7 AM, 1 PM, and 6 PM) for a duration of four weeks. The reminder application will prompt participants to perform each session at the scheduled times. Each exercise session will last approximately five minutes, with a total daily exercise duration of about 15 minutes. Participants will record their adherence using a daily exercise log. |
| Comparator Agent |
Routine behaviour |
Participants in the comparator arm will continue their usual daily routine without the exercise video. They will receive reminder prompts only (three times daily at 7 AM, 1 PM, and 6 PM) via their smartphone reminder app for four weeks to standardise attention regarding posture. No guided exercise video will be provided. Assessments will be performed at baseline and after 4 weeks. Participants will record any activity in a daily log. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Students currently enrolled as a second to fourth year dental or engineering undergraduate.
2. Regular smartphone use for more than three hours/day (self reported average over past week)
3. Owns and is willing to use an Android or iOS smartphone and install the study app
4. Able and willing to provide written informed consent
5. To attend baseline and four week follow up (online or in person)
6. Able to understand study instructions and perform simple neck exercises/guided stretching (no cognitive impairment) will be included
|
|
| ExclusionCriteria |
| Details |
1. Students with History of neck or cervical spine surgery or major trauma
2. Current or recent (within past 3 months) physiotherapy, chiropractic treatment, or supervised neck exercise program, Known inflammatory arthropathy (e.g., rheumatoid arthritis), neuromuscular disorder, or systemic disease affecting the musculoskeletal system
4. Clinically significant cervical radiculopathy or myelopathy (red-flag neurological signs such as progressive weakness, bowel/bladder disturbance)
5. Use of medications that substantially affect muscle tone or pain perception (e.g., chronic opioids, high-dose systemic steroids)
6. Pregnancy,
7. Severe psychiatric illness or cognitive impairment limiting comprehension or consent,
8. Inability or unwillingness to install/use the study app or to complete follow-up will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Neck Disability Index scores+ |
At baseline and after four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Cornell Musculoskeletal Discomfort scores, Smartphone Addiction Scale scores, daily screen time, craniovertebral angle measurements, and adherence to the exercise program |
At baseline and after four weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Smartphones have become an essential part of student life for studying, chatting, or entertainment. But spending long hours looking down at screens can strain the neck and upper back. This problem, known as Text Neck Syndrome, happens when the head is bent forward for long periods, putting extra pressure on the spine. It can cause pain, stiffness, and bad posture if ignored. This study looks at how common neck and posture problems are among dental and engineering students. Dental students often work with their heads bent forward during clinical work, while engineering students spend long hours using computers. Both groups are at risk of developing text neck. The research will include students aged 18 to 24 from a dental college and an engineering college on the same campus. First, all participants will answer simple questionnaires about neck pain, screen use, and daily habits. Photos of their neck posture will also be taken to see how far the head bends forward. A smaller group of students will then take part in a four week program using free mobile apps that send posture reminders and teach short stretching exercises. These students will be compared with others who don’t use the app to see if it really helps reduce pain and improve posture. By the end of the study, the team hopes to find out how common text neck is among students, how it is linked to phone use, and whether simple smartphone-based exercises can make a difference. The goal is to raise awareness and encourage better habits among young people who spend long hours on screens, helping prevent long-term neck and posture problems. |