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CTRI Number  CTRI/2025/02/080582 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effectiveness of Guided Imagery and Mindfulness of Breathing in Neck pain Patients 
Scientific Title of Study   Immediate Effectiveness of Guided Imagery and Mindfulness of Breathing in Neck pain: RCT 
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 Fatimah Atharuddin Kazi 
Designation  Master of Musculoskeletal Physiotherapy Student 
Affiliation  Maharashtra Institute Of Physiotherapy Latur 
Address  Musculoskeletal OPD Maharashtra Institute of Physiotherapy MIMSR Medical Campus Ambajogai Latur Latur MAHARASHTRA 413512 India

Latur
MAHARASHTRA
413512
India 
Phone  9373265488  
Fax    
Email  fatimahkazi3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhash Khatri 
Designation  Principal and Professor of Musculoskeletal Physiotherapy 
Affiliation  Maharashtra Institute Of Physiotherapy Latur 
Address  Musculoskeletal OPD Maharashtra Institute of Physiotherapy MIMSR Medical Campus Ambajogai Latur Latur MAHARASHTRA 413512 India

Latur
MAHARASHTRA
413512
India 
Phone  8830174477  
Fax    
Email  physiokhatri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhash Khatri 
Designation  Principal and Professor of Musculoskeletal Physiotherapy 
Affiliation  Maharashtra Institute Of Physiotherapy Latur 
Address  Musculoskeletal OPD Maharashtra Institute of Physiotherapy MIMSR Medical Campus Ambajogai Latur Latur MAHARASHTRA 413512 India

Latur
MAHARASHTRA
413512
India 
Phone  8830174477  
Fax    
Email  physiokhatri@gmail.com  
 
Source of Monetary or Material Support  
Maharashtra Institute of Physiotherapy, MIMSR Medical Campus, Ambajogai road ,Latur, MAHARASHTRA PIN CODE:413512 India  
 
Primary Sponsor  
Name  Maharashtra Institute of Physiotherapy Latur 
Address  Maharashtra Institute of Physiotherapy MIMSR Medical Campus Ambajogai road Latur Latur MAHARASHTRA 413512 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Fatimah Atharuddin Kazi  Maharashtra Institute Of Physiotherapy  Department of Musculoskeletal Physiotherapy Maharashtra Institute Of Physiotherapy MIMSR Medical Campus Ambajogai road Latur MAHARASHTRA
Latur
MAHARASHTRA 		 9373265488

fatimahkazi3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maharashtra Institute Of physiotherapy, Ethical Committee Latur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M542||Cervicalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination of guided imagery technique and Mindfulness breathing technique  Group C will receive the combination of Guided imagery technique and Mindfulness of breathing technique in one session on the first day itself. Guided imagery will be given for 5 minutes and Mindfulness of breathing will be given for 5 minutes. Pre assessment scores will be taken before the therapy session and immediately after the therapy session is completed post assessment scores will be recorded. 
Intervention  Guided imagery technique  Group A will receive the Guided imagery technique in one session on the first day itself. The treatment session will be of 10 minutes. Pre assessment scores will be taken before the therapy session and immediately after the therapy session is completed post assessment scores will be recorded. 
Intervention  Mindfulness of breathing technique   Group B will receive the Mindfulness of breathing technique in one session on the first day itself. The treatment session will be of 10 minutes. Pre assessment scores will be taken before the therapy session and immediately after the therapy session is completed post assessment scores will be recorded. 
Comparator Agent  Supine lying positioning  Group D will receive the Supine lying positioning in one session on the first day itself. The treatment will be given for 10 minutes. Pre assessment scores will be taken before the therapy session and immediately after the therapy session is completed post assessment scores recorded. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Both male and female individuals with neck pain.
2. Age group between 20 to 60 years.
3. Participants with acute, subacute, and chronic neck pain.
4. Participants who report to MSK physiotherapy OPD of a tertiary hospital.
5. Individuals who are willing to participate in the research study.
6. Clearance from a healthcare professional for physiotherapy.
 
 
ExclusionCriteria 
Details  1. Participants with VBI (Vertebrobasilar insufficiency).
2. Patients with Constant neck pain
3. Participants with alar ligament insufficiency.
4. Participants supporting their chin.
5. Participants with known congenital anomalies.
6. Participants who had undergone surgery for neck pain.
7. History of HNF trauma in the last six months.
8. Participants with recent Whiplash injury.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Visual analogue scale (VAS)
2. Pain-pressure threshold (PPT)  		 Pre-treatment assessment before therapy session.
Post-treatment scores will be recorded immediately after therapy session 
 
Secondary Outcome  
Outcome  TimePoints 
1. Systolic blood pressure
2. Pulse rate
3. Respiratory rate
 		 Pre-treatment assessment before therapy session.
Post-treatment scores will be recorded immediately after therapy session 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   24/02/2025 
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="1"
Months="0"
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  

The study procedure will start after approval from the institutional ethics committee. The purpose of the study will be explained to each participant, and written informed consent will be taken. Participants will be recruited for the study on the basis of inclusion and exclusion criteria. Participants will be randomly allocated to four groups viz, guided imagery, mindfulness of breathing, a combination of these two and a control group. The intervention will be performed on the first day itself. 

Participants will receive a one-day session of guided imagery, mindfulness of breathing, a combination of both and sham relaxation for 10 minutes each in the respective groups. Allocation concealment will be maintained to reduce bias. Pre and Post outcome measures will be assessed: Visual analogue scale, Pain-Pressure threshold, Blood pressure, Heart rate and respiratory rate. Participants will then be guided to take conventional physiotherapy once the intervention is completed.

 
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