| CTRI Number |
CTRI/2024/06/068828 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of two relaxation technique relaxation on sleep quality |
|
Scientific Title of Study
|
Effect of progressive relaxation technique versus Benson relaxation on sleep quality in elderly with Insomnia: A comparative 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 |
vaishnavi bubna |
| Designation |
pg student |
| Affiliation |
Dr. D. Y. Patil college of Physiotherapy |
| Address |
Department of Community Based Rehabilitation lab, 4th floor, Dr. D.Y. Patil college of physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9730676390 |
| Fax |
|
| Email |
vbubna24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Rathi |
| Designation |
Proffesor |
| Affiliation |
Dr. D. Y. Patil college of Physiotherapy |
| Address |
Department of Community Based Rehabilitation lab, 4th floor, Dr. D.Y. Patil college of physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9850418712 |
| Fax |
|
| Email |
manisha.rathi@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
vaishnavi bubna |
| Designation |
Pg student |
| Affiliation |
Dr. D. Y. Patil college of Physiotherapy |
| Address |
Department of Community Based Rehabilitation lab, 4th floor, Dr. D.Y. Patil college of physiotherapy, Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9850418712 |
| Fax |
|
| Email |
vbubna24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaishnavi Bubna
Dr. D. Y. Patil College Of Physiotherapy, Pimpri, Pune, Maharashtra, 411018, India
|
|
|
Primary Sponsor
|
| Name |
vaishnavi bubna |
| Address |
Department of Community Based Physiotherapy, 4th floor,
Dr. D. Y.
Patil college of physiotherapy, Pimpri, Pune, Maharashtra, 411018,
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 Mayuri Shah |
Dr. D. Y. Patil college of physiotherapy |
Department of
Cardio-pulmonary lab ,
3th floor.
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8087861628
mayuri.shah@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Dr. D. Y. Patil College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Benson Relaxation Technique |
Benson Relaxation Technique, Take a seat in a restful posture. - Keep your eyes closed. Relax all muscles, starting at the feet and working up to the top of the head, and relax all regions of the body. - Take a deep breath through your nose. When exhaling, exhale from the lips, repeat one word or number (as Allah), inhale, and exhale with ease and confidence. - Try to keep their body and muscles relaxed while mentally repeating the desired word. Then slowly open your eyes and remain motionless for a few minutes. Total treatment last for 20 mins.Intervention will be given for 4 weeks consecutively, 5 days per week, two times morning and evening of which 1week supervised off line and next 3 weeks participants perform at home using video which are sent on WhatsApp group. Doubt clearing session also done on WhatsApp group . |
| Intervention |
Jacobsons relaxation technique |
Jacobsons relaxation technique is a type of therapy that involves repeatedly tightening and relaxing specific muscle regions. Its also referred to as progressive relaxation therapy. You can become more aware of your body and physical sensations by focusing on certain places and tensing and then relaxing them again.
The method consisted of tightening the following muscle groups for 5-7 seconds, followed by a 20-second relaxation period. Alternating tension and relaxation of muscles in the limbs, belly, and face. Complete treatment time is 20 mins. Intervention will be given for 4 weeks consecutively, 5 days per week, two times morning and evening of which 1week supervised off line and next 3 weeks participants perform at home using video which are sent on WhatsApp group. Doubt clearing session also done on WhatsApp groups.
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients with insomnia using insomnia severity index scale score 15 to 28 moderate or sever insomnia, Individuals with normal cognitive level using mini mental status exam score 24 0n 30
|
|
| ExclusionCriteria |
| Details |
Elderly with Migraine
Elderly who are diagnosed with psychological disorder and undertaking Psychotic Drugs.
History of Neurosurgery last (6 months)
Neurological conditions
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Insomnia Severity Index
Pittsburgh Sleep Quality Index (PSQI) |
pre value 0th week
post value at 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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 Yet Recruiting |
| 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
|
As a result of changing
times and technological breakthroughs, human health has suffered greatly. Poor sleep quality affects people of all
ages, and non-pharmacological solutions are becoming increasingly necessary.
The Relaxation Techniques are a strong challenger in the battle. However,
further research is needed before a firm conclusion can be drawn concerning its
usefulness as an intervention. There has been paucity of Research
studies which compare effect of Jacobson Progressive Relaxation Technique Versus
Benson Relaxation Technique on improving sleep quality so this study focuses on
the non-pharmacological management of the mild to moderate insomnia by using
certain relaxation techniques targeting the elderly. |