| CTRI Number |
CTRI/2023/08/056914 [Registered on: 25/08/2023] Trial Registered Prospectively |
| Last Modified On: |
24/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Relaxation Exercise on Post Operative Pain,Activity Tolerance,Sleep Quality and Vital Signs in patients undergoing Abdominal Surgery:A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of Progressive Muscle Relaxation Exercise on Post Operative Pain,Activity Tolerance,Sleep Quality and Vital Signs in patients undergoing Abdominal Surgery:A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M.J Kumari |
| Designation |
Professor cum Principal(Ag) |
| Affiliation |
College of Nursing,Jawaharlal Institute of Post Graduate Medical Education and Research,Pondicherry. |
| Address |
College of Nursing,Jawaharlal Institute of Postgraduate Medical Education and Research.
Gorimedu
Dhanvantri Nagar
Pondicherry
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M.J Kumari |
| Designation |
Professor cum Principal(Ag) |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research.,Pondicherry |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research.
Medical surgical Nursing,College of Nursing,JIPMER,Puducherry-605006
Gorimedu
Dhanvantri Nagar
Pondicherry
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shabnam Kausar |
| Designation |
Student |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research.,Pondicherry |
| Address |
Room no:305
Nightingale Hostel,Jawaharlal Institute of Post Graduate Medical Education and Research Campus
Gorimedu
Dhanvantri Nagar
Pondicherry
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8402017104 |
| Fax |
|
| Email |
Shabnamkausar1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Research Fund,Jawaharlal Institute of Postgraduate Medical Education and Research.
Dhanvantri Nagar
Puducherry
605006
India |
|
|
Primary Sponsor
|
| Name |
Intramural Research FundJawaharlal Institute Of Post Graduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research.
Dhanvantri Nagar
Puducherry
605006
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 MJ Kumari |
Jawaharlal Institute of Post Graduate Medical Education and Research |
4th Floor,Surgical Gastroenterology Department,Superspeciality Block,JIPMER,Puducherry
Pondicherry
PONDICHERRY |
9894595420
kumari_mj@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for human studies,JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K31||Other diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Progressive Muscle Relaxation Exercise |
The muscles of the body are divided into twelve groups:hands,biceps,andtriceps,shoulders, neck ,mouth ,jaw ,eyes and forehead,chest,abdomen,back,thighs,legs and feet muscles.Technique involves the systemic sequential tension in specific muscle group.Inhale deeply and tense a specific muscle group,hold this tension in the specific muscle group for 5 seconds and then released within 5 secondsslowly.Feel the relaxation for next 10 seconds.During the whole process person should keep breathing normally.Patients of the intervention group will be doing the exercise thrice daily for one week |
| Comparator Agent |
Standard Nursing Care |
The comparator agent(control group) will recieve standard nursing care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Admitted at least 2 days before the surgery
-Patient undergoingelective laparoscopic gastro intestinal surgery under general anesthesia
-Patient aged between 18 -60 Years
-Patient is able to read and understand either Tamil or
English.
-Similar Analgesic Dose
|
|
| ExclusionCriteria |
| Details |
-ASA (American Society of Anesthesiologists) grade II or more
-Not being oriented to time,place and person
-Having cognitive or affective impairment
-Having Other Co morbidities
- Having any major intra operative and post operative
complications
-Ventilated post operatively
-On Sedatives
|
|
|
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 |
| Effect of Progressive Muscle Relaxation Exercise on Post Operative Tolerance,Sleep Quality & Vital Signs patients undergoing Abdominal Surgery |
Data will be collected posoperatively at twenty four hours,seventy two hours & at one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
01/09/2023 |
| 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="6"
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
|
|
Progressive Muscle Relaxation is an actively engaging relaxation
technique developed by Edmund Jacobson in the 1920’s.PMR involves participants actively contracting muscles
to create tension and progressively releasing this.Non
pharmacological methods of managing post operative discomfort are safe, and
do not cause any adverse effects.Study results suggest that
Progressive Muscle Relaxation offer good improvement in relaxation at both
psychological and physiological level and it can be a essential component of
nursing care.
|
Demographic data
will be collected pre operatively for both Intervention group and Control
Group.For the Patients in
the Intervention group training sessions will be held by the researchers by demonstrating with the help of audio until
they master the technique preoperatively.Baseline data will be collected post
operatively for both the groups after getting physicians approval to intervene post
operatively.Participants of intervention group will be
asked to perform this relaxation technique for 20 minutes
thrice daily for 1 weeks and Control Group will receive standard care.Data will be collected for both the groups
after 24 hours,72 hours, and after 1 week time point after starting of
relaxation technique. |