| CTRI Number |
CTRI/2025/02/080798 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Effectiveness of Jpmr vs relaxation music among asthmatic children ] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of Jacobsons progressive muscle relaxation vs relaxation music on depression, anxiety and health related quality of life among asthmatic children of 8-14 years of age in AIIMS Gorakhpur |
|
Scientific Title of Study
|
Effectiveness of Jacobsons progressive muscle relaxation vs relaxation music on anxiety, depression and health related quality of life among asthmatic children of 8-14 years of age in AIIMS Gorakhpur :A randomized control 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 |
Simran |
| Designation |
M.Sc Pediatric Nursing |
| Affiliation |
All India Institute of Medical Sciences ,Gorakhpur |
| Address |
college of nursing ,Aiims Gorakhpur 4th floor,uttar pradesh ,india
college of nursing ,Aiims Gorakhpur 4th floor,uttar pradesh ,india
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9306855878 |
| Fax |
|
| Email |
nsimran244@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Seema S Chavan |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences ,Gorakhpur |
| Address |
college of nursing ,Aiims Gorakhpur,4th floor,uttar pradesh,273008
college of nursing ,Aiims Gorakhpur,4th floor,uttar pradesh,273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9353437981 |
| Fax |
|
| Email |
seemaschavan23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Simran |
| Designation |
M.Sc Pediatric Nursing |
| Affiliation |
All India Institute of Medical Sciences ,Gorakhpur |
| Address |
college of nursing ,Aiims Gorakhpur,4th floor,uttar pradesh,273008
college of nursing ,Aiims Gorakhpur,4th floor,uttar pradesh,273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9306855878 |
| Fax |
|
| Email |
nsimran244@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Gorakhpur,uttar pradesh,pin code -273008,India |
|
|
Primary Sponsor
|
| Name |
Simran |
| Address |
All India Institute of Medical Sciences, College of Nursing ,Gorakhpur |
| 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 |
| Simran |
All India Institute of Medical Sciences , gorakhpur ,pediatric department includes IPD and OPD |
All India Institute of Medical Sciences ,Kunraghat ,Gorakhpur.PIN - 273008,UTTAR PRADESH
Gorakhpur
UTTAR PRADESH |
9306855878
nsimran244@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Im using two arms which includes jacobsons muscle progreeeive relaxation and relaxation music. |
Experimental 1 will be given Jacobsons muscle progressive relaxation will be given for 25 - 30 min. |
| Comparator Agent |
Regular continuous nursing care |
Continuous nursing care to the asthmatic children of age group of 8- 14 in the AIIMS Gorakhpur. |
| Intervention |
Relaxation music |
experimental 2 will be given relaxation music for about 10-15 minutes. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.The children who all admitted in Pediatric Ipd for asthma under age group of 8 - 14 years of age in AIIMS Gorakhpur.
2.The children who all are coming to OPD for asthma under age group of 8-14 years of age in AIIMS Gorakhpur. |
|
| ExclusionCriteria |
| Details |
1.Children who are not willing to participate.
2.Children who are critical and in intensive care unit. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be significant effectiveness in depression, anxiety and health related quality of life among asthmatic children of age group 8- 14 years in experimental and control group. |
2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be effectiveness in the depression, anxiety and health related quality of life with the selected demographic variables |
4 week |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
18/02/2025 |
| 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="0"
Months="4"
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 is randomized control trial that will be conducted at All India Institute of Medical Science Gotakhpuramong the asthmatic children on the depression, anxiety and health related quality of life to assess the effectiveness of Jacobson muscle progressive relaxation and relaxation music. The true experimental design ( pre- test post- test only control design) will be used in the study. The population of this study includes patients who all are admitted in the ipd and who all are coming to opd in the aiims Gorakhpur. A total of 84 patients will be chosen and will be allocated the experimental and control group. |