| CTRI Number |
CTRI/2024/09/073444 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Jacobsons Muscle relaxation therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Relaxation Therapy in Reducing Stress and Anxiety of Mothers of NICU Admitted Babies |
|
Scientific Title of Study
|
Effectiveness of Jacobson’s muscle relaxation therapy on stress and anxiety among mothers of NICU admitted babies in selected paediatric hospitals at Davangere. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRASANNAKUMAR D R |
| Designation |
PhD Scholar/Associate Professor |
| Affiliation |
Bapuji College of Nursing |
| Address |
Department of Pediatric Nursing, Bapuji College of Nursing
S S General Hospital Campus
K R Road, Davangere
Davanagere
KARNATAKA
577001
India |
| Phone |
9844993531 |
| Fax |
|
| Email |
prasanna.spb2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRASANNAKUMAR D R |
| Designation |
PhD Scholar/Associate Professor |
| Affiliation |
Bapuji College of Nursing |
| Address |
Department of Pediatric Nursing, Teaching Block,
Bapuji College of Nursing
S S General Hospital Campus
K R Road, Davangere
Davngere, Karnataka, India
Davanagere
KARNATAKA
577001
India |
| Phone |
9844993531 |
| Fax |
|
| Email |
prasanna.spb2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Bharathi |
| Designation |
Principal |
| Affiliation |
Karnataka College of Nursing |
| Address |
Department of Pediatric Nursing, Nursing Block,
Karnataka College of Nursing
No. 33/2, Thirumenahalli
Hegde Nagar Main Road
Yalahanka
Bangalore
Karnataka, India
Bangalore
KARNATAKA
560064
India |
| Phone |
9886590478 |
| Fax |
|
| Email |
bharathiramesh2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bapuji Child Health Institute, Davangere, Karnataka, India -577002 |
| Chigateri General Hospital, Davangere, Karnataka, India 577002 |
|
|
Primary Sponsor
|
| Name |
Prasannakumar D R |
| Address |
PhD Scholar/ Associate Professor
Department of Pediatric Nursing, Teaching Block, Bapuji College of Nursing
Davangere, Karnataka, India 577001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr M Bharathi |
Principal, Karnataka College of Nursing, Bangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Prasannakumar |
Bapuji Child Health Institute |
NICU
Department of Neonatology
Bapuji Child Health Institute
P J Extension, Davangere
Davanagere
KARNATAKA |
8660144912
prasanna.spb2@gmail.com |
| DR Prasannakumar |
Chigateri General Hospital |
Medical College Road
P J Extension
Davangere, Karnataka, India
577002
Davanagere
KARNATAKA |
08660144912
prasanna.spb2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JJM Medical College, Davangere |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
screening for Stress and Anxiety |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jacobsons Muscle Relaxation therapy |
The progressive relaxation of each set of muscles in a sequence. |
| Comparator Agent |
Waitlist control |
Mothers of NICU admitted babies will be receiving routine care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Mothers whose high-risk neonates admitted in level II and Level III care of NICU.
2. The mothers who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Mothers whose babies are admitted for the observation in NICU.
2. Mothers whose babies are on routine care in NICU.
3. Mothers with postpartum psychosis.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of Jacobson’s muscle relaxation therapy on stress and anxiety among mothers of NICU admitted babies |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulse rate, Blood Pressure & Palpitations among mothers of NICU admitted babies |
1 Month |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 1 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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 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 purpose of this study was to evaluate the Effectiveness of Jacobson’s Muscle Relaxation Therapy on Stress and Anxiety Among Mothers of NICU Admitted Babies in Selected Paediatric Hospitals at Davangere" aims to assess the impact of Jacobson’s Muscle Relaxation Therapy (JMRT) on reducing stress and anxiety levels in mothers whose newborns are admitted to the Neonatal Intensive Care Unit (NICU). The standardized Parental Stress Scale: NICU (PSS:NICU) scale and Parental Anxiety Screening Scale (PASS) will be used to assess the level of stress and anxiety of mothers of NICU admitted babies. After administration of JMRT, post test level of anxiety and stress assessed on 2nd,5th and 8th day to evaluate the effectiveness of JMRT on the level of stress and anxiety of mothers of NICU admitted Babies. |