| CTRI Number |
CTRI/2018/06/014471 [Registered on: 08/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A randomized controlled trial to assess the impact of relaxation technique on stress, anxiety and milk output among postpartum mothers of hospitalized neonate in NICU, AIIMS, Delhi. |
|
Scientific Title of Study
|
A randomized controlled trial to assess the impact of relaxation technique on stress, anxiety and milk output among postpartum mothers of hospitalized neonate in NICU, AIIMS, Delhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUMAN |
| Designation |
MSc. Nursing student |
| Affiliation |
AIIMS |
| Address |
HNo 104 Village Madanpur Dabas Delhi
SUMAN Msc Nursing 1st year student college of nursing AIIMS
South
DELHI
110081
India |
| Phone |
9582260104 |
| Fax |
|
| Email |
sumandabas1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Joshi |
| Designation |
Lecturer, college of Nursing |
| Affiliation |
AIIMS |
| Address |
Dr. Poonam joshi
Lecturer,College of Nursing
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9818039744 |
| Fax |
|
| Email |
pjoshi495@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUMAN |
| Designation |
MSc. Nursing student |
| Affiliation |
AIIMS |
| Address |
HNo 104 Village Madanpur Dabas Delhi
SUMAN Msc Nursing 1st year student college of nursing AIIMS
South
DELHI
110081
India |
| Phone |
9582260104 |
| Fax |
|
| Email |
sumandabas1987@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences Ansari Nagar New Delhi 110029 |
| 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 |
| Suman |
AIIMS, New Delhi |
D3 ward Main building AIIMS New Delhi
South
DELHI |
9582260104
sumandabas1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Postpartum mothers of hospitalized neonate in neonatal intensive care unit., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Relaxation technique |
Mothers who delivered between 26-33 weeks of gestation will be screened based upon inclusion and exclusion criteria on 4±2 postpartum day. Participant will be stratified in two group i.e mothers delivered between 26-33 weeks of gestation and 30-33 weeks of gestation. Participant information sheet will be given to them and informed consent will be obtained from mothers who are willing to participate. Randomization for intervention and control group will be done based on computer generated sealed envelope. Demographic data of the mothers will be assessed. Data will be collected to assess the stress and anxiety using the questionnaires on 4±2 day of delivery from both the groups. Introduction and demonstration of relaxation technique will be done by Yoga expert to the experiment group on the day of enrollment .Control group will get routine care in the ward. Subjects in experimental group will perform relaxation technique for 10 days after enrolling in study, under the guidance of yoga expert and researcher. On 15±2 day after enrolling the study, again data will be obtained regarding stress, anxiety and milk output measurement scale from both control and intervention group. One day prior to discharge, breast feeding status will be checked in both intervention and control group. |
| Intervention |
Relaxation technique |
Relaxation technique will be done by postpartum mothers in intervention group. Relaxation technique will be 30 minute session consist of deep breathing, Suksham vyayam, Anulom vilom, brahmari and muscle relaxation. |
| Comparator Agent |
Stress, anxiety and milk output. |
Mother in control group will not do relaxation technique. stress, anxiety and milk output will be compared between experimental and control group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Mothers of hospitalized neonate:
1.Delivered between 26-33 weeks of gestation in AIIMS.
2.Hemodynamically stable.
3.Willing to participate
|
|
| ExclusionCriteria |
| Details |
Related to mother
1.Taking psychotropic drug.
2.Having NICU experience in previous delivery.
3.Unable to perform relaxation technique due to disease condition i.e infection at suture site, Heart disease, severe anemia etc.
Related to Neonate
1.Major congenital anomalies requiring immediate surgical intervention.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relaxation technique can decrease stress, anxiety which will increase milk output in postpartum mothers of hosptalized neonate in NICU. |
July 2017- December 2017 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Breast feeding status at discharge may improve of neonate. |
July 2017- December 2017 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2017 |
| Date of Study Completion (India) |
25/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Mothers who delivered between 26-33 weeks of gestation will be screened based upon inclusion and exclusion criteria on 4±2 postpartum day. Participant information sheet will be given to them and informed consent will be obtained from mothers who are willing to participate. Randomization for intervention and control group will be done based on computer generated sealed envelope. Demographic data of the mothers will be assessed. Data will be collected to assess the stress and anxiety using the questionnaires on 4±2 day of delivery from both the groups. Introduction and demonstration of relaxation technique will be done by Yoga expert to the experiment group on the day of enrollment .Control group will get routine care in the ward. Subjects in experimental group will perform relaxation technique for 10 days after enrolling in study, under the guidance of yoga expert and researcher. On 15±2 day after enrolling the study, again data will be obtained regarding stress, anxiety and milk output measurement scale from both control and intervention group. One day prior to discharge, breast feeding status will be checked in both intervention and control group. |