| CTRI Number |
CTRI/2021/03/031938 [Registered on: 12/03/2021] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Psychological intervention on parents of preterm babies |
|
Scientific Title of Study
|
Psychological stress in parents delivering preterm child and psychological intervention on them. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Harihara Prakash |
| Designation |
Professor And Principal |
| Affiliation |
K.M.Patel Institute Of Physiotherapy |
| Address |
K.M.Patel Institute Of Physiotherapy,
Bhaikaka University,
Shree Krishna Hospital
Gokalnagar
Karamsad
Anand
GUJARAT
388325
India |
| Phone |
8238238685 |
| Fax |
|
| Email |
hariharap@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Harihara Prakash |
| Designation |
Professor And Principal |
| Affiliation |
K.M.Patel Institute Of Physiotherapy |
| Address |
K.M.Patel Institute Of Physiotherapy,
Bhaikaka University,
Shree Krishna Hospital
Gokalnagar
Karamsad
Anand
GUJARAT
388325
India |
| Phone |
8238238685 |
| Fax |
|
| Email |
hariharap@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigar Mehta |
| Designation |
Assistant Professor |
| Affiliation |
K.M.Patel Institute Of Physiotherapy |
| Address |
K.M.Patel Institute Of Physiotherapy,
Bhaikaka University,
Shree Krishna Hospital
Gokalnagar
Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9824771843 |
| Fax |
|
| Email |
jigarnm@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| K.M.Patel Institute Of Physiotherapy
Bhaikaka University
Shree Krishna Hospital
Gokalnagar
Karamsad |
|
Primary Sponsor
Modification(s)
|
| Name |
self |
| Address |
K.M.Patel Institute Of Physiotherapy,
Bhaikaka University,
Shree Krishna Hospital
Gokal Agar
Karamsad |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrR Harihara Prakash |
K.M.Patel Institute Of Physiotheray |
K.M.Patel Institute of physiotherapy
Shree Krishna Hospital
GokalNager
Karamsad
388325
Anand
GUJARAT |
8238238685
hariharap@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z628||Other specified problems related to upbringing, (2) ICD-10 Condition: Z739||Problem related to life managementdifficulty, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
computer generated randomize control trial |
computer generated randomized parallel control trial will be used to divide 64 participants into 2 groups based on inclusion and exclusion criteria. Group 1 will receive the Acceptance and Commitment Therapy (ACT) and group 2 receive routine intervention in the form of psychological counseling which is as part of routine hospital protocol. Comparison of the level of stress amongst the parents will be assessed after the completion of 5 sessions and 3 months as follow up. |
| Intervention |
Psychological Intervention |
Total 64 participants will be divided into 2 groups based on inclusion and exclusion criteria. Before the commencement of the intervention, the participants of both the groups will be asked to fill up the parental Stress Scale : NICU. Group 1 will receive the ACT and group 2 will receive routine psychological counseling. In ACT there will be 5 sessions for parents who delivers preterm child. So, the first session will be for 10 minutes for building up rapport with participants to make them comfortable. Then in 2nd, 3rd, 4th session ACT will be given to participants which will last for 15 to 20 minutes. The six principals of ACT will be delivered as follows: first two principles will be achieved in 2nd session, then further two principles in 3rd session and last two principles will be achieved in 4th session. The last session that is in 5th session, the participants will be made to practice ACT so as to make them emotionally strong before they get discharged. At the end of intervention, the parental stress scale: NICU will be filled up by the participants to identify stress level of participants after taking part in intervention. After 3 months follow up will be taken either telephonically/personally to assess the stress level. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Parents who will deliver child less than 37 weeks of gestational age
2) Parents who will deliver first or subsequent preterm child (single or twins) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) |
Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) taken at baseline , after 5 session of intervention and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
20/03/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Psychological stress in parents who have delivered preterm child will be measured with PSS:NICU scale and after documentation of the psychological status of parents, Psychological intervention therapy would be given in the form of acceptance and commitment therapy(ACT) to the parents. ACT along with routine counselling to the intervention group. Routine counselling alone given to control group by nursing staff. 5 sessions will be given and then post psychological status of the parents will be again be measured. If parents in control group have significant distress ACT will be conducted after the post intervention data collection is done that is after the 5th day. |