| CTRI Number |
CTRI/2024/10/075211 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Counselling on depression in infertility couples. |
|
Scientific Title of Study
|
The Effect of psychosocial counselling on Depression
and Fertility Quality of life in couples embarking on
infertility treatment
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 |
Dr Priyanka Kathuria |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences and technology, Jodhpur |
| Address |
Department of Obstetrics and Gynecology,
AIIMS, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7014982778 |
| Fax |
|
| Email |
dr.priyankathuria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhagyashree Umarwal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences and technology, Jodhpur |
| Address |
Department of Obstetrics and Gynecology,
AIIMS, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7976316934 |
| Fax |
|
| Email |
bhagyashreeumarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashree Umarwal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences and technology, Jodhpur |
| Address |
Department of Obstetrics and Gynecology,
AIIMS, Jodhpur
RAJASTHAN
342005
India |
| Phone |
7976316934 |
| Fax |
|
| Email |
bhagyashreeumarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences Basni Phase-II, Jodhpur, Rajasthan, India 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences and technology Jodhpur |
| Address |
All India Institute of Medical Sciences and technology, Basni Phase II, Jodhpur, Rajasthan, India 342005 |
| Type of Sponsor |
Government 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 |
| Dr Bhagyashree Umarwal |
All India Institute Of Medical Sciences , India , Rajasthan ,Jodhpur |
Department of Obstetrics and Gynecology, Out patient department , Block 2-C Room No 245
Jodhpur
RAJASTHAN |
7976316934
bhagyashreeumarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of medical sciences, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Psychosocial counselling |
The psychological intervention will consist of three sessions of 20-30 minutes, and at the next visit he will fill out three questionnaires. The first evaluation is a basic examination that includes psychoeducation, in which
women are explained about the treatment process and the positive impact of good mental health on treatment outcomes. At the second visit (2 weeks later), the infertile couple was followed up as part of
the routine protocol, reports were reviewed, and her second session of psychoeducational counseling was administered to the intervention group. It also includes audio and video relaxation techniques |
| Comparator Agent |
Routine care |
In the routine care group, a balanced diet and regular physical activity roles and routine assessments are performed. Four weeks later, a routine protocol follows, with coping skills training focused on acceptance and positive reassessment as coping strategies. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Both |
| Details |
Infertile couples attending Gynecology OPD planned for first cycle of infertility treatment |
|
| ExclusionCriteria |
| Details |
1 Female more than 42years
2 Previously undergone Infertility treatment
3 Females diagnosed with severe depression
4 Any history of psychiatric illness
5 Not consenting to be part of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of psychosocial counselling on depression score in couples
embarking on infertility treatment. |
2 weeks, 6 weeks and 10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of psychosocial counselling on fertility quality of life in couples embarking on infertility treatment |
2 weeks, 6 weeks and 10 weeks |
| To evaluate the impact of psychosocial counselling on coping skills of couples during infertility treatment. |
2 weeks, 6 weeks and 10 weeks |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
25/10/2024 |
| 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 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
|
This will be a randomized controlled study. All patients who meet study eligibility will be invited to
enroll at the OPD visit. Case evaluation will be done and patient will be recruited . All eligible patients
, questionnaire (BDI-II, FERTIQOL and BRIEF COPE ) to be filled, available in hindi version.
Assistance will be given if patient not able to read or write . Male or female patient with DASS score
having moderate to severe scoring will be excluded from the study and reffered to psychiatry
department . Of all patients recruited in total, each patient will be randomly assigned to one of her
two groups. Routine care group or intervention group. At the first visit to OPD, eligible couples in both
groups will be asked to complete the BDI-II, FERTIQOL, and her BRIEF COPE questionnaires. At
the same time, the intervention group’s first counseling session will take place. The psychological
intervention will consist of three sessions of 20-30 minutes, and at the next visit he will fill out three
questionnaires. The first evaluation is a basic examination that includes psychoeducation, in which
women are explained about the treatment process and the positive impact of good mental health on
treatment outcomes. At the second visit (2 weeks later), the infertile couple was followedup as part of
the routine protocol, reports were reviewed, and her second session of psychoeducational counseling
was administered to the intervention group. It also includes audio and video relaxation techniques. In
the RC group, a balanced diet and regular physical activity roles and routine assessments are
performed. Four weeks later, a routine protocol follows, with coping skills training focused on
acceptance and positive reassessment as coping strategies. The BDI-II, FertiQOL, and Brief COPE
questionnaires will be refilled to compare to baseline and to compare improvement in scores with
ongoing counseling sessions. Finally, the questionnaire is evaluated and the results analyzed. |