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临床试验/CTRI/2024/10/075211
CTRI/2024/10/075211尚未招募不适用

The Effect of psychosocial counselling on Depression and Fertility Quality of life in couples embarking on infertility treatment A Randomized Controlled trial

All India Institute of Medical Sciences and technology Jodhpur1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年10月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
To assess the effect of psychosocial counselling on depression score in couples

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 42.00 Year(s)(—)
性别
All

入选标准

  • Infertile couples attending Gynecology OPD planned for first cycle of infertility treatment.

排除标准

  • 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.

结局指标

主要结局

To assess the effect of psychosocial counselling on depression score in couples

时间窗: 2 weeks, 6 weeks and 10 weeks

embarking on infertility treatment.

时间窗: 2 weeks, 6 weeks and 10 weeks

次要结局

  • 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)

研究者

发起方
All India Institute of Medical Sciences and technology Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Priyanka Kathuria

All India Institute of Medical Sciences and technology, Jodhpur

研究点 (1)

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