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Clinical Trials/NCT06426472
NCT06426472
Not yet recruiting
Not Applicable

The Effect of Web-Based Support Program on Psychosocial Health Status in Women With Unsuccessful IVF Experience

Istanbul University - Cerrahpasa0 sites120 target enrollmentMay 30, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Istanbul University - Cerrahpasa
Enrollment
120
Primary Endpoint
Depression (Beck Depression Inventory)
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this interventional study is to learn if web-based support program can improve the psychosocial health status in women with unsuccessful IVF experience. The main questions it aims to answer are:

Does web-based support decrease the depressive symptoms, anxiety and infertility-related stress? Does web-based support decrease the hopelessness? Does web-based support increase the coping skills with infertility-related stress?

Researchers will compare this intervention to a control group to see if web-based support program improves psychosocial health.

Participants will:

Use the web-based support intervention for 5 weeks or have no intervention. Complete the surveys on the website before and after the intervention.

Registry
clinicaltrials.gov
Start Date
May 30, 2025
End Date
August 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Istanbul University - Cerrahpasa
Responsible Party
Principal Investigator
Principal Investigator

Elif Balkan

PhD Student

Istanbul University - Cerrahpasa

Eligibility Criteria

Inclusion Criteria

  • Having at least three repeated unsuccessful IVF experiences,
  • Maximum one month has passed since the negative IVF experience,
  • Participating in the study voluntarily,
  • Being able to read, understand and communicate in Turkish.
  • Exclusion criteria
  • Not having access to the internet/not knowing how to use it,
  • Having any psychiatric disease/being in the 'severe depression' grade as a result of the Beck Depression Inventory,
  • Having at least one living child.
  • Exclusion criteria from the study in the stages after including the study:
  • Spontaneous pregnancy occurring,

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Depression (Beck Depression Inventory)

Time Frame: 24 months

Beck Depression Inventory (BDI) will be used to evaluate the participants' anxiety outcome. This inventory, whose validity and reliability in Turkish was studied by Hisli (1989), consists of a total of 21 items and four interpreted sub-dimensions. The scoring of the scale is a four-point Likert type (0 = positive statements about depression; 3 = negative statements about depression). The total score that can be obtained from the scale varies between 0-63; 0-9 points indicate minimal depression, 10-16 points indicate mild depression, 17-29 points indicate moderate depression, and 30-63 points indicate severe depression.

Infertility-related stress (The Infertility Stress Scale)

Time Frame: 24 months

The Infertility Stress Scale will be used to assess participants' infertility-related stress. Schmidt (2006) developed this scale in 1996. In our country, the validity and reliability of the scale was studied by Şahin Yılmaz (2012). This scale is a scale with a total of 14 items consisting of three sub-dimensions and answers are given in a Lykert type. Calculations per subdimensions requires a special formula for each subdimension. An increase in score is interpreted as an increase in stress.

Coping Skills with Infertility Stress (Coping with Infertility Stress Scale)

Time Frame: 24 months

Coping with Infertility Stress Scale: Developed by Schmidt (2006) in 1996. In our country, the validity and reliability of the scale was studied by Şahin Yılmaz (2012). This scale is a scale with a total of 19 items consisting of four sub-dimensions. e Active-Struggle Coping, Passive-Struggle Coping, Passive-Ignoring Coping and Meaning-Based Coping Method. Each subscale score can be calculated seperately.

Secondary Outcomes

  • Effect of the Web-based study program(24 months)
  • Hopelessness(24 months)

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