Evaluation of The Effect of Fertility Support Education Given to Infertile Couples

NCT06317571 | Completed

• 1 other identifier: CelalBayarU-SBF-OT-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment.

Conditions

Infertility

Keywords

stress; cortisol Level; pregnancy Outcome; infertility

Outcome Measures

Primary Outcomes (5)

• Infertility Stress Scale

  This scale, which can be applied to both men and women, consists of three subscales and 14 items. The sub-dimensions of the scale are personal space, marital space and social space. A high score from the subscales of the scale indicates that stress has increased, while a low score indicates that stress has decreased.

  two month

• Infertility Self-Efficacy Scale-Short Form

  The scale was developed to evaluate the self-efficacy perceptions of infertile individuals about their cognitive, emotional and behavioral skill strengths. A 10-item short form of this scale, which consists of 16 items, was created in 2006. A minimum of 8 and a maximum of 32 points are obtained from the scale, and the higher the score obtained from the scale, the higher the perception of self-efficacy is considered.

  two month

• Fertility Readiness Scale

  The scale consists of three sub-dimensions: "Hope and Awareness", "Positive Emotions and Thoughts", and "Ready Body and Brain". Getting a high score on this scale indicates strong fertility readiness. The minimum score from the scale is 23 points and the maximum score is 115 points. The median score of this scale is 56 and it is stated that this score can be taken as the cut-off value. A score of 56 points or higher from the scale indicates that the woman feels more ready for pregnancy.

  two month

• Fertiqol Quality of Life Scale

  The scale evaluates quality of life. The core module consists of four dimensions: emotional, mind-body, relational and social, and the treatment module consists of two sub-dimensions: treatment environment and treatment tolerance. The total score of the scale varies between 0-100, and an increase in the total score indicates an increase in the quality of life.

  two month

• Blood cortisol level

  An increase in blood cortisol level indicates that stress increases, and a decrease indicates that stress decreases.

  two month

Study Arms (2)

fertility support training

EXPERIMENTAL

The group will receive fertility support training.

Behavioral: fertility support education

routine care

NO INTERVENTION

They will receive routine care.

Interventions

fertility support education BEHAVIORAL

In the first module, female reproductive organs, the occurrence of pregnancy and the effect of stress on fertility are explained to women using models and training booklets. The effects of affirmation, which is one of the ways to positively affect the consciousness, and imagination, visualization and relaxation techniques, which are ways to positively affect the subconscious, on body and reproductive functions are explained. In the second module, women and their partners were also trained, and the effect of lifestyle on reproductive health was explained through the second module training booklet. In the third module, an example of a one-week program in which they could apply the methods described in the training before starting their treatments was introduced. In the fourth module, treatment process was explained to women and the practices described in the training were shared, which they could do to relax during this process.

fertility support training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosed with primary infertility
• have not received fertility support training before
• can speak Turkish

You may not qualify if:

• with psychiatric illness

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (1)

Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi

Manisa, 45060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Özge TOPSAKAL, PhD

  Manisa Celal Bayar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups with intervention group and control group

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 15, 2021
• Primary Completion: December 28, 2021
• Study Completion: August 10, 2022
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

TU (1)