The Effect of Progressive Muscle Relaxation and Laughter Therapy on Women Undergoing In Vitro Fertilization

Not Applicable

Completed

• Conditions: Infertility, Female

• Registration Number: NCT04782882
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

Purpose: This study was aimed to evaluate the effect of progressive muscle relaxation exercises and laughter therapy on the mental health and treatment outcomes of women receiving IVF treatment.

Design: Randomized controlled trial with two parallel groups Methods: Participants were randomly assigned to the intervention (IG; n = 71) and control group (CG; n = 70). The progressive muscle relaxation and laughter therapy was administered to women in the intervention group in the IVF center for 3-4 times and 40 minutes. The CG received routine care. Data were collected using baseline and oocyte retrieval day STAI and BDI.

Detailed Description

Infertility, one of the important components of reproductive health, affects one in four couples in developing countries.The emergence of assisted reproductive techniques such as in vitro fertilization (IVF) gives infertile couples the opportunity to have both pregnancy and a baby. Couples are affected emotionally during IVF treatment and women experience more problems than men. The majority of women experience emotional problems such as anxiety and depression because of infertility, invasive treatment procedures, physiological effects of gonadotropin stimulation and positive outcome expectation.Considering the effect of anxiety and depression on infertile women, it is important to examine the effectiveness of progressive muscle relaxation exercises and laughter therapy as complementary therapy in psychosocial care.

Study Timeline

• Study Start: 2020-08-03
• Primary Completion: 2020-08-18
• Study Completion: 2020-12-29
• Study First Submitted: 2021-02-25
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study First Posted: 2021-03-04
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

Inclusion Criteria

• Women between the ages of 20 and 46,
• Literate in Turkish language,
• Diagnosed with infertility by an obstetrician or medical doctor
• Those with primary or secondary infertility

Exclusion Criteria

• A diagnosed psychiatric disorder,
• prior experience in relaxation intervention,
• Lack of ovarian response in previous treatments
• Undergoing frozen embryo transfer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mental health state (Depression)	Before intervention begins and through intervention completion on average of 15 days	State Trait Anxiety Inventory (STAI): To measure anxiety levels of the participants, the Turkish version of STAI developed by Spielberger was used. High scores indicate high anxiety level, while low scores indicate less anxiety level.
Mental health state (anxiety)	Before intervention begins and through intervention completion on average of 15 days	Beck Depression Inventory: The Beck Depression Inventory (BDI) is a 21-item self-reporting scale consisting of emotional, cognitive, somatic, and motivational components to measure the level and severity changes of depressive symptoms. In BDI, it is seen that as the total score obtained from the scale increases, the individual's level of experiencing depressive emotions increases proportionally.

Secondary Outcome Measures

Name	Time	Method
Fertility treatment results	15 days after embryo transfer	Rate of positive Hcg blood pregnancy test

Trial Locations

Locations (1)

Sibel KİYAK; 🇹🇷 Selçuklu, Konya, Turkey