Skip to main content
Clinical Trials/NCT04782882
NCT04782882
Completed
Not Applicable

Effectiveness of Progressive Muscle Relaxation and Laughter Therapy on Mental Health and Treatment Outcomes in Women Undergoing In Vitro Fertilization: A Randomized Controlled Trial

Necmettin Erbakan University1 site in 1 country141 target enrollmentAugust 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Female
Sponsor
Necmettin Erbakan University
Enrollment
141
Locations
1
Primary Endpoint
Mental health state (Depression)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 3, 2020
End Date
December 29, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sibel Kıyak

Assist. Professor

Necmettin Erbakan University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Mental health state (Depression)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Fertility treatment results(15 days after embryo transfer)

Study Sites (1)

Loading locations...

Similar Trials