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

• ClinicalTrials.gov Identifier: NCT04782882
• Recruitment Status: Completed
• First Posted: March 4, 2021
• Last Update Posted: March 4, 2021
• Sponsor: Necmettin Erbakan University
• Information provided by (Responsible Party): Sibel Kıyak, Necmettin Erbakan University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infertility, Female	Behavioral: Progressive muscle relaxation+laughter therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 141 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Statistical and reporting blinding were provided in the study.
• Primary Purpose: Supportive Care
• Official Title: Effectiveness of Progressive Muscle Relaxation and Laughter Therapy on Mental Health and Treatment Outcomes in Women Undergoing In Vitro Fertilization: A Randomized Controlled Trial
• Actual Study Start Date: August 3, 2020
• Actual Primary Completion Date: August 18, 2020
• Actual Study Completion Date: December 29, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: intervention group; In the first session of the researcher (S.K.), the participants were explained the effects of anxiety and stress on the treatment in simple terms for 5 min. Then, information was given about the effects of laughter therapy and progressive muscle relaxation on the body. Laughter therapy was applied for 15-20 min. Then, the lights were turned off and progressive muscle relaxation exercises were performed for 15-20 min under candlelight and accompanied by music. The procedures were received as a group (2-6 people) in 3-4 face-to-face sessions.	Behavioral: Progressive muscle relaxation+laughter therapy; Laughter therapy:Laughter therapy is a technique that changes the mood by breathing correctly and by combining childish exercises with laughter exercises to turn into real laughter for no reason. Progressive muscle relaxation procedure: the participants were asked to tighten and relax large muscle groups in the body with deep breathing exercises. Progressive muscle relaxation was applied to the muscles of the head and face, neck, chest, back, arms, hands, abdomen, hips, legs and feet. The procedure was applied in a dark environment and accompanied by candlelight and relaxing music.
No Intervention: Control group; The control group then received routine care

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. Fertility treatment results [ Time Frame: Before intervention begins and a cycle of ovarian stimulation (15 days) ]
   Estradiol (E2) level
2. Fertility treatment results [ Time Frame: a cycle of ovarian stimulation (15 days) ]
   oocyte count
3. Fertility treatment results [ Time Frame: 3-5 days after oocyte pick up day ]
   embryo transfer status
4. Fertility treatment results [ Time Frame: 15 days after embryo transfer ]
   Rate of positive Hcg blood pregnancy test

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 46 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Turkey

Sibel KİYAK

Selçuklu, Konya, Turkey, 42100

Sponsors and Collaborators

Necmettin Erbakan University

More Information

• Responsible Party: Sibel Kıyak, Assist. Professor, Necmettin Erbakan University
• ClinicalTrials.gov Identifier: NCT04782882
• Other Study ID Numbers: NecmettinEU_Kiyak1
• First Posted: March 4, 2021
• Last Update Posted: March 4, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infertility; Infertility, Female