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

NCT04782882 | Completed

• 1 other identifier: NecmettinEU_Kiyak1
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (2)

• Mental health state (anxiety)

  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.

  Before intervention begins and through intervention completion on average of 15 days

• Mental health state (Depression)

  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.

  Before intervention begins and through intervention completion on average of 15 days

Secondary Outcomes (4)

• Fertility treatment results

  Before intervention begins and a cycle of ovarian stimulation (15 days)

• Fertility treatment results

  a cycle of ovarian stimulation (15 days)

• Fertility treatment results

  3-5 days after oocyte pick up day

• Fertility treatment results

  15 days after embryo transfer

Study Arms (2)

intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group then received routine care

Interventions

Progressive muscle relaxation+laughter therapy BEHAVIORAL

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.

intervention group

Eligibility Criteria

• Age: 20 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Sibel KİYAK

Selçuklu, Konya, 42100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistical and reporting blinding were provided in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Professor

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 4, 2021
• Study Start: August 3, 2020
• Primary Completion: August 18, 2020
• Study Completion: December 29, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

TU (1)