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

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782882
• Other study ID #: NecmettinEU_Kiyak1
• Status: Completed
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: December 29, 2020

Study information

• Verified date: March 2021
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: December 29, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 46 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sibel KIYAK	Selçuklu	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Fertility treatment results	Estradiol (E2) level	Before intervention begins and a cycle of ovarian stimulation (15 days)
Secondary	Fertility treatment results	oocyte count	a cycle of ovarian stimulation (15 days)
Secondary	Fertility treatment results	embryo transfer status	3-5 days after oocyte pick up day
Secondary	Fertility treatment results	Rate of positive Hcg blood pregnancy test	15 days after embryo transfer