Clinical trial NCT04782882: The Effect of Progressive Muscle Relaxation and Laughter Therapy on Women Undergoing In Vitro Fertilization
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 141
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Mental health state (anxiety)
timeFrame: Before intervention begins and through intervention completion on average of 15 days
measure: Mental health state (Depression)
timeFrame: Before intervention begins and through intervention completion on average of 15 days
Secondary outcomes:
measure: Fertility treatment results
timeFrame: Before intervention begins and a cycle of ovarian stimulation (15 days)
measure: Fertility treatment results
timeFrame: a cycle of ovarian stimulation (15 days)
measure: Fertility treatment results
timeFrame: 3-5 days after oocyte pick up day
measure: Fertility treatment results
timeFrame: 15 days after embryo transfer
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: Sibel KİYAK
state: Konya
Study officials:
References: