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Completed

NCT Number: NCT04782882

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

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.

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Key information

Conditions

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

Age range

20 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sibel KİYAK

Selçuklu, Konya, 42100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 4, 2021
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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