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CompletedNCT04782882Updated Mar 4, 2021

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

An interventional study of Progressive muscle relaxation+laughter therapy in Infertility, Female, sponsored by Necmettin Erbakan University. Completed at 1 site in Turkey. Open to female participants aged 20 Years to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-04.

Sponsored by Necmettin Erbakan University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2020, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
141
Allocation
Randomized
Ages
20 Years to 46 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility, Female
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 141 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Necmettin Erbakan University is the lead sponsor of 198 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 46 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • A diagnosed psychiatric disorder,
  • prior experience in relaxation intervention,
  • Lack of ovarian response in previous treatments
  • Undergoing frozen embryo transfer.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
141 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

    The control group then received routine care

Interventions

  • BehavioralProgressive 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before intervention begins and through intervention completion on average of 15 days

  2. 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.

    Time frame: Before intervention begins and through intervention completion on average of 15 days

Secondary outcomes

  1. Fertility treatment results

    Estradiol (E2) level

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

  2. Fertility treatment results

    oocyte count

    Time frame: a cycle of ovarian stimulation (15 days)

  3. Fertility treatment results

    embryo transfer status

    Time frame: 3-5 days after oocyte pick up day

  4. Fertility treatment results

    Rate of positive Hcg blood pregnancy test

    Time frame: 15 days after embryo transfer

07

Study locations

1 site
  • Sibel KİYAK
    Selçuklu, Konya 42100, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04782882
Lead sponsor
Necmettin Erbakan University
Responsible party
Sibel Kıyak (Assist. Professor, Necmettin Erbakan University) — Principal investigator
First posted
Mar 4, 2021
Start date
Aug 3, 2020
Primary completion
Aug 18, 2020
Completion
Dec 29, 2020
Last update
Mar 4, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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