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

Primary Purpose

Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive muscle relaxation+laughter therapy
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility, Female

Eligibility Criteria

20 Years - 46 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sibel KİYAK

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

Control group

Arm Description

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.

The control group then received routine care

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Fertility treatment results
Estradiol (E2) level
Fertility treatment results
oocyte count
Fertility treatment results
embryo transfer status
Fertility treatment results
Rate of positive Hcg blood pregnancy test

Full Information

First Posted
February 25, 2021
Last Updated
March 2, 2021
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT04782882
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
August 18, 2020 (Actual)
Study Completion Date
December 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Statistical and reporting blinding were provided in the study.
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group then received routine care
Intervention Type
Behavioral
Intervention Name(s)
Progressive muscle relaxation+laughter therapy
Intervention Description
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 Outcome Measure Information:
Title
Mental health state (anxiety)
Description
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
Title
Mental health state (Depression)
Description
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 Outcome Measure Information:
Title
Fertility treatment results
Description
Estradiol (E2) level
Time Frame
Before intervention begins and a cycle of ovarian stimulation (15 days)
Title
Fertility treatment results
Description
oocyte count
Time Frame
a cycle of ovarian stimulation (15 days)
Title
Fertility treatment results
Description
embryo transfer status
Time Frame
3-5 days after oocyte pick up day
Title
Fertility treatment results
Description
Rate of positive Hcg blood pregnancy test
Time Frame
15 days after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Sibel KİYAK
City
Selçuklu
State/Province
Konya
ZIP/Postal Code
42100
Country
Turkey

12. IPD Sharing Statement

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

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