- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04782882
The Effect of Progressive Muscle Relaxation and Laughter Therapy on Women Undergoing In Vitro Fertilization
Effectiveness of Progressive Muscle Relaxation and Laughter Therapy on Mental Health and Treatment Outcomes in Women Undergoing In Vitro Fertilization: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Konya
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Selçuklu, Konya, Turkey, 42100
- Sibel KİYAK
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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. |
No Intervention: Control group
The control group then received routine care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Before intervention begins and through intervention completion on average of 15 days
|
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.
|
Before intervention begins and through intervention completion on average of 15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fertility treatment results
Time Frame: Before intervention begins and a cycle of ovarian stimulation (15 days)
|
Estradiol (E2) level
|
Before intervention begins and a cycle of ovarian stimulation (15 days)
|
Fertility treatment results
Time Frame: a cycle of ovarian stimulation (15 days)
|
oocyte count
|
a cycle of ovarian stimulation (15 days)
|
Fertility treatment results
Time Frame: 3-5 days after oocyte pick up day
|
embryo transfer status
|
3-5 days after oocyte pick up day
|
Fertility treatment results
Time Frame: 15 days after embryo transfer
|
Rate of positive Hcg blood pregnancy test
|
15 days after embryo transfer
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NecmettinEU_Kiyak1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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