Clinical trial NCT05831280: The Effect of Laughter Yoga on the Stress Levels of Infertility Women
Official title: The Effect of Laughter Yoga on the Stress Levels of Infertility Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Laughter Yoga
Keywords: Laughter Yoga
Infertility
Stress
Nurse
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. Randomization was provided in the sample included in the study, and it was divided into experimental and control groups. At the beginning of the study, the Infertility Stress Scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks. No application was made to the control group. After 4 weeks, the Infertility Stress Scale was administered to the women in both groups to re-determine their stress levels.

Detailed description: This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. At the beginning of the study, necessary ethics committee permission and institutional permissions were obtained. Both of the researchers have a certificate of leadership in laughter yoga. As a result of the power analysis, it was determined that 80 women should be included in the study. Considering that there may be losses, it was decided to include 90 women in the study. By providing randomization, 90 women who met the sampling criteria and volunteered to participate in the study were divided into two groups as 45 experimental and 45 control. At the beginning of the study, the Infertility stress scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks, two sessions a week. No application was made to the control group. After 4 weeks, the Infertility stress scale was administered to the women in both groups to re-determine their stress levels.

Eligibility criteria: Inclusion Criteria:

* be between the ages of 19-45
* have been diagnosed with infertility
* At least primary school graduate
* Not having a diagnosed psychiatric disease
* Will not have an ovulation pick up process, Intrauterine insemination and Embryo transfer procedure in the next 1 month

Exclusion Criteria:

* Have ovulation pick up process in the last 1 month
* undergoing Intrauterine insemination in the last 1 month
* undergoing an Embryo transfer in the last 1 month
* Not regularly attending laughter yoga sessions (for the experimental group)
* Applying another alternative method to reduce stress during the research process

Primary outcomes:
measure: Stress levels of women
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
state: Yakutiye
Study officials:
affiliation: Ataturk University
name: Aslı SİS ÇELİK
role: STUDY_DIRECTOR
References: