Clinical trial NCT05345067: The Effect of Laughter Yoga on the Anxiety and Stress Levels of Women in the Postpartum Period
Official title: The Effect of Laughter Yoga on the Anxiety and Stress Levels of Women in the Postpartum Period: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laughter Yoga
Keywords: Laughter Yoga
Postpartum Period
Anxiety
Stress
Nurse
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 144
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 anxiety and stress levels of postpartum 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 Postpartum anxiety scale and the perceived stress scale were applied to women in both groups to determine their anxiety and 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 Postpartum anxiety scale and the perceived stress scale were administered to the women in both groups to re-determine their anxiety and stress levels.

Detailed description: This research is a randomized controlled study to evaluate the effect of Laughter yoga on the anxiety and stress levels of postpartum 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 128 women should be included in the study. Considering that there may be losses, it was decided to include 160 women in the study. By providing randomization, 160 women who met the sampling criteria and volunteered to participate in the study were divided into two groups as 80 experimental and 80 control. At the beginning of the study, the Postpartum anxiety scale and the perceived stress scale were applied to women in both groups to determine their anxiety and 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 Postpartum anxiety scale and the perceived stress scale were administered to the women in both groups to re-determine their anxiety and stress levels. In the study, 7 women from the experimental group and 9 women from the control group were excluded for various reasons. The study was conducted with 73 experimental and 71 control groups. The process of making analyzes and writing the final report continues. This study is financially supported by Atatürk University Scientific Research Coordination Unit. In addition, this study is carried out as a master's thesis accepted by Atatürk University Health Sciences Institute.

Eligibility criteria: Inclusion Criteria:

* be between the ages of 19-45
* Giving birth by vaginal / Caesarean section
* 1 month after birth
* Having a healthy baby
* Not experiencing any complications during birth and postpartum
* At least primary school graduate
* Not having a diagnosed psychiatric disease

Exclusion Criteria:

* Having a medical condition (hypertension, wound complication, etc.)
* Not regularly attending laughter yoga sessions (for the experimental group)
* Applying another alternative method to reduce anxiety and stress in the postpartum period

Primary outcomes:
measure: Questionnaire Form
timeFrame: up to 2 weeks
measure: Postpartum Specific Anxiety Scale
timeFrame: up to 2 weeks
measure: Perceived Stress Scale
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Postpartum Specific Anxiety Scale
timeFrame: up to 3 weeks
measure: Perceived Stress Scale
timeFrame: up to 3 weeks
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: