NCT05345067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

April 19, 2022

Last Update Submit

July 20, 2022

Conditions

Keywords

Laughter YogaPostpartum PeriodAnxietyStressNurse

Outcome Measures

Primary Outcomes (3)

  • Questionnaire Form

    Prepared by the researcher; There are introductory information such as age, education level, family type and 24 questions about the postpartum period. This form determines the introductory characteristics of the participants. therefore no points are taken.

    up to 2 weeks

  • Postpartum Specific Anxiety Scale

    This scale was developed by Fallon et al. to evaluate postpartum anxiety symptoms. The Turkish adaptation of the scale was made by Duran in 2019. Since it was determined that some items could be in different groups in the adaptation to Turkish, it was decided to be one-dimensional and some items not to be in the Turkish version. The Turkish form of the scale was evaluated as one-dimensional and 47 items. It can be said that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level of anxiety.

    up to 2 weeks

  • Perceived Stress Scale

    It was developed by Cohen, Kamarck \& Mermelste in 1983 to measure the perceived stress of a person in any situation, and was adapted into Turkish by Eskin et al. It contains 14 items in total. Participants evaluated the items on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". 7 items containing positive statements are scored in reverse. Scoring ranges from 0 to 56, while a high score indicates that the person is highly stressed.

    up to 2 weeks

Secondary Outcomes (2)

  • Postpartum Specific Anxiety Scale

    up to 3 weeks

  • Perceived Stress Scale

    up to 3 weeks

Study Arms (4)

Experimental: Laughter yoga session parts-1

EXPERIMENTAL

Deep breathing exercises (5 minutes)

Behavioral: Experimental: Laughter yoga session parts-1

Experimental: Laughter yoga session parts-2

EXPERIMENTAL

Warm-up exercises (10 minutes)

Behavioral: Experimental: Laughter yoga session parts-2

Experimental: Laughter yoga session parts-3

EXPERIMENTAL

Childish games (10 minutes)

Behavioral: Experimental: Laughter yoga session parts-3

Experimental: Laughter yoga session parts-4

EXPERIMENTAL

Laughter exercises (15 minutes)

Behavioral: Experimental: Laughter yoga session parts-4

Interventions

Section 1: Deep breathing exercises: A deep breath is taken as far as possible by raising the arms up to the sky. Breathing is held for 4-5 seconds after deep inspiration. Breathing is performed rhythmically and slowly, while the arms are placed in a normal position. After deep inspiration, one can exhale either by forming the lips in the whistling position or by laughing. In each deep breathing exercise technique, the expiration time of the exhalation process should be longer than the inspiration time.

Experimental: Laughter yoga session parts-1

Section 2: Warm-up exercises (10 minutes): Hands are clapped by holding parallel to each other. The fingertips and the palms touch each other, stimulating the acupuncture points on both hands, and the individual's energy level rises. In order to further raise the energy level and synchronize the movements of the group, a rhythm is added in the form of 1-2, 1-2-3. After several rhythmic hand-clapping movements, one more movement is added. Hands are clapped by swinging left and right. Then, an audible rhythm in the form of ho, ho, ha-ha-ha is also added to the hand-clapping movement. People in the group look at each other, and smile.

Experimental: Laughter yoga session parts-2

Section 3: Childish games (10 minutes): Childish games are used that will help to laugh for no reason, just like a child. Imagining these games and plays, the arms are raised upwards in the form of a "Y" with palms facing the sky, motivating the group by saying "very good (clap), very good (clap), yes". The leader of laughter yoga speaks out "very good (clap), very good (clap), hey (arms to the right and left)" to keep the group's energy high and generate enthusiasm in the deep breathing exercises and laughter exercises sections. According to the energy and desire of the group, this section is completed after about 10 minutes.

Experimental: Laughter yoga session parts-3

Section 4: Laughter exercises (15 minutes): This section contains a variety of laughter exercises that will laugh, such as greetings, laughter cream, exploding balloon laughter, preparing and drinking strawberry milk, bonuses, hot soup, lion, aloha, bird, appreciation, elevator, and cream pie. A laugh is raised by doing only laughter exercises for no reason at all. At the end of this section, relaxation is achieved for about three minutes using deep breathing exercises. The group is given verbal guidance "Put your hand on your heart, feel your heartbeat, let's exhale with a smile, make a wish or pray, smile as if we had achieved our wish," and the laughter yoga session is terminated.

Experimental: Laughter yoga session parts-4

Eligibility Criteria

Age19 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • be between the ages of 19-45
  • Giving birth by vaginal / Caesarean section
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Aslı SİS ÇELİK

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The women in the experimental and control groups did not know which group they were in. Data were collected online due to the pandemic. Therefore, the researchers and the people who would conduct the analyzes did not know the women in the experimental and control groups. The women used a nickname to fill in the questions on the measurement tools.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 25, 2022

Study Start

January 1, 2022

Primary Completion

May 15, 2022

Study Completion

June 20, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations