The Effect of Laughter Yoga on the Anxiety and Stress Levels of Women in the Postpartum Period

July 20, 2022 updated by: Aslı SİS ÇELİK, Ataturk University

The Effect of Laughter Yoga on the Anxiety and Stress Levels of Women in the Postpartum Period: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25240
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental: Laughter yoga session parts-1
Deep breathing exercises (5 minutes)
Behavioral: Experimental: Laughter yoga session parts-1
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: Experimental: Laughter yoga session parts-2
Warm-up exercises (10 minutes)
Behavioral: Experimental: Laughter yoga session parts-2
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: Experimental: Laughter yoga session parts-3
Childish games (10 minutes)
Behavioral: Experimental: Laughter yoga session parts-3
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: Experimental: Laughter yoga session parts-4
Laughter exercises (15 minutes)
Behavioral: Experimental: Laughter yoga session parts-4
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Questionnaire Form
Time Frame: up to 2 weeks
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
Time Frame: up to 2 weeks
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
Time Frame: up to 2 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postpartum Specific Anxiety Scale
Time Frame: up to 3 weeks
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 3 weeks
Perceived Stress Scale
Time Frame: up to 3 weeks
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. It contains 14 items in total. Self-efficacy and perception of stress It consists of two sub-dimensions. 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 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • aslı25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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