Laughter YogaNCT05345067
The Effect of Laughter Yoga on the Anxiety and Stress Levels of Women in the Postpartum Period
A study testing Experimental: Laughter yoga session parts-1, Experimental: Laughter yoga session parts-2 and Experimental: Laughter yoga session parts-3 in people with Laughter Yoga, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laughter Yoga
- What is being tested?
- Experimental: Laughter yoga session parts-1, Experimental: Laughter yoga session parts-2 and Experimental: Laughter yoga session parts-3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Laughter Yoga
- Being tested
- Experimental: Laughter yoga session parts-1, Experimental: Laughter yoga session parts-2, Experimental: Laughter yoga session parts-3, Experimental: Laughter yoga session parts-4
- Keywords
- Laughter Yoga, Postpartum Period, Anxiety, Stress, Nurse
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Laughter yoga session parts-1Behavioural
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-2Behavioural
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-3Behavioural
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-4Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Laughter yoga session parts-1 | Experimental | Deep breathing exercises (5 minutes) Receives: Behavioral: Experimental: Laughter yoga session parts-1 |
| Experimental: Laughter yoga session parts-2 | Experimental | Warm-up exercises (10 minutes) Receives: Behavioral: Experimental: Laughter yoga session parts-2 |
| Experimental: Laughter yoga session parts-3 | Experimental | Childish games (10 minutes) Receives: Behavioral: Experimental: Laughter yoga session parts-3 |
| Experimental: Laughter yoga session parts-4 | Experimental | Laughter exercises (15 minutes) Receives: Behavioral: Experimental: Laughter yoga session parts-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 2 weeks
Secondary outcomes (2)
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.
Measured: up to 3 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. 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.
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Jan 2022
- Primary completion15 May 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laughter YogaStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı SİS ÇELİK, Ataturk University
- Investigators
- Aslı SİS ÇELİK, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345067
- Sponsor's protocol ID
- aslı25
- Status last verified
- Jul 2022
- First submitted
- 19 Apr 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on the Anxiety and Stress Levels of Women in the Postpartum Period: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05345067
- Acronym / sponsor ID
- aslı25
- Conditions
- Laughter Yoga
- Keywords
- Laughter Yoga, Postpartum Period, Anxiety, Stress, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental: Laughter yoga session parts-1 | Experimental | Behavioral: Experimental: Laughter yoga session parts-1Deep breathing exercises (5 minutes) |
| Experimental: Laughter yoga session parts-2 | Experimental | Behavioral: Experimental: Laughter yoga session parts-2Warm-up exercises (10 minutes) |
| Experimental: Laughter yoga session parts-3 | Experimental | Behavioral: Experimental: Laughter yoga session parts-3Childish games (10 minutes) |
| Experimental: Laughter yoga session parts-4 | Experimental | Behavioral: Experimental: Laughter yoga session parts-4Laughter exercises (15 minutes) |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Laughter yoga session parts-1Section 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. | Behavioural | Experimental: Laughter yoga session parts-1 |
| Experimental: Laughter yoga session parts-2Section 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. | Behavioural | Experimental: Laughter yoga session parts-2 |
| Experimental: Laughter yoga session parts-3Section 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. | Behavioural | Experimental: Laughter yoga session parts-3 |
| Experimental: Laughter yoga session parts-4Section 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. | Behavioural | Experimental: Laughter yoga session parts-4 |
Primary outcome
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.
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.
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.
2 secondary outcomes
Postpartum Specific Anxiety Scale
Time frame: up to 3 weeks
Perceived Stress Scale
Time frame: up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslı SİS ÇELİK study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Laughter yoga session parts-1, Experimental: Laughter yoga session parts-2 and Experimental: Laughter yoga session parts-3 in people with Laughter Yoga, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire Form (time frame: up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.