Abdominal SurgeryNCT05317091
The Effect of Laughter Yoga on Nurses' Perceived Stress Burnout and Life Satisfaction During the Pandemic Period
A study testing Laughter yoga practiced in people with Abdominal Surgery and Hypertension, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effects of laughter yoga on the perceived stress, burnout and life satisfaction of nurses working actively during the pandemic period. A total of 120 nurses, determined by power analysis, were included in the randomized controlled study. The study included 2 groups. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Surgery, Hypertension, Done Laughter Yoga Before
- What is being tested?
- Laughter yoga practiced
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2021to 15 Mar 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not have undergone abdominal surgery in the past three months
- Uncontrollable hypertension
- Without epilepsy
Who cannot join
- Antidepressant etc. nurses using drugs
- Not attending sessions regularly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laughter Yoga on Nurses' Perceived Stress Burnout and Life Satisfaction During the Pandemic Period: A Randomized Controlled Trial
This study aimed to determine the effects of laughter yoga on the perceived stress, burnout and life satisfaction of nurses working actively during the pandemic period. A total of 120 nurses, determined by power analysis, were included in the randomized controlled study. The study included 2 groups. (A group of nurses who have active contact with patients diagnosed with or at risk of covid-19, group B: nurses who have active contact with patients diagnosed with or at risk of covid-19 and participate in laughter yoga practice. Laughter yoga; immune system antibodies and endorphin hormone. It has been proven by experimental studies that there is a connection between the two, that it has a healing effect, that it accelerates the circulatory system as an adverse effect to stress, and that it has a vasodilation effect in the vessels.
Read the detailed description
The study data were collected by the researchers using online systems with the snowball method due to the pandemic. The inclusion criteria of the study (not having undergone abdominal surgery in the last three months, not having uncontrolled hypertension, not having glaucoma, hernia, epilepsy, not having received a psychiatric diagnosis-treatment, not having received a diagnosis-treatment for sleep problems, having done laughter yoga before) The study consisted of 100 nurses who agreed to participate in the study. Introductory features form consisting of 13 questions, Maslach Burnout Scale and Life Satisfaction Scale, Perceived Stress Scale and life satisfaction scale were used to collect data. Research data were collected in 3 months. During the study, 9 people from the experimental group (8 people did not attend the sessions regularly, 1 person left voluntarily), 10 people from the control group (he left voluntarily) quit the study. Finally, the research was completed with 101 nurses, 51 of whom were in the experimental group and 50 in the control group.
- Conditions
- Abdominal Surgery, Hypertension, Done Laughter Yoga Before, Epilepsy
- Being tested
- Laughter yoga practiced
- Keywords
- Pandemic, Nurse, Stress, Burnout, Life satisfaction, Laughter yoga
- Medical subject headings
- Hypertension, Epilepsy, Burnout, Psychological, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yoga practicedOther
In this study, 8 sessions of laughter yoga were applied to the nurses in the experimental group as an intervention, twice a week for 4 weeks. Due to the Covid-19 pandemic; Laughter Yoga sessions were held on the web through the 'ZOOM' program.
For this reason, it is recommended that the laughter yoga sessions be done with a group and that the group should consist of at least five people in order to provide group dynamics. Sessions are planned according to the days and hours that nurses can attend. Sessions 1st group Monday-Thursday between 12:00-13:00; 2nd group Tuesday-Friday between 17:00-18:00; The third group was held on Wednesday-Saturday between 20:00-21:00. The nurses were constantly contacted (whatsapp, phone) to ensure that they attend the sessions regularly and that there is no interruption in the sessions. No experiment was performed on the control group during the study. However, after the research, a 4-week laughter yoga was given to the nurses who wanted it.
| Study group | Role | What they receive |
|---|---|---|
| Laughter yoga practice | Experimental | Laughter yoga for nurses The experimental group was divided into three groups as 18-17-16 people. Sessions 1st group Monday-Thursday between 12:00-13:00; 2nd group Tuesday-Friday between 17:00-18:00; The third group was held on Wednesday Saturday between 20:00-21:00.laughter yoga for nurses-Deep breathing exercises Deep breathing exercises (5 minutes), Warm-up exercises (10 minutes) laughter yoga for nurses-Childish games Childish games (10 minutes), Laughter exercises (15 minutes). Receives: Other: Laughter yoga practiced |
| Laughter yoga session parts-1 | Experimental | Deep breathing exercises (5 minutes) Breathing is held for 4-5 seconds after deep inspiration. While the arms are brought to the normal position, exhale slowly and rhythmically. When expressing after deep inspiration, the lips can be pursed as if whistling or exhaled with laughter. Receives: Other: Laughter yoga practiced |
| Laughter yoga session parts-2 | Experimental | Warm-up exercises (10 minutes) Rhythm of 1-2, 1-2-3 is added to increase the energy level even more and synchronize the movements of the group. After a few rhythmic clapping movements, another movement is added. Whisking hands left and right. Then an audible rhythm of ho, ho, ha-ha-ha is added to the clapping gesture. Make eye contact with people in the group and smile at them. Receives: Other: Laughter yoga practiced |
| Laughter yoga session parts-3 | Experimental | Childish games (10 minutes) Childlike games are used to help laugh without reason just like a child. The group is motivated by visualizing these games in their minds, raising the arms up in the form of a "Y" letter, and saying "very good (applause), very good (applause), hey" with palms facing the sky. Receives: Other: Laughter yoga practiced |
| Laughter yoga session parts-4 | Experimental | Laughter exercises (15 minutes) This section includes a variety of laughter exercises such as greetings, strawberry milk, conductor, bonus, hot soup, lion, aloha, bird, appreciation, laughter lotion, elevator, cream cake, and bursting balloon laughter. Receives: Other: Laughter yoga practiced |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form (questionnaire)
In this form prepared by the researchers; There are a total of 9 questions including age, gender, education level, marital status, working year, frequently worked shift, Covid-19 passing and being vaccinated, whether or not he has knowledge about laughter yoga.
Measured: up to 2 weeks
Perceived Stress Scale
The scale, which was created in order to understand how stressful individuals perceive certain events they experience, consists of 14 items, graded in a 5-point Likert type. In the scale, 7 items containing positive statements are reverse scored. The score range of the scale ranges from 0 to 56, and a high score indicates a high level of stress. The internal consistency coefficient of the scale was calculated as 0.84. In this study, the Cronbach alpha internal consistency coefficient was found to be 0.75.
Measured: up to 5 weeks]
Maslach Burnout Scale
The scale, consisting of 22 items and three sub-dimensions, is in the 5-point Likert type. The sub-dimensions of the scale are emotional exhaustion, depersonalization and personal achievement. Positive statements in the dimension of personal achievement are reverse coded. The high mean score of the emotional exhaustion and depersonalization sub-dimensions and low personal achievement mean scores indicate high burnout. The lowest score that can be obtained from the scale is 0 and the highest score is 88. The Cronhbach Alpha values of the scale were found to be 0.83 for emotional exhaustion, 0.65 for depersonalization and 0.72 for personal achievement.
Measured: up to 5 weeks
Life Satisfaction Scale
There are 5 items in the scale, and each item is arranged according to a 7-point answer system. A score between 5-35 can be obtained from the scale. Higher scores indicate higher life satisfaction. The Cronbach Alpha value of the scale is .88. In this study, the Cronbach Alpha coefficient was found to be .87.
Measured: up to 5 weeks
Secondary outcomes (3)
Perceived Stress Scale
The scale, which was created in order to understand how stressful individuals perceive certain events they experience, consists of 14 items, graded in a 5-point Likert type. In the scale, 7 items containing positive statements are reverse scored. The score range of the scale ranges from 0 to 56, and a high score indicates a high level of stress. The internal consistency coefficient of the scale was calculated as 0.84. In this study, the Cronbach alpha internal consistency coefficient was found to be 0.75.
Measured: up to 5 weeks
Maslach Burnout Scale
The scale, consisting of 22 items and three sub-dimensions, is in the 5-point Likert type. The sub-dimensions of the scale are emotional exhaustion, depersonalization and personal achievement. Positive statements in the dimension of personal achievement are reverse coded. The high mean score of the emotional exhaustion and depersonalization sub-dimensions and low personal achievement mean scores indicate high burnout. The lowest score that can be obtained from the scale is 0 and the highest score is 88. The Cronhbach Alpha values of the scale were found to be 0.83 for emotional exhaustion, 0.65 for depersonalization and 0.72 for personal achievement.
Measured: up to 5 weeks
Life Satisfaction Scale
There are 5 items in the scale, and each item is arranged according to a 7-point answer system. A score between 5-35 can be obtained from the scale. Higher scores indicate higher life satisfaction. The Cronbach Alpha value of the scale is .88. In this study, the Cronbach Alpha coefficient was found to be .87.
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start15 Jun 2021
- Primary completion30 Aug 2021
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay KILINÇ, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317091
- Sponsor's protocol ID
- tulay24
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Si S Celi K A, Kilinc T. The effect of laughter yoga on perceived stress, burnout, and life satisfaction in nurses during the pandemic: A randomized controlled trial. Complement Ther Clin Pract. 2022 Nov;49:101637. doi: 10.1016/j.ctcp.2022.101637. Epub 2022 Jul 5.
PubMed 35810525
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Nurses' Perceived Stress Burnout and Life Satisfaction During the Pandemic Period: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05317091
- Acronym / sponsor ID
- tulay24
- Conditions
- Abdominal Surgery, Hypertension, Done Laughter Yoga Before, Epilepsy
- Keywords
- Pandemic, Nurse, Stress, Burnout, Life satisfaction, Laughter yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 7 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 study aimed to determine the effects of laughter yoga on the perceived stress, burnout and life satisfaction of nurses working actively during the pandemic period. A total of 120 nurses, determined by power analysis, were included in the randomized controlled study. The study included 2 groups. (A group of nurses who have active contact with patients diagnosed with or at risk of covid-19, group B: nurses who have active contact with patients diagnosed with or at risk of covid-19 and participate in laughter yoga practice. Laughter yoga; immune system antibodies and endorphin hormone. It has been proven by experimental studies that there is a connection between the two, that it has a healing effect, that it accelerates the circulatory system as an adverse effect to stress, and that it has a vasodilation effect in the vessels.
Detailed description
The study data were collected by the researchers using online systems with the snowball method due to the pandemic. The inclusion criteria of the study (not having undergone abdominal surgery in the last three months, not having uncontrolled hypertension, not having glaucoma, hernia, epilepsy, not having received a psychiatric diagnosis-treatment, not having received a diagnosis-treatment for sleep problems, having done laughter yoga before) The study consisted of 100 nurses who agreed to participate in the study. Introductory features form consisting of 13 questions, Maslach Burnout Scale and Life Satisfaction Scale, Perceived Stress Scale and life satisfaction scale were used to collect data. Research data were collected in 3 months. During the study, 9 people from the experimental group (8 people did not attend the sessions regularly, 1 person left voluntarily), 10 people from the control group (he left voluntarily) quit the study. Finally, the research was completed with 101 nurses, 51 of whom were in the experimental group and 50 in the control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Laughter yoga practice | Experimental | Other: Laughter yoga practicedLaughter yoga for nurses The experimental group was divided into three groups as 18-17-16 people. Sessions 1st group Monday-Thursday between 12:00-13:00; 2nd group Tuesday-Friday between 17:00-18:00; The third group was held on Wednesday Saturday between 20:00-21:00.laughter yoga for nurses-Deep breathing exercises Deep breathing exercises (5 minutes), Warm-up exercises (10 minutes) laughter yoga for nurses-Childish games Childish games (10 minutes), Laughter exercises (15 minutes). |
| Laughter yoga session parts-1 | Experimental | Other: Laughter yoga practicedDeep breathing exercises (5 minutes) Breathing is held for 4-5 seconds after deep inspiration. While the arms are brought to the normal position, exhale slowly and rhythmically. When expressing after deep inspiration, the lips can be pursed as if whistling or exhaled with laughter. |
| Laughter yoga session parts-2 | Experimental | Other: Laughter yoga practicedWarm-up exercises (10 minutes) Rhythm of 1-2, 1-2-3 is added to increase the energy level even more and synchronize the movements of the group. After a few rhythmic clapping movements, another movement is added. Whisking hands left and right. Then an audible rhythm of ho, ho, ha-ha-ha is added to the clapping gesture. Make eye contact with people in the group and smile at them. |
| Laughter yoga session parts-3 | Experimental | Other: Laughter yoga practicedChildish games (10 minutes) Childlike games are used to help laugh without reason just like a child. The group is motivated by visualizing these games in their minds, raising the arms up in the form of a "Y" letter, and saying "very good (applause), very good (applause), hey" with palms facing the sky. |
| Laughter yoga session parts-4 | Experimental | Other: Laughter yoga practicedLaughter exercises (15 minutes) This section includes a variety of laughter exercises such as greetings, strawberry milk, conductor, bonus, hot soup, lion, aloha, bird, appreciation, laughter lotion, elevator, cream cake, and bursting balloon laughter. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not have undergone abdominal surgery in the past three months
- Uncontrollable hypertension
- Without epilepsy
Key exclusion criteria (2 listed)
- Antidepressant etc. nurses using drugs
- Not attending sessions regularly
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 |
|---|---|---|
| Laughter yoga practicedIn this study, 8 sessions of laughter yoga were applied to the nurses in the experimental group as an intervention, twice a week for 4 weeks. Due to the Covid-19 pandemic; Laughter Yoga sessions were held on the web through the 'ZOOM' program. For this reason, it is recommended that the laughter yoga sessions be done with a group and that the group should consist of at least five people in order to provide group dynamics. Sessions are planned according to the days and hours that nurses can attend. Sessions 1st group Monday-Thursday between 12:00-13:00; 2nd group Tuesday-Friday between 17:00-18:00; The third group was held on Wednesday-Saturday between 20:00-21:00. The nurses were constantly contacted (whatsapp, phone) to ensure that they attend the sessions regularly and that there is no interruption in the sessions. No experiment was performed on the control group during the study. However, after the research, a 4-week laughter yoga was given to the nurses who wanted it. | Other | Laughter yoga practice, Laughter yoga session parts-1, Laughter yoga session parts-2, Laughter yoga session parts-3, Laughter yoga session parts-4 |
Primary outcome
Introductory Information Form (questionnaire)
Time frame: up to 2 weeks
In this form prepared by the researchers; There are a total of 9 questions including age, gender, education level, marital status, working year, frequently worked shift, Covid-19 passing and being vaccinated, whether or not he has knowledge about laughter yoga.
Perceived Stress Scale
Time frame: up to 5 weeks]
The scale, which was created in order to understand how stressful individuals perceive certain events they experience, consists of 14 items, graded in a 5-point Likert type. In the scale, 7 items containing positive statements are reverse scored. The score range of the scale ranges from 0 to 56, and a high score indicates a high level of stress. The internal consistency coefficient of the scale was calculated as 0.84. In this study, the Cronbach alpha internal consistency coefficient was found to be 0.75.
Maslach Burnout Scale
Time frame: up to 5 weeks
The scale, consisting of 22 items and three sub-dimensions, is in the 5-point Likert type. The sub-dimensions of the scale are emotional exhaustion, depersonalization and personal achievement. Positive statements in the dimension of personal achievement are reverse coded. The high mean score of the emotional exhaustion and depersonalization sub-dimensions and low personal achievement mean scores indicate high burnout. The lowest score that can be obtained from the scale is 0 and the highest score is 88. The Cronhbach Alpha values of the scale were found to be 0.83 for emotional exhaustion, 0.65 for depersonalization and 0.72 for personal achievement.
Life Satisfaction Scale
Time frame: up to 5 weeks
There are 5 items in the scale, and each item is arranged according to a 7-point answer system. A score between 5-35 can be obtained from the scale. Higher scores indicate higher life satisfaction. The Cronbach Alpha value of the scale is .88. In this study, the Cronbach Alpha coefficient was found to be .87.
3 secondary outcomes
Perceived Stress Scale
Time frame: up to 5 weeks
Maslach Burnout Scale
Time frame: up to 5 weeks
Life Satisfaction Scale
Time frame: up to 5 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 7 Apr 2022.
- Derived from this study: PubMed 35810525Si S Celi K A, Kilinc T. The effect of laughter yoga on perceived stress, burnout, and life satisfaction in nurses during the pandemic: A randomized controlled trial. Complement Ther Clin Pract. 2022 Nov;49:101637. doi: 10.1016/j.ctcp.2022.101637. Epub 2022 Jul 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter yoga practiced in people with Abdominal Surgery and Hypertension, 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 3 inclusion and 2 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 7 Apr 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?
Introductory Information Form (questionnaire) (time frame: up to 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05317091, which also lists 1 linked publication.
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 7 Apr 2022.