LaughterNCT05807685
The Effect Of Laughter Therapy On Burnout And Guılt In Women
A study testing laughter therapy in people with Laughter and Burnout, run by Sinop University.
Trial summary
: Responsibility of women staying in their traditional and modern roles has increased and the difficulties experienced by women require them to struggle with many problems. As a result of these experiences, problems have arisen for women. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- What is being tested?
- laughter therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2023to 10 Aug 2023
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being the mother of the child studying at Sinop Atatürk Primary School where the research will be conducted, Having a burnout scale score of 3.5 and above, Volunteer to participate in research.
Who cannot join
- Not having a child studying at the Sinop Atatürk Primary School where the research will be conducted, Being the father of the child who was educated at the Sinop Atatürk Primary School, where the research will be conducted, Having a burnout scale score below 3.5, Not volunteering to participate in the research.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect Of Laughter Therapy On Burnout And Guılt In Women Wıth Chıldren In Prımary School
: Responsibility of women staying in their traditional and modern roles has increased and the difficulties experienced by women require them to struggle with many problems. As a result of these experiences, problems have arisen for women. In addition to the intensity of the home/work life of women who have children in primary school, the lesson and responsibility of the child falls on the women. In a patriarchal society, burdening all non-working women with the responsibility of their child in addition to housework increases the fatigue of mothers. Due to this intensity, they are not able to spare time for themselves and feel guilty. In women, this situation gradually causes burnout syndrome. One of the most important personal development methods used to reduce burnout is laughter therapy. The aim of this study is to apply laughter therapy in order to reduce this sense of burnout and guilt in women.
Aim: In this study, it was aimed to examine the effect of laughter therapy on the feelings of burnout and guilt of women who have children at primary school age.
Read the detailed description
Detailed Description: Method: The research is a randomized controlled experimental study.
The research will be carried out with the mothers of the students studying at Sinop Atatürk Primary School in the 2022-2023 academic year.
Research Population and Sample: All of the mothers of the students studying at the determined Sinop Atatürk Primary School in the spring term of 2022-2023 will form the universe. The sample of the study will include all mothers of the students studying at Sinop Atatürk Primary School in the 2022-2023 academic spring term, who meet the inclusion criteria, have a burnout scale score of 3.5 and above, and volunteer to participate in the research.
Arm Title: Control Group: At the beginning of the study, Data collection tools such as Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be applied to the control group.
No intervention will be made in the control group. In the post-test, the Expressed Guilt Scale and the Burnout Scale Short Version will be administered again.
Arm Title: Experimental Group: Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be administered to the mothers of children studying at Sinop Atatürk Primary School in the 2022-2023 spring semester before the laughter therapy. At the end of the laughter therapy, the Expressed Guilt Scale and the Short Version of the Burnout Scale will be administered as a post-test.
The Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be used for all mothers of the students studying in Atatürk Primary School in the 2022-2023 academic year. All women whose Burnout Scale Short Form is above the average will be included in the study. Since all women whose Burnout Scale Short Form is above the average, who volunteered to participate in the study and who met the inclusion criteria will be included in the study, no additional sample selection will be made. The application and control group will be determined on random.org among the group that constitutes the sample of the study. A 30-minute laughter therapy session will be applied to the application group once a week for 2 months. At the end of two months, the Expressed Guilt Scale and the Short Version of the Burnout Scale will be administered to both the application group and the control group.
- Being tested
- laughter therapy
- Keywords
- laughter therapy, burnout, guilt, women
- Medical subject headings
- Laughter, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter therapyBehavioural
Description: Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researchers who has the Laughter therapy certificate to the application group. In the laughter therapy session, the practices of introducing the practitioner and introducing the therapy, breathing exercises for a healthy life, keeping the rhythm accompanied by music, turning the laughter that started as if it were childlike games into reality will be carried out.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | At the beginning of the study, Data collection tools such as Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be applied to the control group. No intervention will be made in the control group. In the post-test, the Expressed Guilt Scale and the Burnout Scale Short Version will be administered again. |
| experimental group | Experimental | Arm Title: Experimental Group: Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be administered to the mothers of children studying at Sinop Atatürk Primary School in the 2022-2023 spring semester before the laughter therapy. At the end of the laughter therapy, the Expressed Guilt Scale and the Short Version of the Burnout Scale will be administered as a post-test.
The Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be used for all mothers of the students studying in Atatürk Primary School in the 2022-2023 academic year. All women whose Burnout Scale Short Form is above the average will be included in the study. Since all women whose Burnout Scale Short Form is above the average, who volunteered to participate in the study and who met the inclusion criteria will be included in the study, no additional sample selection will be made. Receives: Behavioral: laughter therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expressed Guilt Scale
The scale developed by Guerrero et al. (2009) consists of 20 items. Participants were asked to rate the extent to which each item reflected their feelings and thoughts in their relationships on a 7-point Likert scale (1 = never, 4 = sometimes, 7 = always/continuously). 4 of the items are to apologize/confess (e.g., "I tell my partner that I regret what I did (or did not do)"), 4 of them are to explain/give reason (e.g., "I tell my partner the reasons/reasons for what I did"), 7 of them measure compromising/forgiveness (eg, "I promise to be a better wife in the future") and 5 denial (eg, "I try to minimize/downplay the situation") sub-dimensions.
Measured: one day
Secondary outcomes (1)
Burnout Scale Short Form
The Burnout Scale Short Version consists of 10 items with response options ranging from 1 (Never) to 7 (Always). In the factor analysis study, it was shown that the items were collected in three factors explaining 64.8% of the total variance, but the tool could be evaluated as one-dimensional. It has been observed that those who score high on the scale report more complaints such as chronic fatigue, headaches and backaches than those with low scores, and they have low job satisfaction and low performance expectations. Original Burnout Scale Short Version scores are negatively associated with life satisfaction, general optimism, and job satisfaction. It also showed positive associations with somatic disorder, general work stress, and various specific work stressors.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start10 Apr 2023 (estimated)
- Primary completion10 Jun 2023 (estimated)
- Study completion10 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaughterStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna ERSOY ÖZCAN, Principal investigator, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807685
- Sponsor's protocol ID
- sinopUberna-1
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Laughter Therapy On Burnout And Guılt In Women Wıth Chıldren In Prımary School
- ClinicalTrials.gov ID
- NCT05807685
- Acronym / sponsor ID
- sinopUberna-1
- Keywords
- laughter therapy, burnout, guilt, women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (estimated)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 10 Aug 2023 (estimated)
- First posted
- 11 Apr 2023 (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.
: Responsibility of women staying in their traditional and modern roles has increased and the difficulties experienced by women require them to struggle with many problems. As a result of these experiences, problems have arisen for women. In addition to the intensity of the home/work life of women who have children in primary school, the lesson and responsibility of the child falls on the women. In a patriarchal society, burdening all non-working women with the responsibility of their child in addition to housework increases the fatigue of mothers. Due to this intensity, they are not able to spare time for themselves and feel guilty. In women, this situation gradually causes burnout syndrome. One of the most important personal development methods used to reduce burnout is laughter therapy. The aim of this study is to apply laughter therapy in order to reduce this sense of burnout and guilt in women.
Aim: In this study, it was aimed to examine the effect of laughter therapy on the feelings of burnout and guilt of women who have children at primary school age.
Detailed description
Detailed Description: Method: The research is a randomized controlled experimental study.
The research will be carried out with the mothers of the students studying at Sinop Atatürk Primary School in the 2022-2023 academic year.
Research Population and Sample: All of the mothers of the students studying at the determined Sinop Atatürk Primary School in the spring term of 2022-2023 will form the universe. The sample of the study will include all mothers of the students studying at Sinop Atatürk Primary School in the 2022-2023 academic spring term, who meet the inclusion criteria, have a burnout scale score of 3.5 and above, and volunteer to participate in the research.
Arm Title: Control Group: At the beginning of the study, Data collection tools such as Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be applied to the control group.
No intervention will be made in the control group. In the post-test, the Expressed Guilt Scale and the Burnout Scale Short Version will be administered again.
Arm Title: Experimental Group: Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be administered to the mothers of children studying at Sinop Atatürk Primary School in the 2022-2023 spring semester before the laughter therapy. At the end of the laughter therapy, the Expressed Guilt Scale and the Short Version of the Burnout Scale will be administered as a post-test.
The Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be used for all mothers of the students studying in Atatürk Primary School in the 2022-2023 academic year. All women whose Burnout Scale Short Form is above the average will be included in the study. Since all women whose Burnout Scale Short Form is above the average, who volunteered to participate in the study and who met the inclusion criteria will be included in the study, no additional sample selection will be made. The application and control group will be determined on random.org among the group that constitutes the sample of the study. A 30-minute laughter therapy session will be applied to the application group once a week for 2 months. At the end of two months, the Expressed Guilt Scale and the Short Version of the Burnout Scale will be administered to both the application group and the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –At the beginning of the study, Data collection tools such as Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be applied to the control group. No intervention will be made in the control group. In the post-test, the Expressed Guilt Scale and the Burnout Scale Short Version will be administered again. |
| experimental group | Experimental | Behavioral: laughter therapyArm Title: Experimental Group: Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be administered to the mothers of children studying at Sinop Atatürk Primary School in the 2022-2023 spring semester before the laughter therapy. At the end of the laughter therapy, the Expressed Guilt Scale and the Short Version of the Burnout Scale will be administered as a post-test. The Individual Identification Form, Expressed Guilt Scale and Burnout Scale Short Version will be used for all mothers of the students studying in Atatürk Primary School in the 2022-2023 academic year. All women whose Burnout Scale Short Form is above the average will be included in the study. Since all women whose Burnout Scale Short Form is above the average, who volunteered to participate in the study and who met the inclusion criteria will be included in the study, no additional sample selection will be made. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being the mother of the child studying at Sinop Atatürk Primary School where the research will be conducted, Having a burnout scale score of 3.5 and above, Volunteer to participate in research.
Key exclusion criteria (1 listed)
- Not having a child studying at the Sinop Atatürk Primary School where the research will be conducted, Being the father of the child who was educated at the Sinop Atatürk Primary School, where the research will be conducted, Having a burnout scale score below 3.5, Not volunteering to participate in the research.
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 therapyDescription: Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researchers who has the Laughter therapy certificate to the application group. In the laughter therapy session, the practices of introducing the practitioner and introducing the therapy, breathing exercises for a healthy life, keeping the rhythm accompanied by music, turning the laughter that started as if it were childlike games into reality will be carried out. | Behavioural | experimental group |
Primary outcome
Expressed Guilt Scale
Time frame: one day
The scale developed by Guerrero et al. (2009) consists of 20 items. Participants were asked to rate the extent to which each item reflected their feelings and thoughts in their relationships on a 7-point Likert scale (1 = never, 4 = sometimes, 7 = always/continuously). 4 of the items are to apologize/confess (e.g., "I tell my partner that I regret what I did (or did not do)"), 4 of them are to explain/give reason (e.g., "I tell my partner the reasons/reasons for what I did"), 7 of them measure compromising/forgiveness (eg, "I promise to be a better wife in the future") and 5 denial (eg, "I try to minimize/downplay the situation") sub-dimensions.
1 secondary outcome
Burnout Scale Short Form
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Berna ERSOY ÖZCAN principal investigator
Sinop University
Questions about this trial
What is this clinical trial studying?
A study testing laughter therapy in people with Laughter and Burnout, run by Sinop University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berna ERSOY ÖZCAN, PhD (+905363816797, bernaersoyozcan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expressed Guilt Scale (time frame: one day). 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 11 Apr 2023.