LaughterNCT05807698
The Effect of Laughter Yoga on Psychological Well-Being
A study testing laughter therapy in people with Laughter and Quality of Life, run by Sinop University.
Trial summary
Brief Summary: The definition of individuals with disabilities, who are among the disadvantaged group, is defined by Law No. 5378 as "those who have difficulties in adapting to social life and meeting their daily needs due to the loss of their physical, mental, spiritual, sensory and social abilities at various… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laughter, Quality of Life
- 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
- 20 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65,
- Being woman,
- Not being mentally handicapped
- Having a physical disability
- Being a relative caring for a woman with a physical disability.
Who cannot join
- Not being between the ages of 18-65,
- To being male,
- Being mentally handicapped
- Not having a physical disability
- 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 Yoga on Psychological Well-Being and Quality of Life in Physically Disabled Women and Their Relatives
Brief Summary: The definition of individuals with disabilities, who are among the disadvantaged group, is defined by Law No. 5378 as "those who have difficulties in adapting to social life and meeting their daily needs due to the loss of their physical, mental, spiritual, sensory and social abilities at various degrees due to any congenital or subsequent reason; and a person who needs protection, care, rehabilitation, counseling and support services" (Law on the Disabled).
Due to the fact that the conditions and needs of physically disabled women are not well expressed, they have not benefited enough from services such as education and health and they have faced difficulties. No study has been found in the world or in our country that examines the effect of laughter yoga on physically disabled women and their relatives. In this study, it is thought that the practice of laughter yoga can increase the psychological well-being and quality of life of physically disabled women and their relatives.
Aim: This study was planned to measure the effect of laughter yoga on psychological well-being and quality of life in physically disabled women and their relatives.
Read the detailed description
Detailed Description: Method: The research was planned as a quasi-experimental study including pre-test, post-test and follow-up.
The research will be carried out by reaching physically disabled women and their relatives affiliated to Sinop Disabled Association.
Population and Sample: Disabled women living and their relatives in Sinop in the Sinop Disabled Association will form the universe of our study, and all individuals who have agreed to participate in the study and volunteered will form the sample.
How the research was conducted: Laughter yoga to be done will last eight weeks, once a week. Each session of laughter yoga is planned to be approximately 40 minutes. Personal Information Form, Psychological Well-Being Scale, SF-12 Quality of Life Scale Short Form, Psychological Well-Being Scale and SF-12 Quality of Life Scale as a post-test at the end of the laughter yoga were used for the physically disabled women and their relatives who agreed to participate in the study before starting the study. The Short Form and the Psychological Well-Being Scale and the SF-12 Quality of Life Scale Short Form will be administered again in the follow-up (one month after the application has ended).
- Conditions
- Laughter, Quality of Life
- Being tested
- laughter therapy
- Keywords
- laughter therapy, psychological well being, quality of life, Physically Disabled Women
- Medical subject headings
- Laughter, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter therapyBehavioural
Assigned Interventions Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researcher 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 |
|---|---|---|
| experimental | Experimental | Assigned Interventions Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researcher 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. Receives: Behavioral: laughter therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Well-Being Scale
It was developed by Diener et al., (2010) and adapted into Turkish by Telef (2013). It is a single factor, 7-point Likert scale consisting of 8 items. The range of scores obtained varies between 8 and 56. A high score from the scale indicates that the individual is psychologically strong.
Measured: one day
Secondary outcomes (1)
SF-12 Quality of Life Scale Short Form
The scale includes physical functioning (questions 2a, 2b, 2 and 3), physical role (questions 2, 3a, 3b, 4 and 5), body pain (1 item 5, 8th question), general health (1 item 1, 1st question), energy (1 item 6b, 10th question), social functionality (1 item, 7, 12th question), emotional role (2 items 4a 4b, 6 and 7th question) and mental health (2 items 6a, 6c, 9 and 11 items) and 8 sub-dimensions and 12 items. Items related to physical and emotional role were answered as dichotomy (yes or no), while other items had Likert type options ranging between 3 and 6. While the FIM-12 score is obtained from the sub-dimensions of general health, physical functionality, physical role and body pain, the MBS-12 score is obtained from the sub-dimensions of social functionality, emotional role, mental health and energy. Both FIM-12 and DRD-12 scores range from 0 to 100, with higher scores representing better health.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna ERSOY ÖZCAN, PhD, Principal investigator, Sinop UniversityYasemin ÖZYER, PhD, Principal investigator, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807698
- Sponsor's protocol ID
- sinopUberna-2
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2023
- Last updated
- 12 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Psychological Well-Being and Quality of Life in Physically Disabled Women and Their Relatives
- ClinicalTrials.gov ID
- NCT05807698
- Acronym / sponsor ID
- sinopUberna-2
- Conditions
- Laughter, Quality of Life
- Keywords
- laughter therapy, psychological well being, quality of life, Physically Disabled Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 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.
Brief Summary: The definition of individuals with disabilities, who are among the disadvantaged group, is defined by Law No. 5378 as "those who have difficulties in adapting to social life and meeting their daily needs due to the loss of their physical, mental, spiritual, sensory and social abilities at various degrees due to any congenital or subsequent reason; and a person who needs protection, care, rehabilitation, counseling and support services" (Law on the Disabled).
Due to the fact that the conditions and needs of physically disabled women are not well expressed, they have not benefited enough from services such as education and health and they have faced difficulties. No study has been found in the world or in our country that examines the effect of laughter yoga on physically disabled women and their relatives. In this study, it is thought that the practice of laughter yoga can increase the psychological well-being and quality of life of physically disabled women and their relatives.
Aim: This study was planned to measure the effect of laughter yoga on psychological well-being and quality of life in physically disabled women and their relatives.
Detailed description
Detailed Description: Method: The research was planned as a quasi-experimental study including pre-test, post-test and follow-up.
The research will be carried out by reaching physically disabled women and their relatives affiliated to Sinop Disabled Association.
Population and Sample: Disabled women living and their relatives in Sinop in the Sinop Disabled Association will form the universe of our study, and all individuals who have agreed to participate in the study and volunteered will form the sample.
How the research was conducted: Laughter yoga to be done will last eight weeks, once a week. Each session of laughter yoga is planned to be approximately 40 minutes. Personal Information Form, Psychological Well-Being Scale, SF-12 Quality of Life Scale Short Form, Psychological Well-Being Scale and SF-12 Quality of Life Scale as a post-test at the end of the laughter yoga were used for the physically disabled women and their relatives who agreed to participate in the study before starting the study. The Short Form and the Psychological Well-Being Scale and the SF-12 Quality of Life Scale Short Form will be administered again in the follow-up (one month after the application has ended).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: laughter therapyAssigned Interventions Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researcher 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between the ages of 18-65,
- Being woman,
- Not being mentally handicapped
- Having a physical disability
- Being a relative caring for a woman with a physical disability.
Key exclusion criteria (5 listed)
- Not being between the ages of 18-65,
- To being male,
- Being mentally handicapped
- Not having a physical disability
- 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 therapyAssigned Interventions Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researcher 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 |
Primary outcome
Psychological Well-Being Scale
Time frame: one day
It was developed by Diener et al., (2010) and adapted into Turkish by Telef (2013). It is a single factor, 7-point Likert scale consisting of 8 items. The range of scores obtained varies between 8 and 56. A high score from the scale indicates that the individual is psychologically strong.
1 secondary outcome
SF-12 Quality of Life 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 12 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, PhD principal investigator
Sinop University
Yasemin ÖZYER, PhD principal investigator
Sinop University
Questions about this trial
What is this clinical trial studying?
A study testing laughter therapy in people with Laughter and Quality of Life, 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 5 inclusion and 5 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 12 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 (05363816797, bernaersoyozcan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Well-Being 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 12 Apr 2023.