LaughterNCT05843058
The Effect of Laughter Yoga on Psychological Wellness
A study testing laughter yoga in people with Laughter and Gynecologic Cancer, run by Istanbul Gedik University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the thesis is to determine the effect of laughter yoga on psychological well-being in women diagnosed with Gynecological Cancer.The population of the study consists of the patients registered in the oncology service of Tepecik Training and Research Hospital in Izmir. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Laughter, Gynecologic Cancer, Psychological
- What is being tested?
- laughter yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Apr 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Volunteering to participate in the study
- Having the ability to read, write, speak and understand Turkish
- Being diagnosed with gynecological cancer
- Being in Stage II or Stage III of the gynecological cancer staging processes
- The patient's internet access
Who cannot join
- The patient is Stage 4
- Lack of internet access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laughter Yoga on Psychological Wellness on Women With Gynecological Cancer
The aim of the thesis is to determine the effect of laughter yoga on psychological well-being in women diagnosed with Gynecological Cancer.The population of the study consists of the patients registered in the oncology service of Tepecik Training and Research Hospital in Izmir. The study was carried out with 70 patients, 35 of which were interventions and 35 controls, who were treated in the oncology service of Izmir Tepecik Training and Research Hospital.
Read the detailed description
The aim of the thesis is to determine the effect of laughter yoga on psychological well-being in women diagnosed with Gynecological Cancer.The population of the study consists of the patients registered in the oncology service of Tepecik Training and Research Hospital in Izmir. The study was carried out with 70 patients, 35 of which were interventions and 35 controls, who were treated in the oncology service of Izmir Tepecik Training and Research Hospital between October 1, 2021 and April 1, 2022. In order to measure the effect of laughter yoga on psychological well-being, the Psychological Well-Being Scale was applied to both the experimental group and the control group patients.
- Conditions
- Laughter, Gynecologic Cancer, Psychological
- Being tested
- laughter yoga
- Medical subject headings
- Laughter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter yogaBehavioural
The effect of laughter yoga on psychologıcal wellness ın women wıth gynecologıcal cancer has been evaluated.
| Study group | Role | What they receive |
|---|---|---|
| laughter yoga | Experimental | The psychological well-being scale was filled in at the first encounter with the patient. Then, 12 sessions of laughter yoga were performed and after 12 sessions, the psychological well-being scale was applied again.(Laughter yoga was practiced twice a week for 6 weeks) Receives: Behavioral: laughter yoga |
| Standard care | No intervention | The psychological well-being scale was filled in at the first encounter with the patient. Then, 6 weeks later, the psychological well-being scale was applied again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychological well-being scale (PWS)
Change in Psychological well-being scale (PWS); is a 7-point Likert type scale ranging from strongly disagree (1) to strongly agree (7). All items are expressed positively. The lowest score is 8 and the highest score is 56. A high score indicates that the individual has many psychological resources and strengths.
The effect of laughter yoga on psychologıcal wellness.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Oct 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gedik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kerime derya beydağ, Istanbul Gedik University
- Investigators
- Kerime Derya BEYDAG, Study director, https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843058
- Sponsor's protocol ID
- DBEYDAG002*
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett PN, Hussein WF, Reiterman M, Yu J, Schiller B. The effects of laughter therapy on depression symptoms in patients undergoing center hemodialysis: A pragmatic randomized controlled trial. Hemodial Int. 2020 Oct;24(4):541-549. doi: 10.1111/hdi.12870. Epub 2020 Aug 25.
PubMed 32844575Cho EA, Oh HE. [Effects of laughter therapy on depression, quality of life, resilience and immune responses in breast cancer survivors]. J Korean Acad Nurs. 2011 Jun;41(3):285-93. doi: 10.4040/jkan.2011.41.3.285. Korean.
PubMed 21804337Demir Dogan M. The Effect of Laughter Therapy on Anxiety: A Meta-analysis. Holist Nurs Pract. 2020 Jan/Feb;34(1):35-39. doi: 10.1097/HNP.0000000000000363.
PubMed 31725098Ghodsbin F, Sharif Ahmadi Z, Jahanbin I, Sharif F. The effects of laughter therapy on general health of elderly people referring to jahandidegan community center in shiraz, iran, 2014: a randomized controlled trial. Int J Community Based Nurs Midwifery. 2015 Jan;3(1):31-8.
PubMed 25553332Hatzipapas I, Visser MJ, Janse van Rensburg E. Laughter therapy as an intervention to promote psychological well-being of volunteer community care workers working with HIV-affected families. SAHARA J. 2017 Dec;14(1):202-212. doi: 10.1080/17290376.2017.1402696.
PubMed 29169302Kim SH, Kim YH, Kim HJ. Laughter and Stress Relief in Cancer Patients: A Pilot Study. Evid Based Complement Alternat Med. 2015;2015:864739. doi: 10.1155/2015/864739. Epub 2015 May 24.
PubMed 26064177
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Psychological Wellness on Women With Gynecological Cancer
- ClinicalTrials.gov ID
- NCT05843058
- Acronym / sponsor ID
- DBEYDAG002*
- Conditions
- Laughter, Gynecologic Cancer, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul Gedik UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 6 May 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.
The aim of the thesis is to determine the effect of laughter yoga on psychological well-being in women diagnosed with Gynecological Cancer.The population of the study consists of the patients registered in the oncology service of Tepecik Training and Research Hospital in Izmir. The study was carried out with 70 patients, 35 of which were interventions and 35 controls, who were treated in the oncology service of Izmir Tepecik Training and Research Hospital.
Detailed description
The aim of the thesis is to determine the effect of laughter yoga on psychological well-being in women diagnosed with Gynecological Cancer.The population of the study consists of the patients registered in the oncology service of Tepecik Training and Research Hospital in Izmir. The study was carried out with 70 patients, 35 of which were interventions and 35 controls, who were treated in the oncology service of Izmir Tepecik Training and Research Hospital between October 1, 2021 and April 1, 2022. In order to measure the effect of laughter yoga on psychological well-being, the Psychological Well-Being Scale was applied to both the experimental group and the control group patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laughter yoga | Experimental | Behavioral: laughter yogaThe psychological well-being scale was filled in at the first encounter with the patient. Then, 12 sessions of laughter yoga were performed and after 12 sessions, the psychological well-being scale was applied again.(Laughter yoga was practiced twice a week for 6 weeks) |
| Standard care | No intervention | –The psychological well-being scale was filled in at the first encounter with the patient. Then, 6 weeks later, the psychological well-being scale was applied again. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Volunteering to participate in the study
Key exclusion criteria (2 listed)
- The patient is Stage 4
- Lack of internet access
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 yogaThe effect of laughter yoga on psychologıcal wellness ın women wıth gynecologıcal cancer has been evaluated. | Behavioural | laughter yoga |
Primary outcome
Change in Psychological well-being scale (PWS)
Time frame: 6 months
Change in Psychological well-being scale (PWS); is a 7-point Likert type scale ranging from strongly disagree (1) to strongly agree (7). All items are expressed positively. The lowest score is 8 and the highest score is 56. A high score indicates that the individual has many psychological resources and strengths. The effect of laughter yoga on psychologıcal wellness.
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 6 May 2023.
- Background: PubMed 32844575Bennett PN, Hussein WF, Reiterman M, Yu J, Schiller B. The effects of laughter therapy on depression symptoms in patients undergoing center hemodialysis: A pragmatic randomized controlled trial. Hemodial Int. 2020 Oct;24(4):541-549. doi: 10.1111/hdi.12870. Epub 2020 Aug 25.
- Background: PubMed 21804337Cho EA, Oh HE. [Effects of laughter therapy on depression, quality of life, resilience and immune responses in breast cancer survivors]. J Korean Acad Nurs. 2011 Jun;41(3):285-93. doi: 10.4040/jkan.2011.41.3.285. Korean.
- Background: PubMed 31725098Demir Dogan M. The Effect of Laughter Therapy on Anxiety: A Meta-analysis. Holist Nurs Pract. 2020 Jan/Feb;34(1):35-39. doi: 10.1097/HNP.0000000000000363.
- Background: PubMed 25553332Ghodsbin F, Sharif Ahmadi Z, Jahanbin I, Sharif F. The effects of laughter therapy on general health of elderly people referring to jahandidegan community center in shiraz, iran, 2014: a randomized controlled trial. Int J Community Based Nurs Midwifery. 2015 Jan;3(1):31-8.
- Background: PubMed 29169302Hatzipapas I, Visser MJ, Janse van Rensburg E. Laughter therapy as an intervention to promote psychological well-being of volunteer community care workers working with HIV-affected families. SAHARA J. 2017 Dec;14(1):202-212. doi: 10.1080/17290376.2017.1402696.
- Background: PubMed 26064177Kim SH, Kim YH, Kim HJ. Laughter and Stress Relief in Cancer Patients: A Pilot Study. Evid Based Complement Alternat Med. 2015;2015:864739. doi: 10.1155/2015/864739. Epub 2015 May 24.
- 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.
Kerime Derya BEYDAG study director
https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp
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 in people with Laughter and Gynecologic Cancer, run by Istanbul Gedik 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 5 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 6 May 2023. 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?
Change in Psychological well-being scale (PWS) (time frame: 6 months). 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 NCT05843058, which also lists 6 linked publications.
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 6 May 2023.