Laughter YogaNCT06995248
The Effect of Laughter Yoga on Pain, Fatigue, and General Well-Being in Cancer Patients and Their Caregivers
A study testing Laughter Yoga in people with Laughter Yoga, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of laughter yoga on pain, fatigue, and general well-being in cancer patients and their caregivers. Participants will be randomly assigned to either a laughter yoga intervention group or a control group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laughter Yoga
- 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
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Individuals who volunteer to participate in the study
Who cannot join
- having asthma or COPD
- being under 18 or over 65 years of age, and having any health condition or disability that impairs communication (such as visual or hearing impairments, or neurological or psychiatric disorders).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara
Özlem Bulantekin Düzalan, +905063801930, ozlembulantekin@gmail.com
About this study
Official title: Effect of Laughter Yoga on Pain, Fatigue and General Well-Being in Cancer Patients and Their Caregivers: A Randomized Controlled Study
This study aims to evaluate the effect of laughter yoga on pain, fatigue, and general well-being in cancer patients and their caregivers. Participants will be randomly assigned to either a laughter yoga intervention group or a control group. The intervention group will receive six sessions of laughter yoga over two weeks. Outcomes will be measured before and after the intervention.
Read the detailed description
Laughter yoga is a complementary mind-body practice that combines unconditional laughter with breathing techniques. It has been shown to reduce stress, improve mood, and promote psychological and physiological well-being. This randomized controlled trial will assess the effectiveness of a 6-session laughter yoga program on reducing pain and fatigue and enhancing general well-being in cancer patients and their caregivers. Participants in the experimental group will attend three sessions per week for two weeks, each lasting approximately 30-40 minutes. Outcomes will be measured before and after the intervention using validated scales.
Pain will be assessed using the Visual Analog Scale (VAS), which measures pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).
Fatigue will be measured using the Visual Analogue Scale for Fatigue (VAS-F), a validated instrument that evaluates the intensity of fatigue and its impact on daily activities.
The General Well-Being Scale is a self-report instrument used to assess an individual's overall psychological well-being.he scale includes items related to mood, emotional state, and general life satisfaction. It is typically measured using a Likert-type format, where participants rate the frequency and intensity of their feelings or experiences on a scale (e.g., from "strongly disagree" to "strongly agree").
These validated scales will be administered at baseline (before the intervention) and at the end of the intervention (after the 6 sessions) to assess changes in the primary outcomes of pain, fatigue, and general well-being.
- Conditions
- Laughter Yoga
- Being tested
- Laughter Yoga
- Keywords
- pain, caregives, fatigue, laughter therapy, cancer patients
- Medical subject headings
- Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter YogaBehavioural
Laughter yoga sessions are a behavioral intervention regularly conducted to help participants reduce stress, build social connections, and enhance overall well-being.
| Study group | Role | What they receive |
|---|---|---|
| Laughter Yoga Group | Experimental | Participants in this group will receive a 6-session laughter yoga program over a 2-week period. Each session includes breathing exercises, intentional laughter practices, and light physical activity. The intervention is designed to reduce stress, enhance well-being, and improve pain and fatigue levels. Receives: Behavioral: Laughter Yoga |
| control arm | No intervention | Participants in this group will not receive any behavioral intervention during the study period. They will only complete the pre- and post-assessment questionnaires at the same intervals as the experimental group, allowing for outcome comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Level
Pain will be measured using the Visual Analog Scale (VAS) at baseline and one week after the final session to assess the effectiveness of the intervention.
Measured: Before and one week after the 6-session laughter yoga program
Secondary outcomes (1)
Change in Fatigue Level
Change in fatigue level measured by the Visual Similarity Scale for Fatigue
Measured: Before the intervention and one week after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start5 May 2025
- Primary completion2 Sep 2025 (estimated)
- Study completion10 Feb 2026 (estimated)
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 Laughter YogaStudies 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birim Kiper, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995248
- Sponsor's protocol ID
- 0009000956254142
- Status last verified
- May 2025
- First submitted
- 10 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morishima T, Miyashiro I, Inoue N, Kitasaka M, Akazawa T, Higeno A, Idota A, Sato A, Ohira T, Sakon M, Matsuura N. Effects of laughter therapy on quality of life in patients with cancer: An open-label, randomized controlled trial. PLoS One. 2019 Jun 27;14(6):e0219065. doi: 10.1371/journal.pone.0219065. eCollection 2019.
PubMed 31247017
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laughter Yoga on Pain, Fatigue and General Well-Being in Cancer Patients and Their Caregivers: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06995248
- Acronym / sponsor ID
- 0009000956254142
- Conditions
- Laughter Yoga
- Keywords
- pain, caregives, fatigue, laughter therapy, cancer patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 29 May 2025 (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 aims to evaluate the effect of laughter yoga on pain, fatigue, and general well-being in cancer patients and their caregivers. Participants will be randomly assigned to either a laughter yoga intervention group or a control group. The intervention group will receive six sessions of laughter yoga over two weeks. Outcomes will be measured before and after the intervention.
Detailed description
Laughter yoga is a complementary mind-body practice that combines unconditional laughter with breathing techniques. It has been shown to reduce stress, improve mood, and promote psychological and physiological well-being. This randomized controlled trial will assess the effectiveness of a 6-session laughter yoga program on reducing pain and fatigue and enhancing general well-being in cancer patients and their caregivers. Participants in the experimental group will attend three sessions per week for two weeks, each lasting approximately 30-40 minutes. Outcomes will be measured before and after the intervention using validated scales.
Pain will be assessed using the Visual Analog Scale (VAS), which measures pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).
Fatigue will be measured using the Visual Analogue Scale for Fatigue (VAS-F), a validated instrument that evaluates the intensity of fatigue and its impact on daily activities.
The General Well-Being Scale is a self-report instrument used to assess an individual's overall psychological well-being.he scale includes items related to mood, emotional state, and general life satisfaction. It is typically measured using a Likert-type format, where participants rate the frequency and intensity of their feelings or experiences on a scale (e.g., from "strongly disagree" to "strongly agree").
These validated scales will be administered at baseline (before the intervention) and at the end of the intervention (after the 6 sessions) to assess changes in the primary outcomes of pain, fatigue, and general well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter Yoga Group | Experimental | Behavioral: Laughter YogaParticipants in this group will receive a 6-session laughter yoga program over a 2-week period. Each session includes breathing exercises, intentional laughter practices, and light physical activity. The intervention is designed to reduce stress, enhance well-being, and improve pain and fatigue levels. |
| control arm | No intervention | –Participants in this group will not receive any behavioral intervention during the study period. They will only complete the pre- and post-assessment questionnaires at the same intervals as the experimental group, allowing for outcome comparison. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who volunteer to participate in the study
Key exclusion criteria (2 listed)
- having asthma or COPD
- being under 18 or over 65 years of age, and having any health condition or disability that impairs communication (such as visual or hearing impairments, or neurological or psychiatric disorders).
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 YogaLaughter yoga sessions are a behavioral intervention regularly conducted to help participants reduce stress, build social connections, and enhance overall well-being. | Behavioural | Laughter Yoga Group |
Primary outcome
Change in Pain Level
Time frame: Before and one week after the 6-session laughter yoga program
Pain will be measured using the Visual Analog Scale (VAS) at baseline and one week after the final session to assess the effectiveness of the intervention.
1 secondary outcome
Change in Fatigue Level
Time frame: Before the intervention and one week after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Background: PubMed 31247017Morishima T, Miyashiro I, Inoue N, Kitasaka M, Akazawa T, Higeno A, Idota A, Sato A, Ohira T, Sakon M, Matsuura N. Effects of laughter therapy on quality of life in patients with cancer: An open-label, randomized controlled trial. PLoS One. 2019 Jun 27;14(6):e0219065. doi: 10.1371/journal.pone.0219065. eCollection 2019.
- 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.
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 Yoga, run by Çankırı Karatekin 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 1 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: looking for participants now, as of the sponsor's last update on 29 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birim Kiper (+90 543 680 4252, brmkpr88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Level (time frame: Before and one week after the 6-session laughter yoga program). 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 NCT06995248, 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 29 May 2025.