CancerNCT06654869
Effects of Laughter Yoga on Symptom Severity, Hope, and Life Engagement in Patients Undergoing Chemotherapy; A Randomized Controlled Study
A study testing lauhgter yoga in people with Cancer and Nurse's Role, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Non-pharmacological interventions that promote positive emotional states and coping may play a critical role in care of cancer patients undergoing chemotherapy.This study aimed to evaluate the effects of laughter yoga on symptoms, hope, and life engagement levels in cancer patients undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Nurse's Role, Quality of Life
- What is being tested?
- lauhgter yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2025to 15 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: (1) age ≥18, (2) pathologically confirmed cancer diagnosis, (3) be able to communicate, and (4) voluntary participation. Exclusion criteria: (1) diagnosed psychiatric disorders that may interfere with study participation or communication, (2) receiving medical treatments other than chemotherapy, (3) significant hearing or vision loss, (4) prior experience with laughter therapy, or (5) an unstable clinical condition. Discontinuation Criteria: (1) withdrawal request, (2) worsening of clinical condition, (3) change in treatment protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Non-pharmacological interventions that promote positive emotional states and coping may play a critical role in care of cancer patients undergoing chemotherapy.This study aimed to evaluate the effects of laughter yoga on symptoms, hope, and life engagement levels in cancer patients undergoing chemotherapy. Conducted between January and June 2025 at the chemotherapy unit of Atatürk University Research Hospital in Türkiye. . Sixty patients were randomized (30 per group). Five were excluded after randomization before baseline assessment because of changes in medical treatment, leaving 55 participants in the per-protocol analysis (intervention n= 27; control n= 28). Symptom severity, hope, and life engagement were measured at baseline and after four weeks using the Edmonton Symptom Assessment Scale (ESAS), Herth Hope Scale (HHS), and Life Engagement Scale (LES). Post-intervention analyses revealed statistically significant improvements in the intervention group compared to the control group. Patients who received laughter yoga reported significantly lower symptom severity on the ESAS (p < 0.05), along with significantly higher levels of hope and life engagement as measured by the HHS and LES, respectively (p < 0.05).
Read the detailed description
The sample size was determined through an a priori power analysis using G*Power software (version 3.1.2). The test family was "t tests" and the statistical test was "Means: Difference between two independent means (two groups)". Based on Cohen's standard effect size references it was determined that a total of 52 participants (26 per group) would be sufficient to achieve 80% power with a large effect size (two-tailed, Cohen's d = 0.80, α = 0.05). The choice of a large effect size was justified by recent evidence from laughter interventions in cancer. To account for a potential 15% attrition rate, 8 additional participants were included, resulting in a total sample size of 60 individuals. Following the completion of the study, the effect sizes for each variable were reported in their respective tables. Inclusion criteria: (1) age ≥18, (2) pathologically confirmed cancer diagnosis, (3) be able to communicate, and (4) voluntary participation. Exclusion criteria: (1) diagnosed psychiatric disorders that may interfere with study participation or communication, (2) receiving medical treatments other than chemotherapy, (3) significant hearing or vision loss, (4) prior experience with laughter therapy, or (5) an unstable clinical condition. Discontinuation Criteria: (1) withdrawal request, (2) worsening of clinical condition, (3) change in treatment protocol.
A list of eligible patients was provided by the unit charge nurse. Of the 87 assessed, 24 patients did not meet inclusion criteria and 3 patients declined participation. Due to the nature of the laughter yoga intervention, participants and the first author (who performed the sessions) could not be blinded. After obtaining voluntary consent, eligible patients were randomized into intervention (n=30) and control (n=30) groups with a 1:1 allocation ratio using a computer-generated random number list (randomizer.org). To ensure allocation concealment, randomization was managed by an independent researcher who did not recruit patients or perform the sessions. Once a patient was enrolled, the independent researcher provided the group assignment to the first researcher. This centralized approach prevented the first researcher from knowing the sequence in advance, thereby reducing potential selection bias. Immediately following randomization, but prior to the collection of pre-test and the commencement of the intervention, five patients (3 from the intervention group and 2 from the control group) were excluded due to unforeseen changes in their medical treatment protocols. Since these individuals left the study before any baseline or post-test assessments could be conducted, their data were unavailable for inclusion. Consequently, a per-protocol analysis was performed with the remaining 55 patients (27 intervention, 28 control) who completed the trial. To minimize bias, data analysis was conducted by an independent statistician who remained blinded to the group assignments throughout the study.
Explanation regarding protocol improvements: Initial registration reflected the study plan at the time of registration. Before enrollment of the first participant, certain methodological and operational details were further refined based on the clinical setting, characteristics of the appropriate patient population, discussions with the clinical team, and a review of the relevant literature. These refinements included a more detailed definition of the intervention duration, the randomization procedure, and the eligibility criteria. Final procedures were determined prior to the enrollment of the first participant on January 30, 2025, and were consistently applied throughout the study.
- Conditions
- Cancer, Nurse's Role, Quality of Life
- Being tested
- lauhgter yoga
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lauhgter yogaBehavioural
include laughter yoga effects on cancer patients' symptom management
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | No intervention | Not described |
| Arm 1 | Experimental | laughter yoga Receives: Behavioral: lauhgter yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edmonton Symptom Assesment Scale (ESAS)
The scale, originally developed by Bruera et al. (1991) to assess nine common symptoms in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. For this study, the Turkish version validated by Sadırlı and Ünsar (2009) was utilized, which includes three additional symptoms-changes in skin and nails, mouth sores, and numbness in the hands-resulting in a 12-item scale. Each symptom is rated on a numerical scale from 0 "symptom absent" to 10 "worst possible severity". In the Turkish validation study, Cronbach's alpha coefficients were reported as 0.83 for the pre-test and 0.76 for the post-test. In the present study, the Cronbach's alpha coefficients for the scale were calculated as 0.71 and 0.72 for the pre-test and post-test, respectively.
Measured: 4 weeks
Life Engagement Scale
The Life Engagement scale, developed by Scheier et al. (2006) to assess individuals' life goals and whose Turkish validity and reliability were determined by Akın et al., is a measurement tool consisting of 6 items and a single dimension (life engagement). The scale has a 5-point scale ("1" I completely disagree, "5" I completely agree). Items 1, 3 and 5 are reverse coded in the scale. Increasing scores indicate a high level of life engagement.
Measured: 4 weeks
Herth Hope Scale
The Herth Hope Scale was developed by Kaye Herth. The scale consists of 30 items. Each item has four options: "Never " "Rarely appropriate," "Sometimes" and "Always " . The corresponding scores are 0, 1, 2, and 3, respectively. The respondent is asked to mark a single option for each item. The scale consists of 3 sub-dimensions. These are "Future," "Positive Readiness and Expectation," and "Relationships Between Oneself and Those Around Oneself." The "Future" sub-dimension measures the cognitive-temporal dimension of hope, the "Positive Readiness and Expectation" sub-dimension measures the emotional-behavioral dimension of hope, and the "Relationships Between Oneself and Those Around Oneself" sub-dimension measures the dimension of hope related to relationships and the conditions in which it exists. The total hope score varies between 0-90, and the total score of each subscale varies between 0-30. High scores, It shows that hope is high.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start30 Jan 2025
- Primary completion30 Jun 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Ciraci Yasar, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654869
- Sponsor's protocol ID
- ATATURKU-NRS-YCY-02
- Status last verified
- Aug 2026
- First submitted
- 26 Sep 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laughter Yoga on Symptom Severity, Hope, and Life Engagement in Patients Undergoing Chemotherapy; A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06654869
- Acronym / sponsor ID
- ATATURKU-NRS-YCY-02
- Conditions
- Cancer, Nurse's Role, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 23 Oct 2024 (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.
Non-pharmacological interventions that promote positive emotional states and coping may play a critical role in care of cancer patients undergoing chemotherapy.This study aimed to evaluate the effects of laughter yoga on symptoms, hope, and life engagement levels in cancer patients undergoing chemotherapy. Conducted between January and June 2025 at the chemotherapy unit of Atatürk University Research Hospital in Türkiye. . Sixty patients were randomized (30 per group). Five were excluded after randomization before baseline assessment because of changes in medical treatment, leaving 55 participants in the per-protocol analysis (intervention n= 27; control n= 28). Symptom severity, hope, and life engagement were measured at baseline and after four weeks using the Edmonton Symptom Assessment Scale (ESAS), Herth Hope Scale (HHS), and Life Engagement Scale (LES). Post-intervention analyses revealed statistically significant improvements in the intervention group compared to the control group. Patients who received laughter yoga reported significantly lower symptom severity on the ESAS (p < 0.05), along with significantly higher levels of hope and life engagement as measured by the HHS and LES, respectively (p < 0.05).
Detailed description
The sample size was determined through an a priori power analysis using G*Power software (version 3.1.2). The test family was "t tests" and the statistical test was "Means: Difference between two independent means (two groups)". Based on Cohen's standard effect size references it was determined that a total of 52 participants (26 per group) would be sufficient to achieve 80% power with a large effect size (two-tailed, Cohen's d = 0.80, α = 0.05). The choice of a large effect size was justified by recent evidence from laughter interventions in cancer. To account for a potential 15% attrition rate, 8 additional participants were included, resulting in a total sample size of 60 individuals. Following the completion of the study, the effect sizes for each variable were reported in their respective tables. Inclusion criteria: (1) age ≥18, (2) pathologically confirmed cancer diagnosis, (3) be able to communicate, and (4) voluntary participation. Exclusion criteria: (1) diagnosed psychiatric disorders that may interfere with study participation or communication, (2) receiving medical treatments other than chemotherapy, (3) significant hearing or vision loss, (4) prior experience with laughter therapy, or (5) an unstable clinical condition. Discontinuation Criteria: (1) withdrawal request, (2) worsening of clinical condition, (3) change in treatment protocol.
A list of eligible patients was provided by the unit charge nurse. Of the 87 assessed, 24 patients did not meet inclusion criteria and 3 patients declined participation. Due to the nature of the laughter yoga intervention, participants and the first author (who performed the sessions) could not be blinded. After obtaining voluntary consent, eligible patients were randomized into intervention (n=30) and control (n=30) groups with a 1:1 allocation ratio using a computer-generated random number list (randomizer.org). To ensure allocation concealment, randomization was managed by an independent researcher who did not recruit patients or perform the sessions. Once a patient was enrolled, the independent researcher provided the group assignment to the first researcher. This centralized approach prevented the first researcher from knowing the sequence in advance, thereby reducing potential selection bias. Immediately following randomization, but prior to the collection of pre-test and the commencement of the intervention, five patients (3 from the intervention group and 2 from the control group) were excluded due to unforeseen changes in their medical treatment protocols. Since these individuals left the study before any baseline or post-test assessments could be conducted, their data were unavailable for inclusion. Consequently, a per-protocol analysis was performed with the remaining 55 patients (27 intervention, 28 control) who completed the trial. To minimize bias, data analysis was conducted by an independent statistician who remained blinded to the group assignments throughout the study.
Explanation regarding protocol improvements: Initial registration reflected the study plan at the time of registration. Before enrollment of the first participant, certain methodological and operational details were further refined based on the clinical setting, characteristics of the appropriate patient population, discussions with the clinical team, and a review of the relevant literature. These refinements included a more detailed definition of the intervention duration, the randomization procedure, and the eligibility criteria. Final procedures were determined prior to the enrollment of the first participant on January 30, 2025, and were consistently applied throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | No intervention | – |
| Arm 1 | Experimental | Behavioral: lauhgter yogalaughter yoga |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| lauhgter yogainclude laughter yoga effects on cancer patients' symptom management | Behavioural | Arm 1 |
Primary outcome
Edmonton Symptom Assesment Scale (ESAS)
Time frame: 4 weeks
The scale, originally developed by Bruera et al. (1991) to assess nine common symptoms in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. For this study, the Turkish version validated by Sadırlı and Ünsar (2009) was utilized, which includes three additional symptoms-changes in skin and nails, mouth sores, and numbness in the hands-resulting in a 12-item scale. Each symptom is rated on a numerical scale from 0 "symptom absent" to 10 "worst possible severity". In the Turkish validation study, Cronbach's alpha coefficients were reported as 0.83 for the pre-test and 0.76 for the post-test. In the present study, the Cronbach's alpha coefficients for the scale were calculated as 0.71 and 0.72 for the pre-test and post-test, respectively.
Life Engagement Scale
Time frame: 4 weeks
The Life Engagement scale, developed by Scheier et al. (2006) to assess individuals' life goals and whose Turkish validity and reliability were determined by Akın et al., is a measurement tool consisting of 6 items and a single dimension (life engagement). The scale has a 5-point scale ("1" I completely disagree, "5" I completely agree). Items 1, 3 and 5 are reverse coded in the scale. Increasing scores indicate a high level of life engagement.
Herth Hope Scale
Time frame: 4 weeks
The Herth Hope Scale was developed by Kaye Herth. The scale consists of 30 items. Each item has four options: "Never " "Rarely appropriate," "Sometimes" and "Always " . The corresponding scores are 0, 1, 2, and 3, respectively. The respondent is asked to mark a single option for each item. The scale consists of 3 sub-dimensions. These are "Future," "Positive Readiness and Expectation," and "Relationships Between Oneself and Those Around Oneself." The "Future" sub-dimension measures the cognitive-temporal dimension of hope, the "Positive Readiness and Expectation" sub-dimension measures the emotional-behavioral dimension of hope, and the "Relationships Between Oneself and Those Around Oneself" sub-dimension measures the dimension of hope related to relationships and the conditions in which it exists. The total hope score varies between 0-90, and the total score of each subscale varies between 0-30. High scores, It shows that hope is high.
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 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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 lauhgter yoga in people with Cancer and Nurse's Role, 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?
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 26 Aug 2026. 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?
Edmonton Symptom Assesment Scale (ESAS) (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 26 Aug 2026.