LaughterNCT06722872
The Effect of Laughter Therapy on the Mental Health of Elderly Living in a Nursing Home
A study testing Laughter therapy in people with Laughter and Mental Health Issue, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study was designed and conducted as a randomized controlled experimental research with a pre-test and post-test control group to evaluate the effect of laughter therapy on psychological well-being, life satisfaction, and mental health of elderly individuals living in a nursing home. Read more about this study
- Who is it for?
- Ages 65 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Laughter, Mental Health Issue, Life Satisfaction
- What is being tested?
- Laughter therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2024to 26 Jun 2024
- 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 65 to 105 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being over the age of 65
- Scoring ≥ 18 points on the Mini-Mental Examination
- Having the ability to communicate
- Not having participated in a laughter therapy session before
Who cannot join
- Having severe hearing or perception impairment that hinders communication
- Having a physical or psychological condition that prevents participation in therapy
- Having moderate-to-severe Alzheimer's disease, uncontrolled hypertension, epilepsy, abdominal surgery within the past 3 months, or a surgical procedure with a risk of bleeding
- Choosing not to continue participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laughter Therapy on Psychological Well-being, Life Satisfaction and Mental Health of the Elderly Living in a Nursing Home
This study was designed and conducted as a randomized controlled experimental research with a pre-test and post-test control group to evaluate the effect of laughter therapy on psychological well-being, life satisfaction, and mental health of elderly individuals living in a nursing home.
Read the detailed description
Among the most important indicators of successful aging are individuals' ability to derive satisfaction from life, maintain cognitive and social competence, sustain mental and physical health, possess a sense of personal control, and experience increased longevity. Supporting elderly individuals to live independently, maintaining their social relationships, and encouraging healthy lifestyle behaviors are key to achieving an active and successful aging process.
Life satisfaction is considered one of the most significant factors influencing mental health and determining adaptation during all stages of life, particularly in old age. As an indicator of well-being, life satisfaction has a positive correlation with psychological resilience and mental health. Thus, psychological well-being, life satisfaction, and mental health of elderly individuals are interconnected, and interventions aimed at enhancing well-being and life satisfaction are known to positively affect the mental health of older adults.
In this context, laughter therapy has recently gained attention as an approach with observed positive effects on the physical and mental health of elderly individuals. Laughter therapy, developed by Dr. Madan Kataria in 1995, aims to support physical and mental health through laughter and breathing exercises.
Meta-analyses and systematic reviews indicate that laughter therapy has positive psychosocial effects on older adults, including reducing depression, perceived stress, and anxiety, enhancing psychological well-being, regulating blood pressure and cortisol levels, improving sleep and quality of life, reducing death anxiety, loneliness, and depressive tendencies, and increasing happiness, life satisfaction, and mood. Laughter therapy is considered a non-invasive, non-pharmacological, cost-effective, accessible, and easy-to-apply complementary/alternative therapy, with calls for further evidence-based studies to promote its use.
Within this framework, the aim of this research is to determine the effect of laughter therapy on the psychological well-being, life satisfaction, and mental health of elderly individuals.
- Being tested
- Laughter therapy
- Keywords
- Laughter therapy, Old age, Psychological well-being, Life satisfaction, Mental health
- Medical subject headings
- Laughter, Personal Satisfaction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter therapyOther
Laughter therapy, developed by Dr. Madan Kataria in 1995, is a structured exercise program use of laughter and breathing exercises.Laughter therapy sessions begin with warm-up techniques, including clapping, singing, and stretching movements. These are followed by breathing exercises to prepare the lungs for laughter. After the breathing exercises, laughter is simulated using acting techniques. Shortly thereafter, the simulated laughter spreads from person to person through group dynamics, transforming into genuine laughter, which is then followed by a series of laughter exercises. A laughter therapy session may conclude with laughter meditation, during which participants allow natural laughter to flow freely, followed by guided relaxation exercises. To maximize the benefits of laughter's contagious nature, it is recommended that laughter therapy be conducted in groups. Each session varies depending on the target audience, typically lasting around 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Laughter therapy group | Experimental | Pre-tests were collected 10 days before the therapy began. The elderly participants were introduced individually and informed face-to-face about laughter therapy. Therapy sessions were conducted face-to-face twice a week, with a total of 12 sessions. Each laughter therapy session lasted 50 minutes. Post-tests were collected immediately after the final therapy session. Four weeks later, follow-up tests were also conducted face-to-face. Receives: Other: Laughter therapy |
| No intervention group | No intervention | The control group did not receive laughter therapy; they continued with routine nursing home care. Pre-tests, post-tests, and follow-up tests were collected on the same days as the experimental group. After the follow-up tests were completed, a 30-minute laughter therapy session was provided to control group participants who wished to participate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Well-Being Scale for Older Adults
The scale was used to measure the psychological well-being levels of older adults. It consists of 15 items in a 5-point Likert format (1 = Strongly Disagree to 5 = Strongly Agree). No specific cutoff score has been determined for the well-being levels of older adults. Higher scores indicate an increase in the level of well-being. The minimum score obtainable from the scale is 15, while the maximum score is 75.
Measured: Pre-test, Post-test (6th week), Follow-up Test (4th week)
Life Satisfaction Scale for Older Adults
The scale was used to assess the participation of older adults in the process of life satisfaction. It consists of 14 items across 3 subdimensions and is structured as a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). The scale includes 9 items under the "Self-Acceptance" subdimension, 2 items under the "Motivation" subdimension, and 3 items under the "Peace" subdimension. Scores range from 14 to 70, with individual subdimension scores calculated by dividing the total score by the number of items in each subdimension. The "Self-Acceptance" subdimension ranges from 9 to 45, the "Motivation" subdimension from 2 to 10, and the "Peace" subdimension from 3 to 15.
Measured: Pre-test, Post-test (6th week), Follow-up Test (4th week)
Depression Anxiety Stress Scale (DASS-21)
The scale was used to assess the mood of older adults by identifying their levels of depression, anxiety, and stress. DASS-21 is a shortened version of the 42-item Depression Anxiety Stress Scale. It consists of 21 items in a 4-point Likert format (0 = Never, 1 = Sometimes, 2 = Often, 3 = Always) and includes three subdimensions: depression, anxiety, and stress. Each subdimension is measured by 7 questions.
Measured: Pre-test, Post-test (6th week), Follow-up Test (4th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start16 Apr 2024
- Primary completion26 May 2024
- Study completion26 Jun 2024
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.
- More trials run by Istanbul University - CerrahpasaThe 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
- Model description
- Two groups with experimental and control groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Karaca, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722872
- Sponsor's protocol ID
- IstanbulUC-NURS-OK-01
- Status last verified
- Jun 2026
- First submitted
- 3 Dec 2024
- Last updated
- 1 Jul 2026
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laughter Therapy on Psychological Well-being, Life Satisfaction and Mental Health of the Elderly Living in a Nursing Home
- ClinicalTrials.gov ID
- NCT06722872
- Acronym / sponsor ID
- IstanbulUC-NURS-OK-01
- Keywords
- Laughter therapy, Old age, Psychological well-being, Life satisfaction, Mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 26 May 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 9 Dec 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.
This study was designed and conducted as a randomized controlled experimental research with a pre-test and post-test control group to evaluate the effect of laughter therapy on psychological well-being, life satisfaction, and mental health of elderly individuals living in a nursing home.
Detailed description
Among the most important indicators of successful aging are individuals' ability to derive satisfaction from life, maintain cognitive and social competence, sustain mental and physical health, possess a sense of personal control, and experience increased longevity. Supporting elderly individuals to live independently, maintaining their social relationships, and encouraging healthy lifestyle behaviors are key to achieving an active and successful aging process.
Life satisfaction is considered one of the most significant factors influencing mental health and determining adaptation during all stages of life, particularly in old age. As an indicator of well-being, life satisfaction has a positive correlation with psychological resilience and mental health. Thus, psychological well-being, life satisfaction, and mental health of elderly individuals are interconnected, and interventions aimed at enhancing well-being and life satisfaction are known to positively affect the mental health of older adults.
In this context, laughter therapy has recently gained attention as an approach with observed positive effects on the physical and mental health of elderly individuals. Laughter therapy, developed by Dr. Madan Kataria in 1995, aims to support physical and mental health through laughter and breathing exercises.
Meta-analyses and systematic reviews indicate that laughter therapy has positive psychosocial effects on older adults, including reducing depression, perceived stress, and anxiety, enhancing psychological well-being, regulating blood pressure and cortisol levels, improving sleep and quality of life, reducing death anxiety, loneliness, and depressive tendencies, and increasing happiness, life satisfaction, and mood. Laughter therapy is considered a non-invasive, non-pharmacological, cost-effective, accessible, and easy-to-apply complementary/alternative therapy, with calls for further evidence-based studies to promote its use.
Within this framework, the aim of this research is to determine the effect of laughter therapy on the psychological well-being, life satisfaction, and mental health of elderly individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| Laughter therapy group | Experimental | Other: Laughter therapyPre-tests were collected 10 days before the therapy began. The elderly participants were introduced individually and informed face-to-face about laughter therapy. Therapy sessions were conducted face-to-face twice a week, with a total of 12 sessions. Each laughter therapy session lasted 50 minutes. Post-tests were collected immediately after the final therapy session. Four weeks later, follow-up tests were also conducted face-to-face. |
| No intervention group | No intervention | –The control group did not receive laughter therapy; they continued with routine nursing home care. Pre-tests, post-tests, and follow-up tests were collected on the same days as the experimental group. After the follow-up tests were completed, a 30-minute laughter therapy session was provided to control group participants who wished to participate. |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Being over the age of 65
- Scoring ≥ 18 points on the Mini-Mental Examination
- Having the ability to communicate
- Not having participated in a laughter therapy session before
Key exclusion criteria (4 listed)
- Having severe hearing or perception impairment that hinders communication
- Having a physical or psychological condition that prevents participation in therapy
- Having moderate-to-severe Alzheimer's disease, uncontrolled hypertension, epilepsy, abdominal surgery within the past 3 months, or a surgical procedure with a risk of bleeding
- Choosing not to continue participating in the study
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 therapyLaughter therapy, developed by Dr. Madan Kataria in 1995, is a structured exercise program use of laughter and breathing exercises.Laughter therapy sessions begin with warm-up techniques, including clapping, singing, and stretching movements. These are followed by breathing exercises to prepare the lungs for laughter. After the breathing exercises, laughter is simulated using acting techniques. Shortly thereafter, the simulated laughter spreads from person to person through group dynamics, transforming into genuine laughter, which is then followed by a series of laughter exercises. A laughter therapy session may conclude with laughter meditation, during which participants allow natural laughter to flow freely, followed by guided relaxation exercises. To maximize the benefits of laughter's contagious nature, it is recommended that laughter therapy be conducted in groups. Each session varies depending on the target audience, typically lasting around 45 minutes. | Other | Laughter therapy group |
Primary outcome
Psychological Well-Being Scale for Older Adults
Time frame: Pre-test, Post-test (6th week), Follow-up Test (4th week)
The scale was used to measure the psychological well-being levels of older adults. It consists of 15 items in a 5-point Likert format (1 = Strongly Disagree to 5 = Strongly Agree). No specific cutoff score has been determined for the well-being levels of older adults. Higher scores indicate an increase in the level of well-being. The minimum score obtainable from the scale is 15, while the maximum score is 75.
Life Satisfaction Scale for Older Adults
Time frame: Pre-test, Post-test (6th week), Follow-up Test (4th week)
The scale was used to assess the participation of older adults in the process of life satisfaction. It consists of 14 items across 3 subdimensions and is structured as a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). The scale includes 9 items under the "Self-Acceptance" subdimension, 2 items under the "Motivation" subdimension, and 3 items under the "Peace" subdimension. Scores range from 14 to 70, with individual subdimension scores calculated by dividing the total score by the number of items in each subdimension. The "Self-Acceptance" subdimension ranges from 9 to 45, the "Motivation" subdimension from 2 to 10, and the "Peace" subdimension from 3 to 15.
Depression Anxiety Stress Scale (DASS-21)
Time frame: Pre-test, Post-test (6th week), Follow-up Test (4th week)
The scale was used to assess the mood of older adults by identifying their levels of depression, anxiety, and stress. DASS-21 is a shortened version of the 42-item Depression Anxiety Stress Scale. It consists of 21 items in a 4-point Likert format (0 = Never, 1 = Sometimes, 2 = Often, 3 = Always) and includes three subdimensions: depression, anxiety, and stress. Each subdimension is measured by 7 questions.
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 1 Jul 2026.
- 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.
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 Laughter therapy in people with Laughter and Mental Health Issue, run by Istanbul University - Cerrahpasa 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 4 inclusion and 4 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 1 Jul 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?
Psychological Well-Being Scale for Older Adults (time frame: Pre-test, Post-test (6th week), Follow-up Test (4th week)). 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 1 Jul 2026.