ElderlyNCT07352774
Effects of Laughter Therapy on Respiratory Functions and Geriatric Pain in Elderly Individuals
A study testing Laughter Therapy in people with Elderly and Respiratory Function, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of laughter therapy on respiratory functions and geriatric pain in elderly individuals. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly, Respiratory Function, Pain
- 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
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Nov 2025to 15 Jan 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Members of the Dikmen Retirees' Club, who do not accept to leave, are 60 years of age or older, have any work, visual, mental or orthopedic disability that would prevent them from participating in the sections, including those who smoke and use alcohol.
Who cannot join
- Being under 60 years of age and having conditions that prevent the application of laughter therapy (having had abdominal surgery in the last three months, glaucoma, hernia and epilepsy), smoking and drinking alcohol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aimed to evaluate the effects of laughter therapy on respiratory functions and geriatric pain in elderly individuals.
Read the detailed description
Structural and functional changes occur with aging and are seen as a decrease in body functions. One of the body systems of aging is the respiratory system capacity. Aging causes the lung tissue to lose elasticity, the respiratory muscles to weaken, and the gas exchange to not be carried out effectively, causing a decrease in respiratory capacity. Therefore, it causes shortness of breath in individuals, an increase in the risk of climate change, and a decrease in the quality of life. Changes in body systems also cause chronic pain in the elderly. Pain-related loss of strength, functional losses, and multiple drug use are observed. Complementary treatment methods can be used against these changes caused by aging, to reduce the problems of old age and for healthy aging. The aim of these therapies is to increase the respiratory capacity of the elderly and the intensity of geriatric pain.
The universe of the study consists of individuals who are members of a Retirement Club affiliated to Ankara Metropolitan Municipality and who do not have any visual, auditory, mental or orthopedic disabilities, aged 60 and over and who agreed to participate in the study. 64 individuals who meet the inclusion criteria constitute the sample of this study. The sample will be randomly selected from the true random number selector (https://www.random.org/) website. Random selections will be planned as a sequential intervention and a control group, respectively. Selection will continue until the sample size is completed. As part of the pre-test, an introductory information form, Respiratory Function Test, oxygen saturation measurement with pulse oximeter, respiration count and Geriatric Pain Scale will be applied to the individuals in the intervention and control groups. The intervention group will receive 8 sessions of laughter therapy twice a week for 4 weeks. No intervention will be applied to the control group. As part of the post-test, the intervention and control groups will be applied; Respiratory Function Test, oxygen saturation measurement with pulse oximetry, respiratory count and Geriatric Pain Scale will be applied. Research data will be analyzed using the Statistical Package for Social Sciences (SPSS) 25.0 program.
Laughter therapy is a complementary medicine technique that combines laughter for no reason and breathing exercises. Laughter therapy is a free, accessible, effective and enjoyable intervention for individuals. Laughter therapy has been accepted as a nursing intervention in the Nursing Intervention Classification at the international level. Laughter therapy increases lung capacity and ensures effective gas exchange thanks to the breathing exercises it contains. It is thought that laughter therapy, which includes breathing exercises, can also provide positive developments in respiratory parameters. Laughter therapy is thought to be an effective intervention in improving respiratory functions and reducing pain.
- Conditions
- Elderly, Respiratory Function, Pain
- Being tested
- Laughter Therapy
- Keywords
- Laughter Therapy, Respiratory Function, Pain, Elderly
- Medical subject headings
- Respiratory Aspiration, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter TherapyBehavioural
A laughter therapy session lasts 45-50 minutes. It includes 10 minutes of warm-up exercises, 15 minutes of breathing exercises, and 15 minutes of laughter exercises. It concludes with a 5-10-minute meditation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | A pulmonary function test and a geriatric pain scale were administered to this group. No intervention was made. A pulmonary function test and a geriatric pain scale were administered again one month later. |
| Laughter Therapy | Experimental | A pulmonary function test and a geriatric pain scale were administered to this group and this group received laughter therapy 8 times in total, twice a week for 1 month. Respiratory function test and geriatric pain scale were applied before the intervention. Receives: Behavioral: Laughter Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Pain Scale
The original scale, called the Geriatric Pain Measure, is a twenty-four-item multidimensional scale developed by Ferrell and colleagues in 2000. The scale adapted for Turkish has five dimensions, as in the original. It includes subscales for pain withdrawal (items 19, 20, 22, and 23), pain intensity (items 1, 2, 3, 4, 5, and 6), pain with movement (items 9, 10, 11, and 12), pain due to strenuous activities (items 7, 8, 18, 21, and 24), and pain due to other activities (items 13, 14, 15, 16, and 17). The scale includes two open-ended questions (items 19 and 20). These questions are scored from 0 to 10. For the other 22 items, each "Yes" response is summed and multiplied by 2.38. The total possible score ranges from 0 to 100. A score between 0 and 29 indicates mild pain, a score between 30 and 69 indicates moderate pain, and a score of 70 or above indicates severe pain. The total Cronbach's alpha value for the scale is 0.85.
Measured: 4 weeks
Forced Vital Capasity: FVC
Mean Change from Baseline in Forced Vital Capacity (FVC) at Week 4. FVC is the total amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It will be used to assess the improvement or stabilization of total lung volume.
Unit of Measure: Liters (L)
Measured: 4 weeks
Forced Expiratory Volume in 1 Second: FEV1
Mean Change from Baseline in Forced Expiratory Volume in 1 Second at week 4. The absolute volume of air exhaled during the first second of the forced vital capacity maneuver. The highest value from three acceptable maneuvers will be recorded in liters (L).
Measured: 4 weeks
FEV1/FVC Ratio
Mean Change from Baseline in FEV1/FVC Ratio at Week 4. This ratio (Tiffeneau-Pinelli index) represents the percentage of vital capacity a person can deliver in the first second of a forced exhalation. It is used to differentiate obstructive and restrictive lung patterns.
Unit of Measurement: Percentile
Measured: 4 weeks
Peak Expiratory Flow: PEF
Mean Change from Baseline in Peak Expiratory Flow (PEF) at Week 4. PEF measures the maximum exhalation rate.
Unit of Measurement: Liters/minute (L/min)
Measured: 4 weeks
Forced Expiratory Flow: FEF 25-75
Change from Baseline in Forced Expiratory Flow Between 25% and 75% of Vital Capacity (FEF 25-75%) at Week 4. This measure reflects the flow rate during the middle half of the FVC maneuver and is a sensitive indicator of small airway function.
Unit of Measure: Liters per second (L/sec)
Measured: 4 weeks
Secondary outcomes (1)
Oxygen Saturation
Mean Change from Baseline in Oxygen Saturation at Week 4 Oxygen saturation indicates the oxygenation level of the blood.
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 posted20 Jan 2026
- Study start6 Nov 2025
- Primary completion16 Nov 2025
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two randomly controlled groups.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisa Nur AKBAL, Ankara University
- Investigators
- Fatma Özlem Öztürk, ASSOCİATE PROFESSOR, Study director, ANKARA UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352774
- Sponsor's protocol ID
- AnkaraU-Nrs-NA-01
- Other IDs
- TYL-2025-4407
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laughter Therapy on Respiratory Functions and Geriatric Pain in Elderly Individuals
- ClinicalTrials.gov ID
- NCT07352774
- Acronym / sponsor ID
- AnkaraU-Nrs-NA-01
- Conditions
- Elderly, Respiratory Function, Pain
- Keywords
- Laughter Therapy, Respiratory Function, Pain, Elderly
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 16 Nov 2025 (actual)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 20 Jan 2026 (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 aimed to evaluate the effects of laughter therapy on respiratory functions and geriatric pain in elderly individuals.
Detailed description
Structural and functional changes occur with aging and are seen as a decrease in body functions. One of the body systems of aging is the respiratory system capacity. Aging causes the lung tissue to lose elasticity, the respiratory muscles to weaken, and the gas exchange to not be carried out effectively, causing a decrease in respiratory capacity. Therefore, it causes shortness of breath in individuals, an increase in the risk of climate change, and a decrease in the quality of life. Changes in body systems also cause chronic pain in the elderly. Pain-related loss of strength, functional losses, and multiple drug use are observed. Complementary treatment methods can be used against these changes caused by aging, to reduce the problems of old age and for healthy aging. The aim of these therapies is to increase the respiratory capacity of the elderly and the intensity of geriatric pain.
The universe of the study consists of individuals who are members of a Retirement Club affiliated to Ankara Metropolitan Municipality and who do not have any visual, auditory, mental or orthopedic disabilities, aged 60 and over and who agreed to participate in the study. 64 individuals who meet the inclusion criteria constitute the sample of this study. The sample will be randomly selected from the true random number selector (https://www.random.org/) website. Random selections will be planned as a sequential intervention and a control group, respectively. Selection will continue until the sample size is completed. As part of the pre-test, an introductory information form, Respiratory Function Test, oxygen saturation measurement with pulse oximeter, respiration count and Geriatric Pain Scale will be applied to the individuals in the intervention and control groups. The intervention group will receive 8 sessions of laughter therapy twice a week for 4 weeks. No intervention will be applied to the control group. As part of the post-test, the intervention and control groups will be applied; Respiratory Function Test, oxygen saturation measurement with pulse oximetry, respiratory count and Geriatric Pain Scale will be applied. Research data will be analyzed using the Statistical Package for Social Sciences (SPSS) 25.0 program.
Laughter therapy is a complementary medicine technique that combines laughter for no reason and breathing exercises. Laughter therapy is a free, accessible, effective and enjoyable intervention for individuals. Laughter therapy has been accepted as a nursing intervention in the Nursing Intervention Classification at the international level. Laughter therapy increases lung capacity and ensures effective gas exchange thanks to the breathing exercises it contains. It is thought that laughter therapy, which includes breathing exercises, can also provide positive developments in respiratory parameters. Laughter therapy is thought to be an effective intervention in improving respiratory functions and reducing pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two randomly controlled groups.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –A pulmonary function test and a geriatric pain scale were administered to this group. No intervention was made. A pulmonary function test and a geriatric pain scale were administered again one month later. |
| Laughter Therapy | Experimental | Behavioral: Laughter TherapyA pulmonary function test and a geriatric pain scale were administered to this group and this group received laughter therapy 8 times in total, twice a week for 1 month. Respiratory function test and geriatric pain scale were applied before the intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Members of the Dikmen Retirees' Club, who do not accept to leave, are 60 years of age or older, have any work, visual, mental or orthopedic disability that would prevent them from participating in the sections, including those who smoke and use alcohol.
Key exclusion criteria (1 listed)
- Being under 60 years of age and having conditions that prevent the application of laughter therapy (having had abdominal surgery in the last three months, glaucoma, hernia and epilepsy), smoking and drinking alcohol.
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 TherapyA laughter therapy session lasts 45-50 minutes. It includes 10 minutes of warm-up exercises, 15 minutes of breathing exercises, and 15 minutes of laughter exercises. It concludes with a 5-10-minute meditation. | Behavioural | Laughter Therapy |
Primary outcome
Geriatric Pain Scale
Time frame: 4 weeks
The original scale, called the Geriatric Pain Measure, is a twenty-four-item multidimensional scale developed by Ferrell and colleagues in 2000. The scale adapted for Turkish has five dimensions, as in the original. It includes subscales for pain withdrawal (items 19, 20, 22, and 23), pain intensity (items 1, 2, 3, 4, 5, and 6), pain with movement (items 9, 10, 11, and 12), pain due to strenuous activities (items 7, 8, 18, 21, and 24), and pain due to other activities (items 13, 14, 15, 16, and 17). The scale includes two open-ended questions (items 19 and 20). These questions are scored from 0 to 10. For the other 22 items, each "Yes" response is summed and multiplied by 2.38. The total possible score ranges from 0 to 100. A score between 0 and 29 indicates mild pain, a score between 30 and 69 indicates moderate pain, and a score of 70 or above indicates severe pain. The total Cronbach's alpha value for the scale is 0.85.
Forced Vital Capasity: FVC
Time frame: 4 weeks
Mean Change from Baseline in Forced Vital Capacity (FVC) at Week 4. FVC is the total amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It will be used to assess the improvement or stabilization of total lung volume. Unit of Measure: Liters (L)
Forced Expiratory Volume in 1 Second: FEV1
Time frame: 4 weeks
Mean Change from Baseline in Forced Expiratory Volume in 1 Second at week 4. The absolute volume of air exhaled during the first second of the forced vital capacity maneuver. The highest value from three acceptable maneuvers will be recorded in liters (L).
FEV1/FVC Ratio
Time frame: 4 weeks
Mean Change from Baseline in FEV1/FVC Ratio at Week 4. This ratio (Tiffeneau-Pinelli index) represents the percentage of vital capacity a person can deliver in the first second of a forced exhalation. It is used to differentiate obstructive and restrictive lung patterns. Unit of Measurement: Percentile
Peak Expiratory Flow: PEF
Time frame: 4 weeks
Mean Change from Baseline in Peak Expiratory Flow (PEF) at Week 4. PEF measures the maximum exhalation rate. Unit of Measurement: Liters/minute (L/min)
Forced Expiratory Flow: FEF 25-75
Time frame: 4 weeks
Change from Baseline in Forced Expiratory Flow Between 25% and 75% of Vital Capacity (FEF 25-75%) at Week 4. This measure reflects the flow rate during the middle half of the FVC maneuver and is a sensitive indicator of small airway function. Unit of Measure: Liters per second (L/sec)
1 secondary outcome
Oxygen Saturation
Time frame: 4 weeks
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 20 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available upon request.
Related trials for Elderly
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
Fatma Özlem Öztürk, ASSOCİATE PROFESSOR study director
ANKARA UNİVERSİTY
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 Elderly and Respiratory Function, run by Ankara 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 1 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: enrolling by invitation, as of the sponsor's last update on 20 Jan 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?
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?
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?
Geriatric Pain Scale (time frame: 4 weeks). The study lists 6 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 20 Jan 2026.