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NCT Number: NCT07352774

Effects of Laughter Therapy on Respiratory Functions and Geriatric Pain in Elderly Individuals

This study aimed to evaluate the effects of laughter therapy on respiratory functions and geriatric pain in elderly individuals.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

Ankara, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Laughter Therapy

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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)

  3. 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).

  4. 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

  5. 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)

  6. 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)

Secondary outcomes

  1. Oxygen Saturation

    Time frame: 4 weeks

    Mean Change from Baseline in Oxygen Saturation at Week 4 Oxygen saturation indicates the oxygenation level of the blood.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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