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

NCT07352774 | Enrolling By Invitation DMC

• 2 other identifiers: AnkaraU-Nrs-NA-01TYL-2025-4407
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Elderly; Respiratory Function; Pain

Keywords

Laughter Therapy; Respiratory Function; Pain; Elderly

Outcome Measures

Primary Outcomes (6)

• 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.

  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)

  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).

  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

  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)

  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)

  4 weeks

Secondary Outcomes (1)

• Oxygen Saturation

  4 weeks

Study Arms (2)

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.

Behavioral: Laughter Therapy

Interventions

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.

Laughter Therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration; Pain

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Fatma Özlem Öztürk, ASSOCİATE PROFESSOR

  ANKARA UNİVERSİTY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two randomly controlled groups.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 20, 2026
• Study Start: November 6, 2025
• Primary Completion: November 16, 2025
• Study Completion: January 15, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available beginning 6 months after publication of the study results and for a period of 5 years.
• Access Criteria: Researchers must provide a formal request and a statistically sound proposal to access the data. Requests will be reviewed by the principal investigator.

Locations

TU (1)