CompletedNot Applicable

The Effect of Pursed Lip Breathing Exercise and Laughter Therapy Individuals With The COPD

Turkey (Türkiye)63 participantsStarted 2022-08-15

Plain-language summary

Chronic Obstructive Pulmonary Disease is a chronic disease with increasing mortality, morbidity and prevalence in the world and in our country, and in which serious symptoms, especially dyspnea, develop. Due to dyspnea and symptoms, patients experience deterioration in their health status and an increase in care dependency. This research is a single-blind, randomized controlled experimental study designed to determine the effects of pursed lip breathing exercise and laughter therapy on dyspnea severity, health status and care dependence in individuals with COPD. The research will be carried out with a total of 63 patients in Ankara City Hospital Chest Diseases unit. The patients will be stratified according to smoking status and COPD Assessment Test scores with the randomization program and assigned to 2 intervention groups and 1 control group. During the first interview, patients in the 1st intervention group will be provided with pursed lip breathing exercise training and application, and training videos and brochures will be given. 2. The patients in the intervention group will be given laughter therapy training and practice, and an educational brochure will be given. The patients in the control group will also receive face-to-face training on lung structure and functioning, and a brochure will be given. Patients in the laughter therapy and pursed lip breathing exercise intervention groups will be asked to perform these practices three days a week (Monday, Wednesday, Friday) for 8 weeks. At the beginning of the study, at the 4th, 8th, and 12th weeks, the Dyspnea 12-TR Scale, the COPD Evaluation Test, and the Care Dependency Scale will be administered to both the intervention and control group patients. In the application of the scales and the analysis of the data, the groups will be blinded, and the scale application will be made by an independent interviewer. After the analysis of the data in terms of normal distribution was done with the Kolmogorow Smirnov test, in the comparison of the data of the patients in the intervention and control groups; One Way Analysis of Variance or Kruskal-Wallis Analysis of Variance will be applied. Analysis of Variance in Repeated Measurements or Freidman's test will be used to calculate the change in groups over time. The statistical significance limit will be accepted as p\<0.05.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Those aged 40 and over, * He was diagnosed with COPD as a result of medical history, physical examination and pulmonary function tests, and his CAT score is 10 and above according to the COPD Unified Assessment\* of the GOLD guide; In Group B and D (1), * There is no diagnosis of a disease that may affect the cognitive state, * Not having a diagnosis of a physical or mental illness that will prevent communication, and able to use a telephone. * Individuals who agree to participate in the research are included in the study Non-Inclusion Criteria: Those who have difficulty in verbal communication (intubation, tracheostomy, delirium, etc.) * With a CAT score of less than 10 and in Groups A and C according to the COPD Combined Assessment\* of the GOLD guide, * Having a disorder that disrupts the cognitive process such as schizophrenia or dementia * Alcohol, substance addiction, * Laughter therapy was not deemed appropriate due to the diagnosis of abdominal surgery, uncontrolled hypertension, glaucoma, abdominal hernia, epilepsy in the last three months, * Using complementary and integrative treatments such as acupuncture, meditation, yoga, massage, relaxation exercises, * Patients who do not agree to participate in the study are excluded from the study. Exclusion criteria * Not complying with pursed lip breathing exercise and laughter therapy and program, * Developing a disease that may affect the health status or a condition requiring hospitalization …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dyspnea in the COPD

Timeframe: 12 week

Trial details

NCT IDNCT05997550

SponsorYuksek Ihtisas University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-15

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials