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

NCT05997550 | Completed

• 1 other identifier: COPD.NURSİNG.YUKSEK
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Dyspnea; Health Status; Pursed Lip Breathing Exercise; Laughter Therapy; care Dependence

Outcome Measures

Primary Outcomes (1)

• Dyspnea in the COPD

  Dyspnea-12 Scale, all patients in the intervention and control groups; On the first interview day, they are told to take a break from the 4th, 8th and pursed lip breathing exercise and laughter therapy programs for 4 weeks, and they are applied again in the 12th week. Dyspnea -12 scale, Yorke et al (2010) to measure the severity of dyspnea and to evaluate it with emotional and physical dimensions. The first 7 items measure whether the inhaled air fills all the lungs, the difficulty in breathing and the physical limitations of dyspnea in which the required effort is questioned. The other 5 items of the scale question emotional states such as stress, irritability and depression that may arise from shortness of breath. The severity of dyspnea is directly proportional to the scores obtained from the scale, and as the scores increase, the severity of dyspnea increases

  12 week

Secondary Outcomes (1)

• Health Status in The COPD

  12 week

Other Outcomes (1)

• Care Dependence in The COPD

  12 week

Study Arms (3)

Pursed Lip Breathing Exercise Group

ACTIVE COMPARATOR

During the first interview, the training and demonstration of pursed lip breathing exercise is performed by the thesis student in a single session. After this information session, the pursed lip breathing exercise taught from the patients; They are asked to do it in their own homes, 3 days a week on Monday, Wednesday and Friday, for about 30 minutes each session, for a total of eight weeks. In addition, one day a week (on a day determined by the patient, Monday, Wednesday or Friday), the thesis student makes a video call to the patient on WhatsApp, and the practice of pursed lip breathing exercise is performed during the video call.

Other: Pursed Lip Breathing Exercise

Laughter Therapy Group

ACTIVE COMPARATOR

During the first interview, laughter therapy training and demonstration is carried out by the thesis student in a single session. After this information session, the laughter therapy taught from the patients; They are asked to do this in their own homes, 3 days a week on Monday, Wednesday and Friday, 30 minutes each session, for a total of eight weeks. . In addition, once a week (on a day determined by the patient, Monday, Wednesday or Friday), the thesis student makes a video call to the patient on WhatsApp, and laughter therapy is practiced during the video call.

Other: Laughter Therapy

Control Group

PLACEBO COMPARATOR

Attention-match training is given to the patients in the control group. During the first interview, attention matching training is carried out by the thesis student for one time, about "Lung structure and functioning", lasting approximately 20 minutes. In addition, a brochure about lung structure and functioning is given to patients. The patients in the control group are not subjected to any other interventions throughout the study.

Other: the control group.

Interventions

Pursed Lip Breathing Exercise OTHER

Pursed Lip Breathing Exercise for The COPD

Pursed Lip Breathing Exercise Group

Laughter Therapy OTHER

Laughter Therapy for the COPD

Laughter Therapy Group

the control group. OTHER

Attention-match training is given to the patients in the control group.

Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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 (COPD exacerbation, etc.) during the 12-week period during which the research will take place,
• Changes in bronchodilator and oxygen therapy regimens,
• A situation that is not suitable for laughter therapy due to the diagnosis of surgery in the abdominal region, uncontrollable hypertension, glaucoma, abdominal hernia, epilepsy,
• Patients who want to withdraw from the study are excluded from the study.

Sponsors & Collaborators

• Yuksek Ihtisas University: lead

Study Sites (1)

Bilkent City Hospital

Ankara, Çamlıca Mahallesi, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Goncagul ALDAN

  yüksek İhtisas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: August 18, 2023
• Study Start: August 15, 2022
• Primary Completion: August 15, 2024
• Study Completion: October 15, 2024
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The data will be available beginning 3 months after publication and will remain available for 2 years following publication.
• Access Criteria: Access to de-identified individual participant data will be limited to researchers with an approved research proposal. Data access will be granted on a case-by-case basis and in accordance with ethical and institutional regulations.

Locations

TU (1)