Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
The Effect of Pursed Lip Breathing Exercise and Laughter Therapy on Dyspnea, Health Status, and Care Dependence in Individuals With Chronic Obstructive Pulmonary Disease
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.
Status | Not yet recruiting |
Enrollment | 63 |
Est. completion date | March 15, 2025 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 (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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Yuksek Ihtisas University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Care Dependence in The COPD | COPD assessment test, 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.
Care Dependence Scale (CDS) Dijkstra et al. (1999) to evaluate the individual's dependence on care and to deal with addiction with its physical and psychological dimensions .The scale includes nutrition, continence, body posture, mobility, sleep, dressing, body temperature, body cleanliness, avoiding danger, verbal communication, communicating with others, worshiping, obeying rules, daily activities, recreational activities, memory and learning ability. A high scale score indicates that the patient is independent in meeting his/her care needs, while a low scale score indicates that the patient is dependent on others to meet their care needs. |
12 week | |
Primary | 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 | Health Status in The COPD | COPD assessment test, 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.
COPD assessment test, Jones et al. (2009) to measure health status in COPD and to evaluate the disease effect and severity. The eight-question test provides information on the grading of the disease, the scoring of symptoms, and the impact on the patient's quality of life. It covers problems such as shortness of breath, cough, and sputum production, as well as symptoms such as fatigue and sleep problems. Perfect health status: 0 points (minimum score), worst health status: 40 points (maximum score). |
12 week |
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