- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07820059
The Effect of Pranayama Practiced With Rain Sounds on Self-Efficacy, Dyspnea, and Respiratory Functions in Patients With COPD
Study Overview
Status
Conditions
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous disease that develops as a result of irreversible airway obstruction and is characterized by lung tissue destruction. COPD is a progressive inflammatory disease of the lungs and is among the most common respiratory diseases (1). The World Health Organization predicts that COPD will rank third among the leading causes of death within the next 10 years (2). The high morbidity and mortality rates associated with COPD also lead to an increased economic burden. Although the prevalence of COPD varies among countries, the risk factors are found to be similar (3). When examining these risk factors, it is evident that there are numerous environmental and genetic factors, such as tobacco use, inhalation of harmful gases, environmental pollution, exposure to mining dust, cooking over open fires, alpha-1-antitrypsin (AAT) deficiency, and mutations in the TNF-α cytokine (4). Inhalation of these harmful gases leads to a pathological inflammatory response, mucus hypersecretion, and alveolar destruction. This, in turn, results in abnormal remodeling of the airways, increased airway resistance, and a decrease in the elasticity of the lung parenchyma (5). The symptoms and signs of the disease worsen as the disease progresses. While mild symptoms such as intermittent coughing, shortness of breath, and reluctance to engage in physically demanding activities are observed in the early stages of the disease, as the disease progresses, many symptoms-such as chronic cough, chest pain, fatigue, weight loss, and increased mucus secretion-become apparent, in contrast to the early stage (6). Individuals with COPD typically present to the hospital with dyspnea, chronic cough, increased sputum production, and wheezing, and many have experienced an exacerbation before seeking hospital care. The diagnosis is made through clinical evaluation and spirometry (7). For a diagnosis of COPD, the post-bronchodilator FEV1/FVC ratio must be less than 0.7. COPD is classified into four stages based on the percentage of FEV1: Stage 1 (FEV1 ≥ 80%), Stage 2 (50% ≤ FEV1 < 79) Stage 3 (30% ≤ FEV1 < 49%) and Stage 4 (FEV1 < 30%) (2). The goal of COPD treatment is to alleviate symptoms and reduce disease severity and the number of exacerbations. To this end, both pharmacological and nonpharmacological methods are used. Pharmacological methods include bronchodilators, antimuscarinic drugs, corticosteroids, phosphodiesterase-4 inhibitors, and mucolytic agents. Treatment is tailored to the patient's symptoms and the number of attacks (8). Nonpharmacological methods include quitting smoking, physical activity, oxygen therapy, nutrition, pulmonary rehabilitation, breathing exercises, and progressive muscle relaxation exercises (9). In addition to pulmonary rehabilitation, yoga-which incorporates breathing exercises-is also among the nonpharmacological methods. Yoga is a spiritual practice consisting of three components: pranayama, asana, and meditation (10). While asana refers to changing one's physical posture, pranayama refers to the expansion of life force through breath control and involves the processes of inhalation and exhalation. There are many different types of asanas, including Sirshana (headstand), Sarvangasana (shoulder stand), Paschimothanasana (seated forward bend), and Padahastasana (standing forward bend), and the purpose of all of them is to increase lung capacity by serving as a preparatory exercise before pranayama (11). Pranayama consists of three steps: Puraka, Rechaka, and Kumbhaka (inhalation, exhalation, and holding the breath after inhalation). While Puraka explains the subtleties of slow inhalation, Rechaka explains the subtleties of slow exhalation. There are many different types of pranayama techniques, including Nadishodhanam, Kapalbhati, Bhastrika, Ujjayi, Bhramari, Sheetali, Sheetkari, Suryabhedana, Murccha, and Plavini.
The purpose of all types of pranayama breathing is to maintain physical and mental health. In addition, each of these pranayama techniques produces different physiological effects depending on its duration and type (12).
• Nadishodhanam (alternate nostril breathing); this is the simplest type of pranayama to practice. It affects the autonomic nervous system, specifically the sympathetic and parasympathetic systems. It involves the following steps (13): Sit in a comfortable position. Use your thumb to close your right nostril and breathe in through your left nostril.
Slowly release your thumb and close your left nostril with your ring finger. Then, exhale slowly through your right nostril, followed by inhaling through your right nostril and exhaling slowly through your left nostril.
• Bhramari pranayama involves inhaling rapidly while making a sound like a male bee and exhaling slowly while making a sound like a female bee (14).
A review of the literature reveals that, according to Jayawardena's systematic review, pranayama has numerous positive effects, including improving symptoms and activity levels in individuals with chronic obstructive pulmonary disease (COPD), lowering heart rate and systolic blood pressure in those with bronchial asthma, and enhancing quality of life in cancer patients (15).
Listening to the sounds of rain and nature is another relaxation technique. These sounds are produced by natural sources such as rain, wind, the ocean, birds, and animals, and promote physical and mental relaxation. In a study conducted by Kutenai et al. on burn patients, one group was treated with the Benson relaxation technique, while the other group was exposed to nature sounds. The study concluded that patients in the nature sounds group had lower pain levels and a significant reduction in body image dissatisfaction (16).
The study will be conducted using a randomized controlled pre-test-post-test experimental design. The study will be carried out between April 2026 and September 2027 at the Pulmonology Outpatient Clinic of the Turgut Özal Medical Center at İnönü University.
Both Experiment Group 1 (pranayama group with rain sounds) and Experiment Group 2 (pranayama group without rain sounds) will receive information about what pranayama exercises are, their importance, purpose, and benefits. In addition to standard treatment, they will practice pranayama breathing exercises twice daily for 15-20 minutes for 6 weeks. Experiment Group 1 will practice pranayama breathing exercises with rain sounds, while Experiment Group 2 will practice pranayama breathing exercises without rain sounds. Nadhi sodhana/Nadhi Shudi, also known as alternate nostril breathing, is used to help calm the nervous system, soothe the mind, reduce stress, and improve concentration. Because it can be applied to different patient groups and has no complications, Nadhi sodhana Pranayama will be used. To ensure patients can perform Nadhi sodhana Pranayama correctly and completely, a video demonstrating the technique will be prepared and uploaded to their phones. Additionally, patients will receive a pranayama training and practice guide. In a room suitable for the patients, the pranayama practice and its steps will be repeated through both explanation and demonstration until the patient learns, and any points the patient cannot perform will be corrected. Once it is observed that the patients perform the practice completely, they will be asked to perform pranayama breathing exercises twice a day for 15-20 minutes for 6 weeks, and the same researcher will remind them to practice the breathing technique and keep records in patient monitoring charts once a day via text message. In addition, patients will be contacted weekly by the researcher to answer any questions they may have regarding pranayama breathing technique and to discuss their adherence to pranayama breathing exercises, thus ensuring the effectiveness and continuity of the practice and monitoring the patients. If the patients assigned to the experimental groups are unable to perform the practice or experience difficulties, the study with these patients will be terminated. • B) Patients in the control group will not be given any practice in addition to their medical treatment. Individuals will continue their daily lives.
• In the final testing phase of the study (at the end of the sixth week), the COPD Self-Efficacy Scale, Dyspnea 12 Scale, and Visual Analog Scale will be administered again to experimental groups 1 and 2 one day after the pranayama breathing exercises, and to the control group 6 weeks after the pre-test, by the same researcher. A Pulmonary Function Test will also be performed again. Following the administration of these scales and the pulmonary function test, all patients in the control group will receive pranayama breathing exercise training and two sessions at the end of the study. The application will be carried out by Elvan KIRILMAZ.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Serap Parlar Kılıç, Prof. Dr.
- Phone Number: 0557 712 03 94
- Email: serap.parlar@inonu.edu.tr
Study Contact Backup
- Name: Elvan Kırılmaz, Lecturer
- Phone Number: 0551 260 56 88
- Email: elvankirilmaz1@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 18 years of age and older
- Diagnosed with COPD at least 6 months prior based on pulmonary function test results
- Stage 1 (FEV1 > 80%), Stage 2 (50% ≤ FEV1 < 80%), and Stage 3 (30% ≤ FEV1 < 50%) patients meeting GOLD 2021 criteria
- No nasal breathing obstruction
- Possessing sufficient cognitive ability to understand questions,
- No visual or hearing problems,
- No communication problems,
- Using a smartphone
- At least literate
- Volunteering to participate in the study
Exclusion Criteria:
• Those who do not wish to continue the practice
- Those who experience difficulties during the practice
- Those who begin using any alternative treatment in addition to standard care other than pranayama breathing exercises
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pranayama breathing exercise
group practicing pranayama breathing exercises
|
Nadhi sodhana/Nadhi Shudi, also known as alternate nostril breathing, is used to help calm the nervous system, soothe the mind, reduce stress, and improve concentration.
Because it can be applied to different patient groups with various diagnoses and has no complications, Nadhi sodhana Pranayama practice will be conducted.
To ensure patients can perform Nadhi sodhana Pranayama correctly and completely, a video demonstrating the practice will be prepared and uploaded to their phones.
Additionally, patients will receive a pranayama training and practice guide.
In a suitable room, the pranayama practice and its steps will be repeated through explanation and demonstration until the patient learns, and any difficulties will be corrected.
Once patients are observed to be performing the practice correctly, they will be asked to practice pranayama breathing exercises twice a day for 15-20 minutes for 6 weeks.
The researcher will also send a daily text message reminding them to practice the bre
|
|
Experimental: Pranayama breathing exercises accompanied by the sound of rain.
A group practicing pranayama breathing exercises accompanied by the sound of rain.
|
Nadhi sodhana/Nadhi Shudi, also known as alternate nostril breathing, is used to help calm the nervous system, soothe the mind, reduce stress, and improve concentration.
Because it can be applied to different patient groups with various diagnoses and has no complications, Nadhi sodhana Pranayama practice will be conducted.
To ensure patients can perform Nadhi sodhana Pranayama correctly and completely, a video demonstrating the practice will be prepared and uploaded to their phones.
Additionally, patients will receive a pranayama training and practice guide.
In a suitable room, the pranayama practice and its steps will be repeated through explanation and demonstration until the patient learns, and any difficulties will be corrected.
Once patients are observed to be performing the practice correctly, they will be asked to practice pranayama breathing exercises twice a day for 15-20 minutes for 6 weeks, accompanied by the sound of rain.
The researcher will also send a daily text message
|
|
No Intervention: standard maintenance
Rain sounds and pranayama breathing exercises will not be applied to this group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
COPD Self-Efficacy Scale
Time Frame: In the pre-test and post-test phases of the study (at the end of the sixth week), the COPD Self-Efficacy Scale will be administered to experimental groups 1 and 2 one day after the pranayama breathing exercises, and to the control group 6 weeks after the
|
COPD Self-Efficacy Scale: The COPD Self-Efficacy Scale was developed by Wigal et al. in 1991.
In Turkey, its validity and reliability were established by Kara and Mirci (2002).
The COPD Self-Efficacy Scale is a 5-point Likert-type scale consisting of 34 items and 5 sub-dimensions that determine the degree of confidence COPD patients have in managing or avoiding shortness of breath during certain activities.
The Negative Impact sub-dimension measures the degree of confidence in managing shortness of breath in stressful situations.
The Emotional State sub-dimension determines the degree of confidence in coping with shortness of breath in situations of anger, fear, and life-related distress.
The Physical Effort sub-dimension measures the level of ability to manage shortness of breath during physical activities such as climbing stairs very quickly and walking.
The Weather/Environmental Conditions sub-dimension evaluates coping with situations that may cause shortness of breath, such as co
|
In the pre-test and post-test phases of the study (at the end of the sixth week), the COPD Self-Efficacy Scale will be administered to experimental groups 1 and 2 one day after the pranayama breathing exercises, and to the control group 6 weeks after the
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serap Parlar Kılıç, Inonu University
- Study Director: Elvan Kırılmaz, Siirt University
- Study Director: Hilal Ermiş, Inonu University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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