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Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung condition characterized by persistent respiratory symptoms and airflow limitation. Patients with COPD often experience not only physical symptoms like breathlessness and fatigue but also psychological issues such as anxiety and poor sleep quality, which further compromise their quality of life. Non-pharmacological interventions, especially relaxation techniques, have shown promise in improving psychological well-being and physiological outcomes in COPD patients. Among these, Laura Mitchell's relaxation technique and Benson's relaxation response have gained attention for their simplicity and effectiveness.
The primary objective of this study is to assess and compare the effects of Laura Mitchell's relaxation technique and Benson's relaxation technique on anxiety, sleep quality, and fatigue levels in patients diagnosed with moderate to severe COPD. By evaluating these parameters, the study aims to determine which method provides greater benefits in managing psychological and physical symptoms associated with COPD. The study will use a randomized experimental design. Participants will be randomly assigned into two groups: Group A will receive Laura Mitchell's relaxation training, and Group B will receive Benson's technique. Both interventions will be practiced daily for 15-20 minutes over a 6-weeks period. Baseline and post-intervention (week 6) data will be collected. Outcome measures will include anxiety (GAD-7), fatigue (FSS) and sleep quality (PSQI). Data will be analyzed using paired and independent t-tests to assess within-group and between-group differences, with significance set at p < 0.05. The data will be analyzed using SPSS v 25.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laura Mitchell's Physiological Relaxation Technique. | Experimental | This technique involves awareness of postural alignment, controlled muscular tension-release, and slow rhythmic breathing. Participants will then be instructed to perform the technique daily for 15-20 minutes over a period of 6 weeks at home. Each participant will maintain a daily logbook recording the time, duration, and any feedback regarding their practice. |
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| Benson Relaxation | Active Comparator | The session will include instruction on deep breathing, mental repetition of a calming word or phrase (e.g., "relax" or "one"), and passive redirection of attention away from distracting thoughts. Participants will then practice the technique daily for 15-20 minutes for 6 weeks in a quiet environment. Each participant will also maintain a daily practice logbook. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laura Mitchell's Physiological Relaxation Technique. | Behavioral | This technique involves awareness of postural alignment, controlled muscular tension-release, and slow rhythmic breathing. Participants will then be instructed to perform the technique daily for 15-20 minutes over a period of 6 weeks at home. Each participant will maintain a daily logbook recording the time, duration, and any feedback regarding their practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety Severity Assessed by the Generalized Anxiety Disorder-7 | The Generalized Anxiety Disorder-7 (GAD-7) questionnaire will be used to assess anxiety severity. Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. The change in GAD-7 score from baseline to 6 weeks will be evaluated. | 6 week |
| Pitts burg Sleep Quality index | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a standardized self-reported questionnaire that evaluates sleep quality and sleep disturbances over the previous month. The PSQI consists of 19 self-rated items grouped into seven components, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Score Range: 0-21 Higher scores indicate poorer sleep quality and greater sleep disturbance, whereas lower scores indicate better sleep quality. A global PSQI score greater than 5 is indicative of poor sleep quality. | 6 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue Severity Assessed by the Fatigue Severity Scale | Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a standardized self-reported questionnaire that evaluates the impact of fatigue on daily functioning and activities. The FSS consists of 9 items, each rated on a 7-point Likert scale, with responses ranging from 1 (strong disagreement) to 7 (strong agreement). The final score is calculated as the mean of the 9 items. Score Range: 1-7 (mean score) Higher scores indicate greater fatigue severity and a greater impact of fatigue on daily activities, whereas lower scores indicate less fatigue. A mean score of 4 or higher is commonly considered indicative of significant fatigue. |
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Inclusion Criteria:
- Gender: Male and Female
Exclusion Criteria:
Patients with Exacerbations within past 4 weeks
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Iqbal Tariq, Phd | Contact | 333826752 | iqbal.tariq@riphah.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Arjumand Bano, MS | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulab Devi Hospital | Recruiting | Lahore | Punjab Province | 40100 | Pakistan |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001008 | Anxiety Disorders |
| D005221 | Fatigue |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Participants will be randomly assigned into two groups: Group A will receive Laura Mitchell's relaxation training, and Group B will receive Benson's technique. Both interventions will be practiced daily for 15-20 minutes over a 6-weeks period. Baseline and post-intervention (week 6) data will be collected.
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None (Open Label) Because of the physical nature of the interventions, both participants and investigators will know which treatment is being given. No blinding will be applied.
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| Benson Relaxation | Behavioral | The session will include instruction on deep breathing, mental repetition of a calming word or phrase (e.g., "relax" or "one"), and passive redirection of attention away from distracting thoughts. Participants will then practice the technique daily for 15-20 minutes for 6 weeks in a quiet environment. Each participant will also maintain a daily practice logbook. |
|
| 6 week |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |