- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07635446
Effects of Laura Mitchell's and Benson Relaxation Technique On Anxiety, Sleep Quality and Fatigue Among COPD Patients
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Muhammad Iqbal Tariq, pHD
- Número de teléfono: 333826752
- Correo electrónico: iqbal.tariq@riphah.edu.pk
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 40100
- Reclutamiento
- Gulab Devi hospital
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Contacto:
- Nimra noor, MS-CPPT
- Número de teléfono: 0303068469
- Correo electrónico: nimranoor358@gmail.com
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Contacto:
- Muqadas Mehmood, MS-CPPT
- Número de teléfono: 03000618006
- Correo electrónico: muqadasmehmood66@gmail.com
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Investigador principal:
- Nimra Noor, MS-CPPT
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Gender: Male and Female
- Age: 40 to 60 years
- Patients diagnosed with COPD
- Willing to participate
Exclusion Criteria:
Patients with Exacerbations within past 4 weeks
- Cardiac Diseases (Acute MI, Congestive Heart Failure)
- Neuromuscular Disorder
- Recent lung diseases
- Hemodynamic instability
- Respiratory failure
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Laura Mitchell's Physiological Relaxation Technique.
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. |
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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Comparador activo: Benson Relaxation
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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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Anxiety Severity Assessed by the Generalized Anxiety Disorder-7
Periodo de tiempo: 6 week
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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.
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6 week
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Pitts burg Sleep Quality index
Periodo de tiempo: 6 week
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Fatigue Severity Assessed by the Fatigue Severity Scale
Periodo de tiempo: 6 week
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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. |
6 week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arjumand Bano, MS, Riphah International University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades Pulmonares Obstructivas
- Trastornos del sueño y la vigilia
- Trastornos del Sueño Intrínsecos
- Disomnias
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedad Pulmonar Obstructiva Crónica
- Desórdenes de ansiedad
- Fatiga
- Trastornos de iniciación y mantenimiento del sueño
Otros números de identificación del estudio
- REC/RCR & AHS/25/0308
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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