- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Muhammad Iqbal Tariq, pHD
- Numéro de téléphone: 333826752
- E-mail: iqbal.tariq@riphah.edu.pk
Lieux d'étude
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Punjab Province
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Lahore, Punjab Province, Pakistan, 40100
- Recrutement
- Gulab Devi hospital
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Contact:
- Nimra noor, MS-CPPT
- Numéro de téléphone: 0303068469
- E-mail: nimranoor358@gmail.com
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Contact:
- Muqadas Mehmood, MS-CPPT
- Numéro de téléphone: 03000618006
- E-mail: muqadasmehmood66@gmail.com
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Chercheur principal:
- Nimra Noor, MS-CPPT
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Anxiety Severity Assessed by the Generalized Anxiety Disorder-7
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Fatigue Severity Assessed by the Fatigue Severity Scale
Délai: 6 week
|
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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Arjumand Bano, MS, Riphah International University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Les troubles mentaux
- Processus pathologiques
- Maladie chronique
- Attributs de la maladie
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies pulmonaires obstructives
- Troubles du sommeil et de l'éveil
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Maladie pulmonaire obstructive chronique
- Troubles anxieux
- Fatigue
- Troubles de l'initiation et du maintien du sommeil
Autres numéros d'identification d'étude
- REC/RCR & AHS/25/0308
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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