Effects of Laura Mitchell's and Benson Relaxation Technique On Anxiety, Sleep Quality and Fatigue Among COPD Patients

NCT07635446 | Recruiting

• 1 other identifier: REC/RCR & AHS/25/0308
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Keywords

Anxiety; Benson relaxation; Fatigue; Laura Mitchell's relaxation technique; Sleep quality

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Change in Fatigue Severity Assessed by the Fatigue Severity Scale

  6 week

Study Arms (2)

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.

Behavioral: Laura Mitchell's Physiological Relaxation Technique.

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.

Behavioral: Benson Relaxation

Interventions

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.

Laura Mitchell's Physiological Relaxation Technique.

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.

Benson Relaxation

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Gender: Male and Female
• Age: 40 to 60 years
• Patients diagnosed with COPD
• Willing to participate

You may not qualify if:

• Patients with Exacerbations within past 4 weeks
• Cardiac Diseases (Acute MI, Congestive Heart Failure)
• Neuromuscular Disorder
• Recent lung diseases
• Hemodynamic instability
• Respiratory failure

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Gulab Devi Hospital

Lahore, Punjab Province, 40100, Pakistan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Anxiety Disorders; Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Arjumand Bano, MS

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Iqbal Tariq, Phd

CONTACT

333826752; iqbal.tariq@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)