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NCT Number: 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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Anxiety Severity Assessed by the Generalized Anxiety Disorder-7

    Time frame: 6 week

    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.

  2. Pitts burg Sleep Quality index

    Time frame: 6 week

    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.

Secondary outcomes

  1. Change in Fatigue Severity Assessed by the Fatigue Severity Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Iqbal Tariq, Phd

CONTACT

[email protected]

333826752

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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