COPDNCT07635446
Effects of Laura Mitchell's and Benson Relaxation Technique On Anxiety, Sleep Quality and Fatigue Among COPD Patients
A study testing Laura Mitchell's Physiological Relaxation Technique. and Benson Relaxation in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- COPD
- What is being tested?
- Laura Mitchell's Physiological Relaxation Technique. and Benson Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Gender: Male and Female
- Age: 40 to 60 years
- Patients diagnosed with COPD
- Willing to participate
Who cannot join
- Patients with Exacerbations within past 4 weeks
- Cardiac Diseases (Acute MI, Congestive Heart Failure)
- Neuromuscular Disorder
- Recent lung diseases
- Hemodynamic instability
- Respiratory failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Gulab Devi Hospital
Lahore, Punjab Province, 40100
Nimra noor, MS-CPPT, 0303068469, nimranoor358@gmail.com
Muqadas Mehmood, MS-CPPT, 03000618006, muqadasmehmood66@gmail.com
About this study
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
- Being tested
- Laura Mitchell's Physiological Relaxation Technique., Benson Relaxation
- Keywords
- Anxiety, Benson relaxation, Fatigue, Laura Mitchell's relaxation technique, Sleep quality
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laura Mitchell's Physiological Relaxation Technique.Behavioural
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 RelaxationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Benson Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 week
Secondary outcomes (1)
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjumand Bano, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635446
- Sponsor's protocol ID
- REC/RCR & AHS/25/0308
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laura Mitchell's and Benson Relaxation Technique On Anxiety, Sleep Quality and Fatigue Among COPD Patients
- ClinicalTrials.gov ID
- NCT07635446
- Acronym / sponsor ID
- REC/RCR & AHS/25/0308
- Conditions
- COPD
- Keywords
- Anxiety, Benson relaxation, Fatigue, Laura Mitchell's relaxation technique, Sleep quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laura Mitchell's Physiological Relaxation Technique. | Experimental | Behavioral: 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. |
| Benson Relaxation | Active comparator | Behavioral: Benson RelaxationThe 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gender: Male and Female
- Age: 40 to 60 years
- Patients diagnosed with COPD
- Willing to participate
Key exclusion criteria (6 listed)
- Patients with Exacerbations within past 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Laura Mitchell's Physiological Relaxation Technique. |
| Benson RelaxationThe 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. | Behavioural | Benson Relaxation |
Primary outcome
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.
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.
1 secondary outcome
Change in Fatigue Severity Assessed by the Fatigue Severity Scale
Time frame: 6 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arjumand Bano, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laura Mitchell's Physiological Relaxation Technique. and Benson Relaxation in people with COPD, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Iqbal Tariq, Phd (333826752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Severity Assessed by the Generalized Anxiety Disorder-7 (time frame: 6 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.