- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07729267
Effect of Simha Pranayama and Bhramari Pranayama Relaxation Technique on Sleep and Quality of Life
Comparative Effects of Simha Pranayama (Lion's Breath) and Bhramari Pranayama (Humming Bee Breath) Yogic Relaxation Techniques on Sleep and Quality of Life Among Healthy Adults
Day end work related mental and muscular tension is quite common among young healthy individuals. This tension dramatically disturb sleeping pattern which also effects QoL. For this, two breathing relaxation yoga techniques namely Simha Pranayama and Bhramari Pranayama have been compared.
The study aims to compare the effects of Simha Pranayama and Bhramari Pranayama on sleep and QoL among healthy adult individuals.
It was a randomized clinical trial. Sample size of 68 was calculated by keeping 95% confidence interval and 0.05 margin of error. Subjects were selected through convenient sampling technique and then allocated by simple randomization process through sealed opaque envelope into Group A (Simha Pranayama) or Group B (Bhramari Pranayama). Subjects perform yoga techniques for 1 month. A booklet and recorded video was provided to read and follow the steps. Pre-treatment assessment was done before start of yoga therapy. Post treatment evaluation was done by assessing sleep through Pittsburgh Sleep Quality Index Questionnaire and QoL via SF-36 Questionnaire.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Lahore city
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Both male and female active working class
Exclusion Criteria:
acute asthmatic attack in last one month cough active hemoptysis cardiac instability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Simha Pranayama Relaxation Technique
34 healthy adults will perform Simha Pranayama and their sleep and quality of life will be accessed
|
|
|
Active Comparator: Bhramari Pranayama Relaxation technique
34 healthy adults will perform Bhramari Pranayama and their sleep and quality of life will be accessed
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical function
Time Frame: End of 4 weeks
|
Short Form-36 Health Survey (SF-36) questionnaire.
The questionnaire assesses health-related quality of life across eight domains.
Each domain is transformed to a 0-100 scale, where 0 represents the worst possible health status and 100 represents the best possible health status.
Higher scores indicate better health-related quality of life.
|
End of 4 weeks
|
|
Sleep
Time Frame: End of 4 weeks
|
The Pittsburgh Sleep Quality Index (PSQI) is a standardized self-report questionnaire developed to assess subjective sleep quality.
It consists of 19 self-rated items, which are combined into 7 component scores.
Outcome Measure: Pittsburgh Sleep Quality Index .
It is a validated self-administered questionnaire that assesses subjective sleep quality over the preceding month.
It comprises 19 self-rated items grouped into seven components, each scored from 0 to 3. The component scores are summed to obtain a global score ranging from 0 to 21, where 0 represents the best sleep quality and 21 represents the poorest sleep quality.
A global score greater than 5 is indicative of poor sleep quality and clinically significant sleep disturbance.
|
End of 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohtishim Ahmed, MSPT, DPT, Green International University, Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GIU/REC/26-61
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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