- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06822244
The Effect of Pranayama Exercise (Pranayama)
The Effect of Pranayama Exercise on Vital Signs, Anxiety, Fear of Death, and Sleep Quality After Acute Myocardial Infarction
Objective: This randomized controlled experimental study aimed to investigate the effects of pranayama exercises on vital signs, anxiety, fear of death, and sleep quality in patients who have experienced an acute myocardial infarction.
Materials and Methods: The study sample consisted of 80 patients diagnosed with acute myocardial infarction who were hospitalized in the Coronary Intensive Care Unit of Istanbul University Cerrahpaşa Medical Faculty Hospital The patients were randomly assigned to either the experimental (n=40) or control group (n=40) using a computer-based randomization method. Data collection tools included the Personal Information Form, Beck Anxiety Inventory, Death Anxiety Scale, and Pittsburgh Sleep Quality Index.
Study Overview
Status
Intervention / Treatment
Detailed Description
Objective: This randomized controlled experimental study aimed to investigate the effects of pranayama exercises on vital signs, anxiety, fear of death, and sleep quality in patients who have experienced an acute myocardial infarction.
Materials and Methods: The study sample consisted of 80 patients diagnosed with acute myocardial infarction who were hospitalized in the Coronary Intensive Care Unit of Istanbul University Cerrahpaşa Medical Faculty Hospital between June and November 2024. The patients were randomly assigned to either the experimental (n=40) or control group (n=40) using a computer-based randomization method. Data collection tools included the Personal Information Form, Beck Anxiety Inventory, Death Anxiety Scale, and Pittsburgh Sleep Quality Index.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kartal
-
İstanbul, Kartal, Turkey, 34862
- İstanbul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Voluntary participation in the study
Age ≥18 years
Diagnosed with AMI
Cognitive ability to perform pranayama exercises
Ability to comprehend and respond to survey questions
No communication impairments
Exclusion Criteria:
- having respiratory diseases
- low saturation <95
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pranayama exercise
Do Pranayama Exercise
|
The people in the pranayama experimental group were first informed about the practice (At the deepest point of the breath, the left nostril is closed with the index finger of the right hand and exhaled through the right nostril. When it reaches the deepest point, close the nostril with the thumb and exhale through the left nostril. At least 3 more rounds are continued in this way. one Pranayama session (approximately 30 minutes). The people in the experimental group were taught pranayama exercises during the application and were given a brochure with written instructions on home application and were info |
|
Active Comparator: Control
do Nothing
|
normal breathing 20 breath per min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Anxiety Inventory
Time Frame: up to 4 weeks
|
It is a Likert-type scale consisting of 21 items and scored between 0-3.
According to scale scoring; 8 points: No anxiety, 8-15 points: Mild anxiety, 16-25 points: Moderate anxiety, 26-63 points: Determined as severe anxiety decrease the15 points
|
up to 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulMU
- 00144 (Other Grant/Funding Number: medeniyet university)
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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