PranayamaPranayamaNCT06822244
The Effect of Pranayama Exercise
A study testing Pranayama exercise and normal breathing in people with Pranayama and Exercise, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Pranayama exercise and normal breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2023to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- having respiratory diseases
- low saturation <95
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Pranayama exercise, normal breathing
- Keywords
- pranayama, Exercise, Anxiety, Death, Sleep
- Medical subject headings
- Motor Activity, Anxiety Disorders, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pranayama exerciseBehavioural
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
normal breathingBehavioural
normal breathing 20 breath per min
| Study group | Role | What they receive |
|---|---|---|
| Pranayama exercise | Experimental | Do Pranayama Exercise Receives: Behavioral: Pranayama exercise |
| Control | Active comparator | do Nothing Receives: Behavioral: normal breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory
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
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start20 Dec 2023
- Primary completion23 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PranayamaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Assuming a power of 80% and an α risk of. 05, a sample size of 75 was determined to be appropriate. Considering the possibility of missing data, the study initially included 80 participants in both the experimental and control groups. A computer-based random number generator was used for group assignment, and allocation concealment was ensured by using sealed envelopes containing random numbers opened by a separate researcher. The study was completed with 40 participants in the experimental group and 40 in the control group, due to some participants withdrawing.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Dincer, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822244
- Sponsor's protocol ID
- IstanbulMU
- Other IDs
- 00144
- Acronym
- Pranayama
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 12 Feb 2025
- 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pranayama Exercise on Vital Signs, Anxiety, Fear of Death, and Sleep Quality After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06822244
- Acronym / sponsor ID
- Pranayama / IstanbulMU
- Keywords
- pranayama, Exercise, Anxiety, Death, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 23 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 12 Feb 2025 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Assuming a power of 80% and an α risk of. 05, a sample size of 75 was determined to be appropriate. Considering the possibility of missing data, the study initially included 80 participants in both the experimental and control groups. A computer-based random number generator was used for group assignment, and allocation concealment was ensured by using sealed envelopes containing random numbers opened by a separate researcher. The study was completed with 40 participants in the experimental group and 40 in the control group, due to some participants withdrawing.
| Arm | Type | Receives |
|---|---|---|
| Pranayama exercise | Experimental | Behavioral: Pranayama exerciseDo Pranayama Exercise |
| Control | Active comparator | Behavioral: normal breathingdo Nothing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- having respiratory diseases
- low saturation <95
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 |
|---|---|---|
| Pranayama exerciseThe 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 | Behavioural | Pranayama exercise |
| normal breathingnormal breathing 20 breath per min | Behavioural | Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama exercise and normal breathing in people with Pranayama and Exercise, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 12 Feb 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (time frame: up to 4 weeks). 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 12 Feb 2025.