The Effect of Pranayama Exercise

NCT06822244 | Completed

• 2 other identifiers: IstanbulMU00144
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pranayama; Exercise; Anxiety; Death; Sleep

Keywords

pranayama; Exercise; Anxiety; Death; Sleep

Outcome Measures

Primary Outcomes (1)

• 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

  up to 4 weeks

Study Arms (2)

Pranayama exercise

EXPERIMENTAL

Do Pranayama Exercise

Behavioral: Pranayama exercise

Control

ACTIVE COMPARATOR

do Nothing

Behavioral: normal breathing

Interventions

Pranayama exercise BEHAVIORAL

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

Pranayama exercise

normal breathing BEHAVIORAL

normal breathing 20 breath per min

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• having respiratory diseases
• low saturation \<95

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

İstanbul

Istanbul, Kartal, 34862, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Anxiety Disorders; Death

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 12, 2025
• Study Start: December 20, 2023
• Primary Completion: November 23, 2024
• Study Completion: December 20, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)