- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07263828
Breath Meditation on the Older People (MEDITATION)
The Effect of a Breathing Meditation Program on Perceived Stress, Sense of Integrity, and Quality of Life in the Elderly: A Randomized Controlled Study
A decrease in physical activity during old age leads to a decline in quality of life and life satisfaction. Increased stress and anxiety levels during this period negatively affect individuals' mood and reduce their quality of life. Individuals with a strong sense of coherence cope more effectively with stress and maintain a higher quality of life. Breathing meditation is a side-effect-free and easily applicable method that reduces the effects of stress by increasing individual awareness. Mindfulness-based breathing practices contribute to mental calmness and a healthier coping with stress. Experimental studies evaluating the effects of breathing meditation on stress, sense of coherence, and quality of life in older individuals are limited in the literature. This study aimed to determine the effects of a breathing meditation program on perceived stress, sense of coherence, and quality of life in older individuals.
The study was conducted with a randomized controlled experimental design between October 2024 and September 2025 with 128 participants (63 in the experimental group and 65 in the control group). Data were collected using the Participant Information Form, the Perceived Stress Scale (PSS), the Sense of Personal Integrity Scale (SWI), and the Quality of Life Scale for the Elderly (WHOQOL-OLD). Individuals in the experimental group received a 15-minute breathing meditation session daily for 10 days. The control group received no intervention. The scales were administered as a pretest and a posttest after day 15 in both groups. Data were analyzed using SPSS software; independent and dependent sample t-tests, chi-square tests, and descriptive statistics were used, with a significance level of p<0.05.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Sinop, Turkey (Türkiye)
- Sinop University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged 65 years and above,
- who volunteered to participate,
- had no communication difficulties,
- had not previously received any training or practice related to relaxation, breathing, or stress management.
Exclusion Criteria:
- Having received any training or practice in relaxation, breathing or stress management before.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional
Individuals in the experimental group were given a 15-minute breathing meditation session every day for 10 days.
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Individuals in the experimental group were given a 15-minute breathing meditation session every day for 10 days.
|
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No Intervention: Control
No-application group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Information Form
Time Frame: Baseline- first day
|
The Participant Information Form was developed by the researchers in line with the literature and included sociodemographic characteristics such as age, gender, marital status, educational level, and living situation
|
Baseline- first day
|
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Perceived Stress Scale
Time Frame: Baseline (First day)
|
The scale consists of 14 items rated on a 5-point Likert scale ranging from 0 ("never") to 4 ("very often"), with higher scores indicating higher levels of perceived stress.
Negatively worded items are reverse-scored, and the total score ranges from 0 to 56.
|
Baseline (First day)
|
|
The Sense of Coherence Scale
Time Frame: Baseline (First day)
|
The scale consists of 13 items rated on a 7-point Likert scale, and higher scores indicate a stronger sense of coherence.
The SOC captures how individuals understand and respond to life events, their perceived ability to manage challenges, and the meaningfulness they attribute to life experiences.
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Baseline (First day)
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WHOQOL-OLD (World Health Organization Quality of Life - Older Adults Module
Time Frame: Baseline (First day)
|
Quality of life was evaluated using the WHOQOL-OLD scale, developed by the World Health Organization for older adults.
The scale includes 24 items covering six domains: sensory abilities, autonomy, past, present, and future activities, social participation, death and dying, and intimacy.
Items are scored on a 5-point Likert scale, with higher scores indicating better quality of life.
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Baseline (First day)
|
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Perceived Stress Scale
Time Frame: Post test - Fifteenth day
|
The scale consists of 14 items rated on a 5-point Likert scale ranging from 0 ("never") to 4 ("very often"), with higher scores indicating higher levels of perceived stress.
Negatively worded items are reverse-scored, and the total score ranges from 0 to 56.
|
Post test - Fifteenth day
|
|
The Sense of Coherence Scale
Time Frame: Post test - Fifteenth day
|
The scale consists of 13 items rated on a 7-point Likert scale, and higher scores indicate a stronger sense of coherence.
The SOC captures how individuals understand and respond to life events, their perceived ability to manage challenges, and the meaningfulness they attribute to life experiences.
|
Post test - Fifteenth day
|
|
WHOQOL-OLD (World Health Organization Quality of Life - Older Adults Module
Time Frame: Post test - Fifteenth day
|
Quality of life was evaluated using the WHOQOL-OLD scale, developed by the World Health Organization for older adults.
The scale includes 24 items covering six domains: sensory abilities, autonomy, past, present, and future activities, social participation, death and dying, and intimacy.
Items are scored on a 5-point Likert scale, with higher scores indicating better quality of life.
|
Post test - Fifteenth day
|
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Breath Meditation on the Older
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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