Aging WellNCT06712056
Effect of Mindfulness- Based Stress Reduction Program in the Elderly onSpiritual Well- Being and Meaning of Life
A study testing Mindfulness in people with Aging Well and Nursing Caries, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This quasi-experimental study with a pretest-posttest control group will be conducted to determine the effect of a mindfulness-based stress reduction program on spiritual well-being and the meaning of life among the elderly. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Well, Nursing Caries
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Oct 2022to 17 Nov 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being 65 years or older,
- Living in the nursing home where the research will be conducted,
- Being competent to continue the health education program,
- Getting at least 23 points from SMMT
- No hearing-visual impairment,
- Being literate,
- Volunteering to participate in research.
Who cannot join
- Having a communication barrier,
- Being diagnosed with dementia,
- Not having attended any session of the eight-session training program,
- Getting a score lower than 23 points from SMMT,
- Having psychosis or mental disability that may cause cognitive impairment,
- Do not have a terminal illness.
- Not having participated in any of the Pretest, Posttest-1 and Posttest-2.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing
Aydin, 09000
About this study
This quasi-experimental study with a pretest-posttest control group will be conducted to determine the effect of a mindfulness-based stress reduction program on spiritual well-being and the meaning of life among the elderly.
Read the detailed description
Aging is a natural part of the life process, during which individuals undergo numerous biological, psychological, and social changes. In this period, people often engage in reflecting on past life experiences, seeking meaning in life, and searching for a spiritual direction. At the same time, physical limitations brought about by aging, social isolation, and losses can increase stress levels in older individuals. Stress can have adverse effects on their health, including anxiety, depression, sleep problems, and overall health deterioration.
Mindfulness-Based Stress Reduction (MBSR) helps individuals develop skills to accept the present moment, cope with stress, and regulate emotions. Spiritual well-being plays a significant role in enhancing the quality of life for older adults. The MBSR program enables older individuals to consciously focus their attention on the present moment, allowing them to live more mindfully in the "here and now" instead of dwelling on past anxieties or future worries.
This study examines the effects of the MBSR program on spiritual well-being and meaning-making in older adults, highlighting the importance of spiritual support and mindfulness practices in later life. The research aims to contribute to spiritual support programs for older individuals. A hypothesis will be tested to determine whether there is a difference between the intervention and control groups after the program's implementation.
- Conditions
- Aging Well, Nursing Caries
- Being tested
- Mindfulness
- Keywords
- Mindfulness,, Nursing, Stress, Spirituality.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Also called awereneses training, breathing awareness study.
study of focusing attention
| Study group | Role | What they receive |
|---|---|---|
| Arm and İnterventional | Experimental | MBSR training will be given to this experimental group. To assess the cognitive status of the elderly, the "Standardized Mini-Mental State Examination" was used for those with primary or higher education levels, and the "Standardized Mini-Mental State Examination for the Uneducated" for those without primary education. Only elderly individuals scoring 23 or above on the Mini-Mental State Examination were included in the study. The elderly participants received mindfulness training (8 sessions), and personal questionnaire forms, the Spiritual Well-Being Scale, and the Meaning in Life Scale were administered before the intervention and post-intervention (at the 1st and 3rd months).The training is include awareness, staying in the moment, awareness of body, emotion, thought and environment, and breathing exercise techniques. Receives: Behavioral: Mindfulness |
| İnterventional | No intervention | MBRS training will not be given to this control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Mini Mental Test
In this study, elderly individuals, who scored at least 23 and at most 30 on the Standardized Mini Mental Test were included
Measured: pretraining
Survey Form
The form prepared by the reseearchers consisted of 13 questions, including personal characteristics, developed based on a literature review
Measured: pretraining
Secondary outcomes (2)
Spiritual Well Being Scale
The scale consists of 29 questions and three sub-dimensions with five-point Likert type items. A high score in each sub-dimensin indicats that the individual possesses the characteristic assessed by that sub-dimension. It is a three- factor scale, with a possible score range of 29 to 145.
Measured: post-training at the 1st and 3rd months]
Meaning in Life Scale
The scale consists of 10 questions and two sub- dimensions with seven point likert type items. The correlation coefficients between the items in Turkish and original forms range from 0.65 to 0.91.
Measured: post traninig at the 1st and 3rd months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start27 Oct 2022
- Primary completion17 Aug 2023
- Study completion17 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- quasi-experimental study with a pretest posttest controlgroup design
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Yasemin Sevimoglu, Aydin Adnan Menderes University
- Investigators
- Melek Yasemin Sevimoğlu, Study chair, Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health NursingFiliz Adana, prof, Principal investigator, Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712056
- Sponsor's protocol ID
- MYSevimoğlu
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness- Based Stress Reduction Program in the Elderly onSpiritual Well- Being and Meaning of Life
- ClinicalTrials.gov ID
- NCT06712056
- Acronym / sponsor ID
- MYSevimoğlu
- Conditions
- Aging Well, Nursing Caries
- Keywords
- Mindfulness,, Nursing, Stress, Spirituality.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 17 Nov 2024 (actual)
- First posted
- 2 Dec 2024 (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.
This quasi-experimental study with a pretest-posttest control group will be conducted to determine the effect of a mindfulness-based stress reduction program on spiritual well-being and the meaning of life among the elderly.
Detailed description
Aging is a natural part of the life process, during which individuals undergo numerous biological, psychological, and social changes. In this period, people often engage in reflecting on past life experiences, seeking meaning in life, and searching for a spiritual direction. At the same time, physical limitations brought about by aging, social isolation, and losses can increase stress levels in older individuals. Stress can have adverse effects on their health, including anxiety, depression, sleep problems, and overall health deterioration.
Mindfulness-Based Stress Reduction (MBSR) helps individuals develop skills to accept the present moment, cope with stress, and regulate emotions. Spiritual well-being plays a significant role in enhancing the quality of life for older adults. The MBSR program enables older individuals to consciously focus their attention on the present moment, allowing them to live more mindfully in the "here and now" instead of dwelling on past anxieties or future worries.
This study examines the effects of the MBSR program on spiritual well-being and meaning-making in older adults, highlighting the importance of spiritual support and mindfulness practices in later life. The research aims to contribute to spiritual support programs for older individuals. A hypothesis will be tested to determine whether there is a difference between the intervention and control groups after the program's implementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- quasi-experimental study with a pretest posttest controlgroup design
| Arm | Type | Receives |
|---|---|---|
| Arm and İnterventional | Experimental | Behavioral: MindfulnessMBSR training will be given to this experimental group. To assess the cognitive status of the elderly, the "Standardized Mini-Mental State Examination" was used for those with primary or higher education levels, and the "Standardized Mini-Mental State Examination for the Uneducated" for those without primary education. Only elderly individuals scoring 23 or above on the Mini-Mental State Examination were included in the study. The elderly participants received mindfulness training (8 sessions), and personal questionnaire forms, the Spiritual Well-Being Scale, and the Meaning in Life Scale were administered before the intervention and post-intervention (at the 1st and 3rd months).The training is include awareness, staying in the moment, awareness of body, emotion, thought and environment, and breathing exercise techniques. |
| İnterventional | No intervention | –MBRS training will not be given to this control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Being 65 years or older,
Key exclusion criteria (7 listed)
- Having a communication barrier,
- Being diagnosed with dementia,
- Not having attended any session of the eight-session training program,
- Getting a score lower than 23 points from SMMT,
- Having psychosis or mental disability that may cause cognitive impairment,
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 |
|---|---|---|
| MindfulnessAlso: awereneses training, breathing awareness study.study of focusing attention | Behavioural | Arm and İnterventional |
Primary outcome
Standardized Mini Mental Test
Time frame: pretraining
In this study, elderly individuals, who scored at least 23 and at most 30 on the Standardized Mini Mental Test were included
Survey Form
Time frame: pretraining
The form prepared by the reseearchers consisted of 13 questions, including personal characteristics, developed based on a literature review
2 secondary outcomes
Spiritual Well Being Scale
Time frame: post-training at the 1st and 3rd months]
Meaning in Life Scale
Time frame: post traninig at the 1st and 3rd months
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 2 Dec 2024.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
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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.
Melek Yasemin Sevimoğlu study chair
Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing
Filiz Adana, prof principal investigator
Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Aging Well and Nursing Caries, run by Aydin Adnan Menderes 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 7 inclusion and 7 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 2 Dec 2024. 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?
Standardized Mini Mental Test (time frame: pretraining). The study lists 2 primary outcomes in all. 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 2 Dec 2024.