Sleep Quality and Psychological Well- BeingMeditationNCT06746987
The Effect of Meditation Applied to Elderly Individulas on Sleep Quality and Psychological Well- Being
A study testing Meditation in people with Sleep Quality and Psychological Well- Being, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
It is planned as a randomized controlled experimental study to examine the effect of theta healing meditation technique on sleep quality and psychological well- being of elderly individuals. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality and Psychological Well- Being
- What is being tested?
- Meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2025to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Written and verbal permission was obtained to participate in the research, Able to communicate in Turkish, Those aged 65 and over, Those who signed the informed consent form to participate in the research, Having a Standardized Mini Mental Test (SMMT) score of 24 points and above, No perception disorder, Without psychological medical diagnoses, Those without hearing problems will be included.
Who cannot join
- Standarzide Mini Mental Test (SMMT) score below 24 points, Having a perception disorder, Those with psychological medical diagnoses, Having hearing problems, Cannot communicate in Turkish, Those who have any health problems during the application process, Those who cannot continue the research for any reason, Those who want to leave the research with their own consent will not be included in the research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Theta Healing Meditation Technique Applied to Elderly Individulas on Sleep Quality and Psychological Well- Being
It is planned as a randomized controlled experimental study to examine the effect of theta healing meditation technique on sleep quality and psychological well- being of elderly individuals.
Read the detailed description
To evaluate the effect of theta healing meditation technique on sleep quality and psychological well- being in individuals over the age of 65, a study will be conducted with a total of 34 individuals consisting of a study and control group. Analysis of the research sample size was made using the G power 3.1.9.6 program. In the study, individuals who can communicate in Turkish, have received written and verbal permission to participate in the research, are over 65 years old, have a score of 24 or more on the Standardized Mini Mental Test (SMMT), have no preception disorder, and have no hearing problems will be included in the study. İndividuals who meet the research criteria for members of retirement homes will be included in the research. Sample selection will be completed in accordance with the study' s inclusion, axclusion criteria, followed by randomization. Individuals will be informed about the purpose of the research and the the research process, and the patient individuals will be given the ''Informed Voluntary Consent Form'' and ''Patient Introduction Form'', ''Pittsburg Sleep Quality Scale'' and ''Psychological Well- Being Scale (PERMA)'' as pre- tests, face to face, will be filled.Theta healing technique and meditation, visualization and thinking practice will be applied to the elderly individuals in the study group face to face under the guidance of the researcher for 20 minutes, 2 days a week, for 4 weeks.There will be no intervention in the control group for a 4 week period. After the 4- week theta healing meditation application is completed with the study group,''Pittsburg Sleep Quality Scale'' and ''Psychological Well- Being Scale (PERMA)'' scales will be applied to the study and control groups as a final test. The research will be competed by statistical analysis and reporting of the data obtained from the research.
- Being tested
- Meditation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationOther
After the appropriate sample group for the research is created, study and control groups will be determined. Firstly, randomization of the study and control groups in the research will be done by an independent researcher on the randomizer.org website. Secondly, the Pitsburg Sleep Quality Scale and PERMA test will be applied to the study and control groups as a pre- test. Thirdly, theta healing meditation will be applied to the study group for 4 weeks, 2 days a week, 15- 30 minutes a day. After the 4 week meditation practice is completed with the study group, a final test will be given to the study and control groupsthe Pitsburg Sleep Quality Scale and PERMA test will be applied as the final test.
| Study group | Role | What they receive |
|---|---|---|
| Meditation | Experimental | Study and control groups will be determined. Firstly, randomization of the study and control groups in the research will be done by an independent researcher on the randomizer.org website. Secondly, the Pitsburg Sleep Quality Scale and PERMA test will be applied to the study and control groups as a pre- test. Thirdly, theta healing meditation will be applied to the study group for 4 weeks, 2 days a week, 15- 30 minutes a day. After the 4 week meditation practice is completed with the study group, a final test will be given to the study and control groupsthe Pitsburg Sleep Quality Scale and PERMA test will be applied as the final test. Receives: Other: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of theta healing meditation on sleep quality will be evaluated with the Pittsburg Sleep Quality Scale.
The Pittsburg Sleep Quality, which examines the individual' s sleep quality in the last month, consists of 24 items. 24 items in the scale; It consists of 19 self- report questions answered by the individual and five questions answered or spouse and are not included and are not included in the scoring instructions and are used only for clinical information. Self- report questions included in the scoring consist of 7 components. These components; It provides information about subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency sleep disturbance, use of sleeping pills, and daytime sleep dysfunction. Each question is evaluated with a number from 0 to 3. The highest score that can be obtained from the scale is 21. An increase in the score obtained from the scale indicates that sleep quality is poor.
Measured: The change before theta healing meditation and after 4 weeks of meditation lasting 15- 30 minutes, 2 days a week.
Secondary outcomes (1)
The effect of theta healing meditation on psychological well- being will be evaluated with the Psychological Well- Being Scale.
Psychological Well- Being Scale five dimensions include positive emotions, positive emotions, positive relationships, meaning, achievement and connection. It is found bu taking the average.
Measured: The change before theta healing meditation and after 4 weeks of meditation lasting 15- 30 minutes, 2 days a week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start27 Jan 2025 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Quality and Psychological Well- BeingStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Randomized controlled experimental clinical trial with pre- test and post- test measurements consisting of a study and control group.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazmiye UĞUR, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746987
- Sponsor's protocol ID
- MersinUUU
- Acronym
- Meditation
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Theta Healing Meditation Technique Applied to Elderly Individulas on Sleep Quality and Psychological Well- Being
- ClinicalTrials.gov ID
- NCT06746987
- Acronym / sponsor ID
- Meditation / MersinUUU
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 27 Jan 2025 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Mar 2025 (estimated)
- First posted
- 24 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.
It is planned as a randomized controlled experimental study to examine the effect of theta healing meditation technique on sleep quality and psychological well- being of elderly individuals.
Detailed description
To evaluate the effect of theta healing meditation technique on sleep quality and psychological well- being in individuals over the age of 65, a study will be conducted with a total of 34 individuals consisting of a study and control group. Analysis of the research sample size was made using the G power 3.1.9.6 program. In the study, individuals who can communicate in Turkish, have received written and verbal permission to participate in the research, are over 65 years old, have a score of 24 or more on the Standardized Mini Mental Test (SMMT), have no preception disorder, and have no hearing problems will be included in the study. İndividuals who meet the research criteria for members of retirement homes will be included in the research. Sample selection will be completed in accordance with the study' s inclusion, axclusion criteria, followed by randomization. Individuals will be informed about the purpose of the research and the the research process, and the patient individuals will be given the ''Informed Voluntary Consent Form'' and ''Patient Introduction Form'', ''Pittsburg Sleep Quality Scale'' and ''Psychological Well- Being Scale (PERMA)'' as pre- tests, face to face, will be filled.Theta healing technique and meditation, visualization and thinking practice will be applied to the elderly individuals in the study group face to face under the guidance of the researcher for 20 minutes, 2 days a week, for 4 weeks.There will be no intervention in the control group for a 4 week period. After the 4- week theta healing meditation application is completed with the study group,''Pittsburg Sleep Quality Scale'' and ''Psychological Well- Being Scale (PERMA)'' scales will be applied to the study and control groups as a final test. The research will be competed by statistical analysis and reporting of the data obtained from the research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomized controlled experimental clinical trial with pre- test and post- test measurements consisting of a study and control group.
| Arm | Type | Receives |
|---|---|---|
| Meditation | Experimental | Other: MeditationStudy and control groups will be determined. Firstly, randomization of the study and control groups in the research will be done by an independent researcher on the randomizer.org website. Secondly, the Pitsburg Sleep Quality Scale and PERMA test will be applied to the study and control groups as a pre- test. Thirdly, theta healing meditation will be applied to the study group for 4 weeks, 2 days a week, 15- 30 minutes a day. After the 4 week meditation practice is completed with the study group, a final test will be given to the study and control groupsthe Pitsburg Sleep Quality Scale and PERMA test will be applied as the final test. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Written and verbal permission was obtained to participate in the research, Able to communicate in Turkish, Those aged 65 and over, Those who signed the informed consent form to participate in the research, Having a Standardized Mini Mental Test (SMMT) score of 24 points and above, No perception disorder, Without psychological medical diagnoses, Those without hearing problems will be included.
Key exclusion criteria (1 listed)
- Standarzide Mini Mental Test (SMMT) score below 24 points, Having a perception disorder, Those with psychological medical diagnoses, Having hearing problems, Cannot communicate in Turkish, Those who have any health problems during the application process, Those who cannot continue the research for any reason, Those who want to leave the research with their own consent will not be included in the research.
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 |
|---|---|---|
| MeditationAfter the appropriate sample group for the research is created, study and control groups will be determined. Firstly, randomization of the study and control groups in the research will be done by an independent researcher on the randomizer.org website. Secondly, the Pitsburg Sleep Quality Scale and PERMA test will be applied to the study and control groups as a pre- test. Thirdly, theta healing meditation will be applied to the study group for 4 weeks, 2 days a week, 15- 30 minutes a day. After the 4 week meditation practice is completed with the study group, a final test will be given to the study and control groupsthe Pitsburg Sleep Quality Scale and PERMA test will be applied as the final test. | Other | Meditation |
Primary outcome
The effect of theta healing meditation on sleep quality will be evaluated with the Pittsburg Sleep Quality Scale.
Time frame: The change before theta healing meditation and after 4 weeks of meditation lasting 15- 30 minutes, 2 days a week.
The Pittsburg Sleep Quality, which examines the individual' s sleep quality in the last month, consists of 24 items. 24 items in the scale; It consists of 19 self- report questions answered by the individual and five questions answered or spouse and are not included and are not included in the scoring instructions and are used only for clinical information. Self- report questions included in the scoring consist of 7 components. These components; It provides information about subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency sleep disturbance, use of sleeping pills, and daytime sleep dysfunction. Each question is evaluated with a number from 0 to 3. The highest score that can be obtained from the scale is 21. An increase in the score obtained from the scale indicates that sleep quality is poor.
1 secondary outcome
The effect of theta healing meditation on psychological well- being will be evaluated with the Psychological Well- Being Scale.
Time frame: The change before theta healing meditation and after 4 weeks of meditation lasting 15- 30 minutes, 2 days a week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: Yes
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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.
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 Meditation in people with Sleep Quality and Psychological Well- Being, run by Mersin 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 24 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?
This study is still under way. Results are not available in the source record yet.
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?
The effect of theta healing meditation on sleep quality will be evaluated with the Pittsburg Sleep Quality Scale. (time frame: The change before theta healing meditation and after 4 weeks of meditation lasting 15- 30 minutes, 2 days a week.). 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 24 Dec 2024.