NCT06746987

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 27, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

1 month

First QC Date

December 18, 2024

Last Update Submit

December 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    The change before theta healing meditation and after 4 weeks of meditation lasting 15- 30 minutes, 2 days a week.

Study Arms (1)

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.

Other: Meditation

Interventions

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.

Meditation

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey, Mersin University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersPsychological Well-Being

Interventions

Meditation

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
A single blind technique will be used in the research. Thus, it will not be known to the subjects whether the research participants are in the study or control groups. When the research is completed, the data of the study and control groups will be transferred to the computer environment by a researcher independent of the research, and the data will be analyzed by a statisitcian and the findings will ve reported.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Randomized controlled experimental clinical trial with pre- test and post- test measurements consisting of a study and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mersin University Nursing PhD Student

Study Record Dates

First Submitted

December 18, 2024

First Posted

December 24, 2024

Study Start

January 27, 2025

Primary Completion

February 28, 2025

Study Completion

March 28, 2025

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Locations