- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05363787
The Effect of Therapeutic Touch on Sleep and Anxiety
The Effect of Therapeutic Touch on Perceived Sleep Level and Anxiety in Hospitalised Individuals Aged 65-85 Years
The aim of this study is to determine the effect of the therapeutic touch applied to the sleep patterns of individuals aged 65-85 years with chronic diseases who are treated in the Neurology Intensive Care Unit of Ankara City Hospital, taking into account the circadian cycle.The type of the research is the experimental model with pre-test and post-test control group.Ankara City Hospital has included the research population in the last year.
It will consist of 1593 patients between the ages of 65-85 who are hospitalized in the Neurology Intensive Care Unit.Experimental and control groups will be created with simple randomization in randomization.The data were obtained from the socio-demographic characteristics form and the sleep pattern form developed by the researcher.
will be collected with
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Konya
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Karatay, Konya, Turkey (Türkiye), 42020
- Berna Bayır
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being in the age range of 65-85 years
- Having a Chronic Disease
- The patient is receiving treatment at the hospital
Exclusion Criteria:
- Not in the age range of 65-85 years
- Not being able to communicate (being intubated, having hearing impairment, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: The effect of therapeutic touch on sleep patterns of elderly patients
The important effects of the therapeutic approach made by the researcher to the elderly patients hospitalized in the intensive care unit will be evaluated.
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Therapeutic Touch (TT) is an evidence-based holistic treatment method in which universal energy is used intentionally and with compassion for a specific purpose, in order to contribute to one's balance and recovery.In a world dominated by technology, one can lose touch with our inner self.
We lose our intuitive abilities for beautiful everyday sensations of nature, the surrounding environment, and various visual and auditory elements.
The Therapeutic Touch is an ancient Ayurvedic self-massage technique that connects your body to your soul.It is also used in therapeutic communication.
Therapeutic communication is the process of influencing and being influenced by one another.
It consists of individual-centered, purposeful, planned, effective and satisfying actions.
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No Intervention: Determining the sleep pattern of the Control Group
It will be evaluated whether there is a change in sleep patterns without intervention in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analogue Scale
Time Frame: pretest (Measurements taken during the initial consultation)
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The Visual Analogue Scale - Anxiety Subtest (VAS-Anxiety) was used to measure anxiety levels.
Scores ranged from 0 to 100, where 0 represents no anxiety and 100 represents the highest possible anxiety.
Higher scores indicate a worse outcome.
Patients marked their anxiety level on the scale, and this score was recorded as the outcome measure.
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pretest (Measurements taken during the initial consultation)
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Comparison of Sleep Duration and Sleep Onset Difficulties by Group at Measurement Times (Sleep Duration)
Time Frame: pretest (Measurements taken during the initial consultation)
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In this measurement, the sleep duration was recorded as subjective data by the researcher.
(Calculated based on the intended bedtime and wake-up time)
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pretest (Measurements taken during the initial consultation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: posttest (three weeks after the pre-test)
|
The Visual Analogue Scale - Anxiety Subtest (VAS-Anxiety) was used to measure anxiety levels.
Scores ranged from 0 to 100, where 0 represents no anxiety and 100 represents the highest possible anxiety.
Higher scores indicate a worse outcome.
Patients marked their anxiety level on the scale, and this score was recorded as the outcome measure.
|
posttest (three weeks after the pre-test)
|
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Comparison of Sleep Duration and Sleep Onset Difficulties by Group at Measurement Times (Sleep Duration)
Time Frame: posttest (three weeks after the pre-test)
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In this measurement, the sleep duration was recorded as subjective data by the researcher.
(Calculated based on the intended bedtime and wake-up time)
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posttest (three weeks after the pre-test)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Berna Bayır, KTO Karatay University
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Health Behavior
- Sleep Wake Disorders
- Treatment Adherence and Compliance
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Therapeutic Touch
Other Study ID Numbers
- KaratayUBS
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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