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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
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.Research Hospitalization in Ankara City Hospital Neurology Intensive Care It will be done with individuals who have chronic diseases in the 65-85 age range. Research It is planned to be held between November 2021 and December 2022.Therapeutic touch will be applied to the patients selected in the experimental and control groups among the patients who meet the research criteria in the intensive care units. After this application, the sleep pattern changes in the patients will be evaluated.Therapeutic touch will be applied to the patients selected in the experimental and control groups among the patients who meet the research criteria in the intensive care units. After this application, sleep pattern changes in patients will be evaluated. In the analysis of the research, dependent groups t test andindependent groups t test, Mann Whitney U and Kruskal Wallis tests will be used in non-parametric cases
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The effect of therapeutic touch on sleep patterns of elderly patients | Experimental | The important effects of the therapeutic approach made by the researcher to the elderly patients hospitalized in the intensive care unit will be evaluated. |
|
| Determining the sleep pattern of the Control Group | No Intervention | It will be evaluated whether there is a change in sleep patterns without intervention in the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic touch | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | 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. | pretest (Measurements taken during the initial consultation) |
| Comparison of Sleep Duration and Sleep Onset Difficulties by Group at Measurement Times (Sleep Duration) | In this measurement, the sleep duration was recorded as subjective data by the researcher. (Calculated based on the intended bedtime and wake-up time) | pretest (Measurements taken during the initial consultation) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berna Bayır | KTO Karatay University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berna Bayır | Karatay | Konya | 42020 | Turkey (Türkiye) |
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Inclusion Criteria; Between 65 and 85 years of age according to the WHO classification of 1998, The patient was hospitalised in the orthopaedics and traumatology service for at least seven days, The patient is able to communicate.
Exclusion Criteria; The presence of a hearing impairment, Intubation, In the acute pain period
The population of the study consisted of 368 patients aged 65-85 years who applied to the clinic within one year. The sample size of the study was calculated by G-power analysis. The sample consisted of 68 patients, 34 in the experimental group and 34 in the control group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | Therapeutic touch was administered to this group. |
| FG001 | Control Group | No intervention was administered to this group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No different from the assignment in the Participant Flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | Therapeutic touch was administered to this group. |
| BG001 | Control Group | No intervention was administered to this group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Scale | 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. | The analysis included only participants who completed the intervention according to the study protocol. | Posted | Mean | Standard Deviation | score on a scale | pretest (Measurements taken during the initial consultation) |
|
three weeks
The definitions of adverse events and serious adverse events used in this study were consistent with the ClinicalTrials.gov definitions.
Adverse events were monitored throughout the study period through participant self-report and clinical observation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group | Therapeutic touch was administered to this group. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Berna BAYIR | KTO Karatay University | 05065422424 | 7848 | berna.bayir@karatay.edu.tr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2021 | Feb 27, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D019124 | Therapeutic Touch |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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|
| Comparison of Sleep Duration and Sleep Onset Difficulties by Group at Measurement Times (Sleep Duration) | In this measurement, the sleep duration was recorded as subjective data by the researcher. (Calculated based on the intended bedtime and wake-up time) | posttest (three weeks after the pre-test) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total Count of Participants | Count of Participants | Participants |
|
No intervention was administered to this group. |
|
|
|
| Primary | Comparison of Sleep Duration and Sleep Onset Difficulties by Group at Measurement Times (Sleep Duration) | In this measurement, the sleep duration was recorded as subjective data by the researcher. (Calculated based on the intended bedtime and wake-up time) | The analysis included only participants who completed the intervention according to the study protocol | Posted | Mean | Standard Deviation | hours | pretest (Measurements taken during the initial consultation) |
|
|
|
|
| Secondary | Visual Analogue Scale | 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. | The analysis included only participants who completed the intervention according to the study protocol. | Posted | Mean | Standard Deviation | score on a scale | posttest (three weeks after the pre-test) |
|
|
|
|
| Secondary | Comparison of Sleep Duration and Sleep Onset Difficulties by Group at Measurement Times (Sleep Duration) | In this measurement, the sleep duration was recorded as subjective data by the researcher. (Calculated based on the intended bedtime and wake-up time) | Posted | Mean | Standard Deviation | hours | posttest (three weeks after the pre-test) |
|
|
|
|
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Control Group | No intervention was administered to this group. | 0 | 34 | 0 | 34 | 0 | 34 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |