Therapeutic AdherenceNCT05363787
The Effect of Therapeutic Touch on Sleep and Anxiety
A study testing therapeutic touch in people with Therapeutic Adherence and Nurse-Patient Relations, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Therapeutic Adherence, Nurse-Patient Relations, Sleep Disorder
- What is being tested?
- therapeutic touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Being in the age range of 65-85 years
- Having a Chronic Disease
- The patient is receiving treatment at the hospital
Who cannot join
- Not in the age range of 65-85 years
- Not being able to communicate (being intubated, having hearing impairment, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
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
- Being tested
- therapeutic touch
- Medical subject headings
- Treatment Adherence and Compliance, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic touchOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: therapeutic touch |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: pretest (Measurements taken during the initial consultation)
Secondary outcomes (2)
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.
Measured: posttest (three weeks after the pre-test)
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)
Measured: posttest (three weeks after the pre-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start5 Sep 2022
- Primary completion23 Jan 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Therapeutic AdherenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Bayır, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363787
- Sponsor's protocol ID
- KaratayUBS
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2022
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Touch on Perceived Sleep Level and Anxiety in Hospitalised Individuals Aged 65-85 Years
- ClinicalTrials.gov ID
- NCT05363787
- Acronym / sponsor ID
- KaratayUBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The effect of therapeutic touch on sleep patterns of elderly patients | Experimental | Other: therapeutic touchThe 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Being in the age range of 65-85 years
- Having a Chronic Disease
- The patient is receiving treatment at the hospital
Key exclusion criteria (2 listed)
- Not in the age range of 65-85 years
- Not being able to communicate (being intubated, having hearing impairment, etc.)
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 |
|---|---|---|
| therapeutic touchTherapeutic 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. | Other | The effect of therapeutic touch on sleep patterns of elderly patients |
Primary outcome
Visual Analogue Scale
Time frame: pretest (Measurements taken during the initial consultation)
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.
Comparison of Sleep Duration and Sleep Onset Difficulties by Group at Measurement Times (Sleep Duration)
Time frame: pretest (Measurements taken during the initial consultation)
In this measurement, the sleep duration was recorded as subjective data by the researcher. (Calculated based on the intended bedtime and wake-up time)
2 secondary outcomes
Visual Analogue Scale
Time frame: posttest (three weeks after the pre-test)
Comparison of Sleep Duration and Sleep Onset Difficulties by Group at Measurement Times (Sleep Duration)
Time frame: posttest (three weeks after the pre-test)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Berna Bayır principal investigator
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic touch in people with Therapeutic Adherence and Nurse-Patient Relations, run by KTO Karatay 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 3 inclusion and 2 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 4 Sep 2026. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analogue Scale (time frame: pretest (Measurements taken during the initial consultation)). 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 4 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.