Therapeutic Touch on Sleep, Comfort, and Physiological Parameters in Intensive Care Patients

April 9, 2026 updated by: Gülcan Bahçecioğlu Turan, Firat University

The Effect of Therapeutic Touch on Sleep, Comfort, and Physiological Parameters in Intensive Care Patients: A Randomized, Placebo-Controlled Study

Intensive care units are critical clinical areas where patients in life-threatening conditions receive care under advanced technology and continuous monitoring. In this environment, patients' sleep patterns and comfort levels are frequently disrupted, which can negatively affect physiological stability and the recovery process. The aim of this thesis proposal is to examine the effects of therapeutic touch applied to intensive care patients on sleep quality, comfort level, and physiological parameters. The research is planned as a randomized experimental study with intervention, placebo, and control groups. The study will be conducted in the Coronary Intensive Care Unit of Fırat University Hospital between April 2026 and January 2027, and a total of 90 patients meeting the research criteria will be randomized into intervention (n=30), placebo (n=30), and control (n=30) groups. The research materials consist of the Patient Identification Form, VAS-Comfort Scale, Sleep Scale, and measurements of physiological parameters (heart rate, blood pressure, body temperature, respiratory rate, oxygen saturation). The intervention group will receive therapeutic touch, the placebo group will receive superficial contact, and the control group will receive routine care. The applications will be performed daily at 8:00 PM, and comfort scale and physiological parameters will be measured before and 30 minutes after the application. Sleep quality, as an outcome variable occurring throughout the night, will be assessed the following day using the Sleep Scale. This process will be repeated for 3 days. The obtained data will be analyzed using appropriate statistical methods. In addition to descriptive statistics, One-Way Analysis of Variance (ANOVA) will be used for intergroup comparisons, and Repeated Measures ANOVA will be used to evaluate changes over time. In case of a significant difference, Bonferroni corrected post-hoc tests will be applied. If parametric assumptions are not met, appropriate non-parametric tests will be preferred. The significance level will be accepted as p<0.05. This study aims to contribute to the development of evidence-based practices in nursing care by revealing the effects of therapeutic touch on sleep quality, comfort level, and physiological parameters of intensive care patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Center
      • Elâzığ, Center, Turkey (Türkiye), 25240
        • Fırat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adults aged 18 and over.
  2. Patients who can communicate verbally.
  3. Patients monitored in the intensive care unit for at least 3 days.
  4. Patients who can give informed consent.
  5. Hemodynamically stable patients.

Exclusion Criteria:

  1. Patients under deep sedation.
  2. Patients on mechanical ventilation.
  3. Patients with psychiatric problems.
  4. Patients with skin diseases or conditions such as open wounds, infections, or burns that would prevent therapeutic touch.
  5. Patients with excessive sedation or delirium due to sedative/analgesic use.
  6. Patients experiencing sudden, life-threatening clinical changes during intensive care (e.g., sudden cardiac arrest or shock).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: Therapeutic Touch
Therapeutic Touch Group
Behavioral: Therapeutic Touch
Therapeutic Touch
Sham Comparator: Sham group
The sham group will receive a simulated therapeutic touch procedure. The practitioner will mimic the hand movements and duration of the intervention without intentional energy transfer or therapeutic focus. The procedure will be performed at the same time, in the same environment, and for the same duration (approximately 15 minutes) as the intervention group.
Behavioral: Therapeutic Touch
Therapeutic Touch

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale-Comfort
Time Frame: 30 minutes post-intervention)
Widely used to measure the subjective comfort level of intensive care patients, the VAS Comfort is a self-report scale rated on a scale of 0-10 points. A score of 0 indicates that the individual is "not comfortable at all," and a score of 10 indicates that they are "excellently comfortable" (Huskisson, 1974). The scale allows for a quick and easy assessment of patients' comfort levels based on their own perceptions. Validity and reliability studies in Turkish are also available; for example, in the study by Ateş et al. (2018), it was determined that the Turkish form of the VAS Comfort is valid and reliable in clinical application
30 minutes post-intervention)
Richard Campbell Sleep Questionnaire
Time Frame: One day after the procedure
Scale is a five-item self-report scale developed to assess the perceived sleep quality of intensive care patients (Richards, O'Sullivan & Phillips, 2000). The scale covers the dimensions of sleep depth, time to fall asleep, frequency of awakenings, time spent awake, and overall sleep quality. Each item is scored on a visual analog scale (VAS) of 0-100 mm; 0 indicates "worst sleep", and 100 indicates "best sleep". The total score is calculated by taking the arithmetic mean of the five items, and higher scores indicate better sleep quality. The RCSQ is widely preferred in clinical studies because it can be applied quickly and safely in conscious and communicative intensive care patients. The Turkish adaptation and validity-reliability study of the scale was conducted by Karaman Özlü & Özer (2015); it was reported that the Turkish form is reliable and valid, with a Cronbach's alpha coefficient of 0.91.
One day after the procedure
The Therapeutic Touch Pre/Post Physiological Parameters Form
Time Frame: 30 minutes post-intervention
This is a data collection tool created by the researcher to evaluate the physiological effects of therapeutic touch application. In the form, physiological parameters such as heart rate, blood pressure, body temperature, respiratory rate, and oxygen saturation are recorded before and after the application, and the effect of therapeutic touch is evaluated by comparing the obtained values.
30 minutes post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/02-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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