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

NCT07520773 | Not Yet Recruiting

• 1 other identifier: 2026/02-03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intensive Care Patients

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale-Comfort

  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

  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

  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

Study Arms (3)

Therapeutic Touch

EXPERIMENTAL

Therapeutic Touch Group

Behavioral: Therapeutic Touch

Sham group

SHAM COMPARATOR

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

Control group

NO INTERVENTION

Interventions

Therapeutic Touch BEHAVIORAL

Therapeutic Touch

Sham group; Therapeutic Touch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat university

Elâzığ, Center, 25240, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Therapeutic Touch

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)