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Not yet recruiting NCT07520773

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

No phase Interventional Intensive Care Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Therapeutic Touch.
Who it may be relevant to
Registry conditions: Intensive Care Patients. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Therapeutic Touch
    Therapeutic Touch

Primary outcome measures

  • Visual Analog Scale-Comfort [Time frame: 30 minutes post-intervention)]
  • Richard Campbell Sleep Questionnaire [Time frame: One day after the procedure]
  • The Therapeutic Touch Pre/Post Physiological Parameters Form [Time frame: 30 minutes post-intervention]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Fırat university — Elâzığ

Identifiers

NCT: NCT07520773 · 2026/02-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗