The Effect of Therapeutic Touch on Agitation, Pain, and Cortisol Levels in Intensive Care Patients

Official title

The Effect of Therapeutic Touch on Agitation, Pain, and Cortisol Levels in Intensive Care Patients: A Randomized Controlled Study

Overview

Intensive care units (ICU) are special clinical areas where advanced monitoring and treatment of patients with life-threatening organ failure or those at risk of developing organ failure are carried out, with high technological equipment and a multidisciplinary approach is adopted. Agitation, pain, anxiety and hormonal imbalances are frequently observed due to hospitalization in ICU. In this stressful environment, patients often experience pain and agitation. Both situations trigger a physiological stress response in the patient and increase cortisol secretion. This increase in cortisol levels can suppress the immune system, delay wound healing and negatively affect the patient's general prognosis. Today, in addition to modern medicine, complementary/alternative therapies are increasingly used. One of these alternative therapies is therapeutic touch application. Therapeutic touch is based on the therapeutic effect of the act of touching. Therapeutic touch, alternatively known as healing touch, is a complementary/alternative treatment method applied by touching energy points on the body. Therefore, this study was planned to examine the effects of therapeutic touch applied to patients in intensive care on pain, agitation and cortisol levels. This study, planned as a randomized experimental study with a pre-test-post-test intervention control group, will consist of patients in the Intensive Care Unit of Fırat University Hospital. The sample will consist of 60 intensive care patients, 30 in the intervention group and 30 in the control group, who meet the research criteria on the specified dates and accept the research. The patients in the intervention and control groups will first be informed about the application before starting the application and their verbal and written consents will be obtained. Then, the intervention group will be given the Patient Identification Form, Richmond Agitation-Sedation Scale (RASS), Visual Analog Scale (VAS), cortisol levels from laboratory data will be recorded and therapeutic touch will be applied and after the application, the RASS and VAS scales will be filled again and the blood cortisol levels will be checked. This process will be done before and after each application and a total of 8 measurements will be taken. The application will take approximately 15-30 minutes every four days for the patients in the intervention group. During this period, no application will be made to the patients in the control group and RASS, VAS scales will be filled every four days and blood cortisol levels will be checked. Thus, a total of 8 measurements will be obtained. In the analysis of the data; frequency and percentage analyses, chi-square analysis, standard deviation, t-test in dependent groups, t-test analysis in independent groups will be performed.

Interventions

• Behavioral Therapeutic Touch
  no Therapeutic Touch

Primary outcome measures

• Richmond Agitation-Sedation Scale [Time frame: After application,about 1 hour later]
• Visual Analog Scale [Time frame: After application,about 1 hour later]
• Blood Cortisol Level [Time frame: After application,about 1 hour later]

Eligibility criteria

Inclusion criteria

• Adults aged 18 years and above.
• Patients who can communicate verbally.
• Patients who have been monitored in the intensive care unit for at least 4 days.
• Patients who are able to give informed consent.
• Patients who are hemodynamically stable.
• Richmond Agitation-Sedation Scale 1 and above.
• Visual Analog Scale 1 and above.

Exclusion criteria

• Patients under deep sedation.
• Patients on mechanical ventilation.
• Patients with psychiatric problems.
• Patients with skin diseases or open wounds, infections, burns that would prevent therapeutic touch.
• Patients using sedative/analgesic drugs (excessive sedation or delirium).
• Patients using corticosteroids or drugs that affect adrenal hormone levels (because these drugs can affect cortisol measurements).
• Patients who have sudden life-threatening clinical changes during intensive care (e.g. sudden cardiac arrest, 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: NCT07061340 · 2025/08-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗