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

NCT07061340 | Not Yet Recruiting

• 1 other identifier: 2025/08-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Therapeutic Touch

Keywords

Therapeutic Touch; İntensive Care; Pain; Agitation; Cortisol; Nursing

Outcome Measures

Primary Outcomes (3)

• Richmond Agitation-Sedation Scale

  The Richmond Agitation-Sedation Scale is a highly reliable and valid assessment tool developed to assess the agitation and sedation levels of intensive care patients. The scale is scored between -5 (deep sedation) and +4 (severe agitation) according to the patients' reactions to environmental stimuli. Individuals with a scale score of "0" are considered alert and calm, while negative scores indicate the depth of sedation and positive scores indicate the severity of agitation. It is widely preferred in clinical practice because it can be applied in a short time and can be used in an integrated manner with nursing care

  After application,about 1 hour later

• Visual Analog Scale

  The scale is frequently used in the assessment phase of pain intensity. Patients are asked to indicate the intensity of pain during activity or rest on a 10 cm long vertical or horizontal line. The line has a value of 0 at the beginning and 10 at the end. 10 means unbearable pain, and 0 means no pain at all. While the patient marks the pain they feel on this line, each point they mark is measured in cm.

  After application,about 1 hour later

• Blood Cortisol Level

  To be taken from patient records

  After application,about 1 hour later

Study Arms (2)

Therapeutic Touch

EXPERIMENTAL

Therapeutic weaving will be done

Behavioral: Therapeutic Touch

Control

NO INTERVENTION

Therapeutic weaving will not be done

Interventions

Therapeutic Touch BEHAVIORAL

no Therapeutic Touch

Also known as: Control

Therapeutic Touch

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat university

Elâzığ, Center, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Psychomotor Agitation

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Gülcan Bahçecioğlu Turan

CONTACT

05065576086; glcnbah@hotmail.com

Merve KAYA

CONTACT

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: July 2, 2025
• First Posted: July 11, 2025
• Study Start: December 31, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)