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

NCT ID: NCT07061340

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Therapeutic Touch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Therapeutic Touch

Therapeutic weaving will be done

Group Type EXPERIMENTAL

Therapeutic Touch

Intervention Type BEHAVIORAL

no Therapeutic Touch

Control

Therapeutic weaving will not be done

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Therapeutic Touch

no Therapeutic Touch

Intervention Type BEHAVIORAL

Other Intervention Names

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Control

Eligibility Criteria

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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

1. Patients under deep sedation.
2. Patients on mechanical ventilation.
3. Patients with psychiatric problems.
4. Patients with skin diseases or open wounds, infections, burns that would prevent therapeutic touch.
5. Patients using sedative/analgesic drugs (excessive sedation or delirium).
6. Patients using corticosteroids or drugs that affect adrenal hormone levels (because these drugs can affect cortisol measurements).
7. Patients who have sudden life-threatening clinical changes during intensive care (e.g. sudden cardiac arrest, shock).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Firat University

OTHER

Sponsor Role lead

Responsible Party

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Gülcan Bahçecioğlu Turan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fırat university

Elâzığ, Center, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Gülcan Bahçecioğlu Turan

Role: CONTACT

05065576086

Merve KAYA

Role: CONTACT

Other Identifiers

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2025/08-03

Identifier Type: -

Identifier Source: org_study_id

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