Therapeutic Touch on Pain, Delirium, Sleep, and Physiological Parameters

NCT07404904 | Completed

• 1 other identifier: Aksaray Hospital
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study was conducted to determine the effects of therapeutic touch applied to intensive care patients on pain, delirium, sleep and physiological parameters.

Conditions

Sleep Disturbance; Delirium

Keywords

Therapeutic Touch; Pain; Sleep Quality; Delirium Level

Outcome Measures

Primary Outcomes (8)

• VAS (Visual Analog Scale)

  Pain intensity measured using a 0-10 Visual Analog Scale (0 = no pain, 10 = worst pain).

  At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

• RASS (Richmond Agitation and Sedation Scale)

  Sedation/agitation level scored from +4 (combative) to -5 (unarousable).

  At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

• RCSQ (Richards-Campbell Sleep Questionnaire)

  Sleep quality assessed with RCSQ, range 0-100.

  At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

• Blood pressure

  Systolic and diastolic blood pressure measured using standard bedside monitoring in the intensive care unit.

  At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

• Heart rate

  Heart rate measured using continuous bedside cardiac monitoring in the intensive care unit.

  At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

• Respiratory rate

  Respiratory rate measured and recorded as breaths per minute using bedside monitoring.

  At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

• Body temperature

  Body temperature measured using a standard clinical thermometer in the intensive care unit.

  At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

• Oxygen saturation

  Peripheral oxygen saturation measured by pulse oximetry.

  At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).

Secondary Outcomes (8)

• VAS (Visual Analog Scale)

  At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).

• RASS (Richmond Agitation and Sedation Scale)

  At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).

• RCSQ (Richards-Campbell Sleep Questionnaire)

  At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).

• Blood pressure

  At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).

• Heart rate

  At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).

Study Arms (2)

Randomized control

EXPERIMENTAL

Experimental (therapeutic touch)

Other: therapeutic touch

Control

NO INTERVENTION

Control (routine care)

Interventions

therapeutic touch OTHER

therapeutic touch

Also known as: routine maintenance

Randomized control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who volunteer to participate in the study,
• Patients aged 18 and over who receive post-surgical treatment at the Surgical Intensive Care Unit of Aksaray Education and Research Hospital,
• Patients who do not have communication problems (hearing, speaking, understanding, etc.),
• Patients who have received treatment in the surgical intensive care unit for at least 72 hours,
• Patients with RASS: between -3 and +4 and Glasgow coma scale: 10 and above,
• Patients who use only non-steroidal drugs as analgesics,
• Patients whose medical diagnosis is not dementia,
• Patients who do not have a mental state disorder/psychological disease and do not use sleeping pills.

You may not qualify if:

• Patients who developed complications in the ICU after surgery,
• Patients who received treatment in the surgical intensive care unit for less than 72 hours.

Sponsors & Collaborators

• Sibel Oksuz: lead
• Aksaray University: collaborator

Study Sites (1)

Aksaray Universitesi

Aksaray, 68100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parasomnias; Delirium; Pain; Sleep Initiation and Maintenance Disorders

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sibel Öksüz

  Aksaray University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not know which group they are in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: February 12, 2026
• Study Start: October 10, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 28, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

TU (1)