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Completed

NCT Number: NCT07404904

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

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

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Key information

Conditions

Sleep Disturbance Confusion Delirium Dyssomnias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aksaray Universitesi

Aksaray, 68100, Turkey (Türkiye)

About this study

This study aims to evaluate the effects of therapeutic touch on pain, delirium, sleep, and physiological parameters in surgical intensive care patients. Patients will be assessed at 24, 48, and 72 hours. The intervention and control groups will be randomized. The intervention group will receive routine care and therapeutic touch, while the control group will receive only routine care. Parameters will be assessed before and after each measurement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Therapeutic Touch

Other

therapeutic touch

Other names: routine maintenance

Primary outcomes

  1. VAS (Visual Analog Scale)

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

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

  2. RASS (Richmond Agitation and Sedation Scale)

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

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

  3. RCSQ (Richards-Campbell Sleep Questionnaire)

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

    Sleep quality assessed with RCSQ, range 0-100.

  4. Blood pressure

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

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

  5. Heart rate

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

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

  6. Respiratory rate

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

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

  7. Body temperature

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

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

  8. Oxygen saturation

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

    Peripheral oxygen saturation measured by pulse oximetry.

Secondary outcomes

  1. VAS (Visual Analog Scale)

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

    Pain intensity measured using a 0-10 Visual Analog Scale.

  2. RASS (Richmond Agitation and Sedation Scale)

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

    Sedation/agitation scored from +4 to -5.

  3. RCSQ (Richards-Campbell Sleep Questionnaire)

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

    Sleep quality assessed with RCSQ, range 0-100.

  4. Blood pressure

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

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

  5. Heart rate

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

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

  6. Respiratory rate

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

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

  7. Body temperature

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

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

  8. Oxygen saturation

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

    Peripheral oxygen saturation measured by pulse oximetry.

Sponsors and collaborators

Lead sponsor

Sibel Oksuz

Other

Collaborators

  • Aksaray University

Registry information

Official study title

Evaluation of the Effects of Therapeutic Touch on Pain, Delirium, Sleep, and Physiological Parameters in Intensive Care Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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