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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07404904
Enrollment
80
Registered
2026-02-12
Start date
2024-10-10
Completion date
2025-02-28
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Sleep Disturbance

Keywords

Therapeutic Touch, Pain, Sleep Quality, Delirium Level

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.

Detailed description

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.

Interventions

OTHERtherapeutic touch

therapeutic touch

Sponsors

Sibel Oksuz
Lead SponsorOTHER
Aksaray University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

Participants do not know which group they are in the study.

Intervention model description

Randomized control

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood pressureAt 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.
VAS (Visual Analog Scale)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).
RASS (Richmond Agitation and Sedation Scale)At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).Sedation/agitation level scored from +4 (combative) to -5 (unarousable).
RCSQ (Richards-Campbell Sleep Questionnaire)At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).Sleep quality assessed with RCSQ, range 0-100.
Heart rateAt 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.
Respiratory rateAt 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).Respiratory rate measured and recorded as breaths per minute using bedside monitoring.
Body temperatureAt 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.
Oxygen saturationAt 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).Peripheral oxygen saturation measured by pulse oximetry.

Secondary

MeasureTime frameDescription
VAS (Visual Analog Scale)At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).Pain intensity measured using a 0-10 Visual Analog Scale.
RASS (Richmond Agitation and Sedation Scale)At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).Sedation/agitation scored from +4 to -5.
RCSQ (Richards-Campbell Sleep Questionnaire)At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).Sleep quality assessed with RCSQ, range 0-100.
Blood pressureAt 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.
Heart rateAt 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.
Respiratory rateAt 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).Respiratory rate measured and recorded as breaths per minute using bedside monitoring.
Body temperatureAt 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.
Oxygen saturationAt 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).Peripheral oxygen saturation measured by pulse oximetry.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORSibel Öksüz

Aksaray University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026