- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404904
Therapeutic Touch on Pain, Delirium, Sleep, and Physiological Parameters
February 9, 2026 updated by: Sibel Oksuz
Evaluation of the Effects of Therapeutic Touch on Pain, Delirium, Sleep, and Physiological Parameters in Intensive Care Patients
The study was conducted to determine the effects of therapeutic touch applied to intensive care patients on pain, delirium, sleep and physiological parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aksaray, Turkey (Türkiye), 68100
- Aksaray Universitesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Randomized control
Experimental (therapeutic touch)
|
therapeutic touch
Other Names:
|
|
No Intervention: Control
Control (routine care)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
|
|
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).
|
At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
|
|
Oxygen saturation
Time Frame: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
|
Peripheral oxygen saturation measured by pulse oximetry.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
|
|
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.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
|
|
Oxygen saturation
Time Frame: At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
|
Peripheral oxygen saturation measured by pulse oximetry.
|
At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Sibel Öksüz, Aksaray University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2024
Primary Completion (Actual)
December 1, 2024
Study Completion (Actual)
February 28, 2025
Study Registration Dates
First Submitted
June 18, 2025
First Submitted That Met QC Criteria
February 9, 2026
First Posted (Actual)
February 12, 2026
Study Record Updates
Last Update Posted (Actual)
February 12, 2026
Last Update Submitted That Met QC Criteria
February 9, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Delirium
- Parasomnias
- Sleep Initiation and Maintenance Disorders
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Therapeutic Touch
Other Study ID Numbers
- Aksaray Hospital
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Delirium
-
Alexandria UniversityCompletedClozapine Poisoning | Hypoactive Delirium | Tricyclic Antidepressant Poisoning | Anticholinergic Delirium | Antipsychotic Toxicity | CNS Depression | Procyclidine Induced DeliriumEgypt
-
Efficacy Care R&D LtdHadassah Medical OrganizationUnknownDelirium | Delirium, Cause Unknown | Delirium of Mixed Origin | Delirium Confusional State | Delirium Drug-InducedIsrael
-
Duke UniversityNot yet recruitingDelirium Confusional State | Hyperactive Delirium | Delirium in the Intensive Care Unit | Agitated DeliriumUnited States
-
Sengkang General HospitalRecruitingDelirium and Post-operative Cognitive Dysfunction (POCD) | Delirium, Postoperative | Delirium - PostoperativeSingapore
-
Imperial College Healthcare NHS TrustRecruitingCardiac Surgery | Intensive Care Unit Delirium | Post Operative DeliriumUnited Kingdom
-
Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicCompletedDelirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional StateNorway
-
Universitat de LleidaHospital d'IgualadaNot yet recruitingDelirium in Old Age | Delirium Treatment | Delirium Confusional StateSpain
-
Universidad de SantanderUnknownDelirium of Mixed Origin | Hypoactive Delirium | Hyperactive DeliriumColombia
-
Wonkwang University HospitalCompleted
-
Second Affiliated Hospital of Wenzhou Medical UniversityAffiliated Wenling Hospital of Wenzhou Medical UniversityRecruitingInjection | Delirium in Old Age | Post Operative Delirium | Non-cardiac SurgeryChina
Clinical Trials on therapeutic touch
-
Cukurova UniversityCompletedFatigue | Sleep | Menopause | Therapeutic TouchTurkey
-
Ayşe BelpınarCompletedPreterm Infants | Pain Management | Nasal Continuous Positive Airway PressureTurkey
-
Mardin Artuklu UniversityCompletedFatigue | Stress | SleepinessTurkey
-
Dokuz Eylul UniversityCompletedPain, Acute | NewbornTurkey
-
Burdur Mehmet Akif Ersoy UniversityCompletedPain, Acute | Newborn | CryingTurkey
-
Zehra BayramCompleted
-
Karamanoğlu Mehmetbey UniversityCompletedInfantile Colic | Therapeutic TouchTurkey
-
Cukurova UniversityCompletedComfort | Therapeutic Touch | Midwifery | Postpartum PeriodTurkey
-
Dilek GÜRÇAYIRCompletedIntraoperative ComplicationsTurkey
-
Cumhuriyet UniversityCompletedVaginal Delivery | First PregnancyTurkey (Türkiye)