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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Randomized control
Experimental (therapeutic touch)
Other: therapeutic touch
therapeutic touch
Other Names:
  • routine maintenance
No Intervention: Control
Control (routine care)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sibel Oksuz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aksaray University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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