Therapeutic TouchNCT07061340
The Effect of Therapeutic Touch on Agitation, Pain, and Cortisol Levels in Intensive Care Patients
A study testing Therapeutic Touch in people with Therapeutic Touch, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Intensive care units (ICU) are special clinical areas where advanced monitoring and treatment of patients with life-threatening organ failure or those at risk of developing organ failure are carried out, with high technological equipment and a multidisciplinary approach is adopted. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Touch
- What is being tested?
- Therapeutic Touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and above.
- Patients who can communicate verbally.
- Patients who have been monitored in the intensive care unit for at least 4 days.
- Patients who are able to give informed consent.
- Patients who are hemodynamically stable.
- Richmond Agitation-Sedation Scale 1 and above.
- Visual Analog Scale 1 and above.
Who cannot join
- Patients under deep sedation.
- Patients on mechanical ventilation.
- Patients with psychiatric problems.
- Patients with skin diseases or open wounds, infections, burns that would prevent therapeutic touch.
- Patients using sedative/analgesic drugs (excessive sedation or delirium).
- Patients using corticosteroids or drugs that affect adrenal hormone levels (because these drugs can affect cortisol measurements).
- Patients who have sudden life-threatening clinical changes during intensive care (e.g. sudden cardiac arrest, shock).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Merve KAYA contact
About this study
Official title: The Effect of Therapeutic Touch on Agitation, Pain, and Cortisol Levels in Intensive Care Patients: A Randomized Controlled Study
Intensive care units (ICU) are special clinical areas where advanced monitoring and treatment of patients with life-threatening organ failure or those at risk of developing organ failure are carried out, with high technological equipment and a multidisciplinary approach is adopted. Agitation, pain, anxiety and hormonal imbalances are frequently observed due to hospitalization in ICU. In this stressful environment, patients often experience pain and agitation. Both situations trigger a physiological stress response in the patient and increase cortisol secretion. This increase in cortisol levels can suppress the immune system, delay wound healing and negatively affect the patient's general prognosis. Today, in addition to modern medicine, complementary/alternative therapies are increasingly used. One of these alternative therapies is therapeutic touch application. Therapeutic touch is based on the therapeutic effect of the act of touching. Therapeutic touch, alternatively known as healing touch, is a complementary/alternative treatment method applied by touching energy points on the body. Therefore, this study was planned to examine the effects of therapeutic touch applied to patients in intensive care on pain, agitation and cortisol levels. This study, planned as a randomized experimental study with a pre-test-post-test intervention control group, will consist of patients in the Intensive Care Unit of Fırat University Hospital. The sample will consist of 60 intensive care patients, 30 in the intervention group and 30 in the control group, who meet the research criteria on the specified dates and accept the research. The patients in the intervention and control groups will first be informed about the application before starting the application and their verbal and written consents will be obtained. Then, the intervention group will be given the Patient Identification Form, Richmond Agitation-Sedation Scale (RASS), Visual Analog Scale (VAS), cortisol levels from laboratory data will be recorded and therapeutic touch will be applied and after the application, the RASS and VAS scales will be filled again and the blood cortisol levels will be checked. This process will be done before and after each application and a total of 8 measurements will be taken. The application will take approximately 15-30 minutes every four days for the patients in the intervention group. During this period, no application will be made to the patients in the control group and RASS, VAS scales will be filled every four days and blood cortisol levels will be checked. Thus, a total of 8 measurements will be obtained. In the analysis of the data; frequency and percentage analyses, chi-square analysis, standard deviation, t-test in dependent groups, t-test analysis in independent groups will be performed.
- Conditions
- Therapeutic Touch
- Being tested
- Therapeutic Touch
- Keywords
- Therapeutic Touch, İntensive Care, Pain, Agitation, Cortisol, Nursing
- Medical subject headings
- Pain, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchBehavioural
Also called Control
no Therapeutic Touch
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Touch | Experimental | Therapeutic weaving will be done Receives: Behavioral: Therapeutic Touch |
| Control | No intervention | Therapeutic weaving will not be done |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richmond Agitation-Sedation Scale
The Richmond Agitation-Sedation Scale is a highly reliable and valid assessment tool developed to assess the agitation and sedation levels of intensive care patients. The scale is scored between -5 (deep sedation) and +4 (severe agitation) according to the patients' reactions to environmental stimuli. Individuals with a scale score of "0" are considered alert and calm, while negative scores indicate the depth of sedation and positive scores indicate the severity of agitation. It is widely preferred in clinical practice because it can be applied in a short time and can be used in an integrated manner with nursing care
Measured: After application,about 1 hour later
Visual Analog Scale
The scale is frequently used in the assessment phase of pain intensity. Patients are asked to indicate the intensity of pain during activity or rest on a 10 cm long vertical or horizontal line. The line has a value of 0 at the beginning and 10 at the end. 10 means unbearable pain, and 0 means no pain at all. While the patient marks the pain they feel on this line, each point they mark is measured in cm.
Measured: After application,about 1 hour later
Blood Cortisol Level
To be taken from patient records
Measured: After application,about 1 hour later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start31 Dec 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic TouchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061340
- Sponsor's protocol ID
- 2025/08-03
- Status last verified
- Nov 2025
- First submitted
- 2 Jul 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Touch on Agitation, Pain, and Cortisol Levels in Intensive Care Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07061340
- Acronym / sponsor ID
- 2025/08-03
- Conditions
- Therapeutic Touch
- Keywords
- Therapeutic Touch, İntensive Care, Pain, Agitation, Cortisol, Nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intensive care units (ICU) are special clinical areas where advanced monitoring and treatment of patients with life-threatening organ failure or those at risk of developing organ failure are carried out, with high technological equipment and a multidisciplinary approach is adopted. Agitation, pain, anxiety and hormonal imbalances are frequently observed due to hospitalization in ICU. In this stressful environment, patients often experience pain and agitation. Both situations trigger a physiological stress response in the patient and increase cortisol secretion. This increase in cortisol levels can suppress the immune system, delay wound healing and negatively affect the patient's general prognosis. Today, in addition to modern medicine, complementary/alternative therapies are increasingly used. One of these alternative therapies is therapeutic touch application. Therapeutic touch is based on the therapeutic effect of the act of touching. Therapeutic touch, alternatively known as healing touch, is a complementary/alternative treatment method applied by touching energy points on the body. Therefore, this study was planned to examine the effects of therapeutic touch applied to patients in intensive care on pain, agitation and cortisol levels. This study, planned as a randomized experimental study with a pre-test-post-test intervention control group, will consist of patients in the Intensive Care Unit of Fırat University Hospital. The sample will consist of 60 intensive care patients, 30 in the intervention group and 30 in the control group, who meet the research criteria on the specified dates and accept the research. The patients in the intervention and control groups will first be informed about the application before starting the application and their verbal and written consents will be obtained. Then, the intervention group will be given the Patient Identification Form, Richmond Agitation-Sedation Scale (RASS), Visual Analog Scale (VAS), cortisol levels from laboratory data will be recorded and therapeutic touch will be applied and after the application, the RASS and VAS scales will be filled again and the blood cortisol levels will be checked. This process will be done before and after each application and a total of 8 measurements will be taken. The application will take approximately 15-30 minutes every four days for the patients in the intervention group. During this period, no application will be made to the patients in the control group and RASS, VAS scales will be filled every four days and blood cortisol levels will be checked. Thus, a total of 8 measurements will be obtained. In the analysis of the data; frequency and percentage analyses, chi-square analysis, standard deviation, t-test in dependent groups, t-test analysis in independent groups will be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Touch | Experimental | Behavioral: Therapeutic TouchTherapeutic weaving will be done |
| Control | No intervention | –Therapeutic weaving will not be done |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years and above.
- Patients who can communicate verbally.
- Patients who have been monitored in the intensive care unit for at least 4 days.
- Patients who are able to give informed consent.
- Patients who are hemodynamically stable.
Key exclusion criteria (7 listed)
- Patients under deep sedation.
- Patients on mechanical ventilation.
- Patients with psychiatric problems.
- Patients with skin diseases or open wounds, infections, burns that would prevent therapeutic touch.
- Patients using sedative/analgesic drugs (excessive sedation or delirium).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic TouchAlso: Controlno Therapeutic Touch | Behavioural | Therapeutic Touch |
Primary outcome
Richmond Agitation-Sedation Scale
Time frame: After application,about 1 hour later
The Richmond Agitation-Sedation Scale is a highly reliable and valid assessment tool developed to assess the agitation and sedation levels of intensive care patients. The scale is scored between -5 (deep sedation) and +4 (severe agitation) according to the patients' reactions to environmental stimuli. Individuals with a scale score of "0" are considered alert and calm, while negative scores indicate the depth of sedation and positive scores indicate the severity of agitation. It is widely preferred in clinical practice because it can be applied in a short time and can be used in an integrated manner with nursing care
Visual Analog Scale
Time frame: After application,about 1 hour later
The scale is frequently used in the assessment phase of pain intensity. Patients are asked to indicate the intensity of pain during activity or rest on a 10 cm long vertical or horizontal line. The line has a value of 0 at the beginning and 10 at the end. 10 means unbearable pain, and 0 means no pain at all. While the patient marks the pain they feel on this line, each point they mark is measured in cm.
Blood Cortisol Level
Time frame: After application,about 1 hour later
To be taken from patient records
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merve KAYA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Touch in people with Therapeutic Touch, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gülcan Bahçecioğlu Turan (05065576086, glcnbah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richmond Agitation-Sedation Scale (time frame: After application,about 1 hour later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.