Sleep DisturbanceNCT07404904
Therapeutic Touch on Pain, Delirium, Sleep, and Physiological Parameters
A study testing therapeutic touch in people with Sleep Disturbance and Delirium, run by Sibel Oksuz at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to determine the effects of therapeutic touch applied to intensive care patients on pain, delirium, sleep and physiological parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance, Delirium
- What is being tested?
- therapeutic touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who developed complications in the ICU after surgery,
- Patients who received treatment in the surgical intensive care unit for less than 72 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Disturbance, Delirium
- Being tested
- therapeutic touch
- Keywords
- Therapeutic Touch, Pain, Sleep Quality, Delirium Level
- Medical subject headings
- Parasomnias, Delirium, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic touchOther
Also called routine maintenance
therapeutic touch
| Study group | Role | What they receive |
|---|---|---|
| Randomized control | Experimental | Experimental (therapeutic touch) Receives: Other: therapeutic touch |
| Control | No intervention | Control (routine care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (Visual Analog Scale)
Pain intensity measured using a 0-10 Visual Analog Scale (0 = no pain, 10 = worst pain).
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
RASS (Richmond Agitation and Sedation Scale)
Sedation/agitation level scored from +4 (combative) to -5 (unarousable).
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
RCSQ (Richards-Campbell Sleep Questionnaire)
Sleep quality assessed with RCSQ, range 0-100.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
Blood pressure
Systolic and diastolic blood pressure measured using standard bedside monitoring in the intensive care unit.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
Heart rate
Heart rate measured using continuous bedside cardiac monitoring in the intensive care unit.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
Respiratory rate
Respiratory rate measured and recorded as breaths per minute using bedside monitoring.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
Body temperature
Body temperature measured using a standard clinical thermometer in the intensive care unit.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
Oxygen saturation
Peripheral oxygen saturation measured by pulse oximetry.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
Secondary outcomes (8)
VAS (Visual Analog Scale)
Pain intensity measured using a 0-10 Visual Analog Scale.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
RASS (Richmond Agitation and Sedation Scale)
Sedation/agitation scored from +4 to -5.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
RCSQ (Richards-Campbell Sleep Questionnaire)
Sleep quality assessed with RCSQ, range 0-100.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
Blood pressure
Systolic and diastolic blood pressure measured using standard bedside monitoring in the intensive care unit.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
Heart rate
Heart rate measured using continuous bedside cardiac monitoring in the intensive care unit.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
Respiratory rate
Respiratory rate measured and recorded as breaths per minute using bedside monitoring.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
Body temperature
Body temperature measured using a standard clinical thermometer in the intensive care unit.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
Oxygen saturation
Peripheral oxygen saturation measured by pulse oximetry.
Measured: At 24 hours, 48 hours, and 72 hours after ICU admission (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start10 Oct 2024
- Primary completion1 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies 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
- Model description
- Randomized control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel Oksuz
- Sponsor type
- University, hospital or other
- Collaborators
- Aksaray University
- Responsible party
- Sponsor-investigator, Sibel Oksuz, Aksaray University
- Investigators
- Sibel Öksüz, Study director, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404904
- Sponsor's protocol ID
- Aksaray Hospital
- Status last verified
- Feb 2026
- First submitted
- 18 Jun 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Therapeutic Touch on Pain, Delirium, Sleep, and Physiological Parameters in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT07404904
- Acronym / sponsor ID
- Aksaray Hospital
- Conditions
- Sleep Disturbance, Delirium
- Keywords
- Therapeutic Touch, Pain, Sleep Quality, Delirium Level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sibel OksuzUniversity, hospital or other
- Collaborators
- Aksaray University
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 Feb 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control
| Arm | Type | Receives |
|---|---|---|
| Randomized control | Experimental | Other: therapeutic touchExperimental (therapeutic touch) |
| Control | No intervention | –Control (routine care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (2 listed)
- Patients who developed complications in the ICU after surgery,
- Patients who received treatment in the surgical intensive care unit for less than 72 hours.
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: routine maintenancetherapeutic touch | Other | Randomized control |
Primary outcome
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).
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).
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.
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.
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.
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.
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.
Oxygen saturation
Time frame: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).
Peripheral oxygen saturation measured by pulse oximetry.
8 secondary outcomes
VAS (Visual Analog Scale)
Time frame: 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).
RCSQ (Richards-Campbell Sleep Questionnaire)
Time frame: 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).
Heart rate
Time frame: 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).
Body temperature
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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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. This study is not recruiting at the moment.
Sibel Öksüz study director
Aksaray University
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 Sleep Disturbance and Delirium, run by Sibel Oksuz 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 12 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visual Analog Scale) (time frame: At 24 hours, 48 hours, and 72 hours after ICU admission (pre-intervention).). The study lists 8 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 12 Feb 2026.