Physical RestraintsComplicationsNCT07070505
Hand Massage for Physical Restraint
A study testing Experimental in people with Physical Restraints and Hand Massage, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
In this study, nurses will apply hand massage to patients who are physically restrained. It will be examined whether massage has a positive effect on patients' skin color, blood circulation, skin temperature and pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Restraints, Hand Massage
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2025to 10 Oct 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both physical and chemical restraint must be applied, a written request for restraint must be given by the physician, both upper extremities must be restrained, and verbal permission must be obtained from the relatives.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Ekrem Tok Mental Health Hospital
Adana
Ali Taşdemir, 05065943061, drmustafakurt61@gmail.com
About this study
Official title: Effect of Hand Massage on Physical Restraint Complications
In this study, nurses will apply hand massage to patients who are physically restrained. It will be examined whether massage has a positive effect on patients' skin color, blood circulation, skin temperature and pain. Physical restraint will be applied to patients only in the presence of medical indications and with the decision of a physician.
Research question: Does hand massage applied to patients in physical restraint have an effect on preventing complications related to restraint?
Read the detailed description
There are 2 groups in the study: experimental and control. Patients in the control group will be subjected to the hospital's routine physical restraint practices and will not receive hand massage.
- Conditions
- Physical Restraints, Hand Massage
- Being tested
- Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
- Before applying hand massage, the individual/patient's hand or arm will be evaluated for thrombus, phlebitis, ecchymosis, hematoma, deterioration in skin integrity and change in skin color in order to determine whether there is a risk.
- Hand massage application is a massage performed with western technique that includes five basic classical massage manipulations including efflorescence, petrissage, friction, tapotment and vibration.
- Massage should be performed in a way that creates light pressure on the individual, then the applied pressure should be gradually increased.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients in this group will be subjected to routine monitoring, which is included in the hospital procedure, every 30 minutes. Routine monitoring includes ensuring physical well-being, taking pulse, feeding, giving water, and meeting toilet needs. Records are kept by the nurse regarding these practices. During monitoring every 30 minutes, the patient's peripheral capillary refill time, skin integrity, skin color, skin temperature, and pain will be evaluated and recorded on the Patient Information and Restriction Monitoring Form. |
| Experimental group | Experimental | * Before applying hand massage, the individual/patient's hand or arm will be evaluated for thrombus, phlebitis, ecchymosis, hematoma, deterioration in skin integrity and change in skin color in order to determine whether there is a risk.
* Hand massage application is a massage performed with western technique that includes five basic classical massage manipulations including efflorescence, petrissage, friction, tapotment and vibration.
* Massage should be performed in a way that creates light pressure on the individual, then the applied pressure should be gradually increased. Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
During the 30. 60th. 90. 120. minutes follow-up, the patient's peripheral capillary refill time, skin integrity, skin color, skin temperature and pain will be evaluated.
Peripheral capillary refill time
( 0-2 sec : + ) ( >2 sec : ++ ) Skin integrity + yes
- no
If yes, specify:
- abrasion
- irritation
- laceration Specify skin color
- Pale/white
- red
- bruised
- pink Skin temperature
Compared to unrestricted area
- warmer
- colder
- no difference Pain (0-10 points) Ask the patient about the restricted area 0: I have no pain 10: Unbearable pain 30th min 60th min 90th min 120th min
Measured: for 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start10 Jun 2025
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical RestraintsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in this group will be subjected to routine monitoring as per the hospital procedure every 30 minutes. In addition, one of the patient's wrists that is under restraint will be opened for 5 minutes every 30 minutes and a hand massage will be applied. The open wrist will be restricted again after the 5 minutes are completed. This application will be repeated every 30 minutes until the total restriction period requested by the physician is completed. During the monitoring performed every 30 minutes, the patient's peripheral capillary refill time, skin integrity, skin color, skin temperature and pain will be evaluated and recorded in the Patient Information and Restriction Monitoring Form.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ECE KURT, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070505
- Sponsor's protocol ID
- Adana City Hospital
- Acronym
- Complications
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2025
- Last updated
- 17 Jul 2025
- 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hand Massage on Physical Restraint Complications
- ClinicalTrials.gov ID
- NCT07070505
- Acronym / sponsor ID
- Complications / Adana City Hospital
- Conditions
- Physical Restraints, Hand Massage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 17 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.
In this study, nurses will apply hand massage to patients who are physically restrained. It will be examined whether massage has a positive effect on patients' skin color, blood circulation, skin temperature and pain. Physical restraint will be applied to patients only in the presence of medical indications and with the decision of a physician.
Research question: Does hand massage applied to patients in physical restraint have an effect on preventing complications related to restraint?
Detailed description
There are 2 groups in the study: experimental and control. Patients in the control group will be subjected to the hospital's routine physical restraint practices and will not receive hand massage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in this group will be subjected to routine monitoring as per the hospital procedure every 30 minutes. In addition, one of the patient's wrists that is under restraint will be opened for 5 minutes every 30 minutes and a hand massage will be applied. The open wrist will be restricted again after the 5 minutes are completed. This application will be repeated every 30 minutes until the total restriction period requested by the physician is completed. During the monitoring performed every 30 minutes, the patient's peripheral capillary refill time, skin integrity, skin color, skin temperature and pain will be evaluated and recorded in the Patient Information and Restriction Monitoring Form.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients in this group will be subjected to routine monitoring, which is included in the hospital procedure, every 30 minutes. Routine monitoring includes ensuring physical well-being, taking pulse, feeding, giving water, and meeting toilet needs. Records are kept by the nurse regarding these practices. During monitoring every 30 minutes, the patient's peripheral capillary refill time, skin integrity, skin color, skin temperature, and pain will be evaluated and recorded on the Patient Information and Restriction Monitoring Form. |
| Experimental group | Experimental | Other: Experimental* Before applying hand massage, the individual/patient's hand or arm will be evaluated for thrombus, phlebitis, ecchymosis, hematoma, deterioration in skin integrity and change in skin color in order to determine whether there is a risk. * Hand massage application is a massage performed with western technique that includes five basic classical massage manipulations including efflorescence, petrissage, friction, tapotment and vibration. * Massage should be performed in a way that creates light pressure on the individual, then the applied pressure should be gradually increased. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Both physical and chemical restraint must be applied, a written request for restraint must be given by the physician, both upper extremities must be restrained, and verbal permission must be obtained from the relatives.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Experimental* Before applying hand massage, the individual/patient's hand or arm will be evaluated for thrombus, phlebitis, ecchymosis, hematoma, deterioration in skin integrity and change in skin color in order to determine whether there is a risk. * Hand massage application is a massage performed with western technique that includes five basic classical massage manipulations including efflorescence, petrissage, friction, tapotment and vibration. * Massage should be performed in a way that creates light pressure on the individual, then the applied pressure should be gradually increased. | Other | Experimental group |
Primary outcome
During the 30. 60th. 90. 120. minutes follow-up, the patient's peripheral capillary refill time, skin integrity, skin color, skin temperature and pain will be evaluated.
Time frame: for 2 hours
Peripheral capillary refill time ( 0-2 sec : + ) ( >2 sec : ++ ) Skin integrity + yes - no If yes, specify: * abrasion * irritation * laceration Specify skin color * Pale/white * red * bruised * pink Skin temperature Compared to unrestricted area * warmer * colder * no difference Pain (0-10 points) Ask the patient about the restricted area 0: I have no pain 10: Unbearable pain 30th min 60th min 90th min 120th min
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 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Physical Restraints and Hand Massage, run by Cukurova 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Jul 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 Ece Kurt (90 0541 272 13 06, ece_ece3543@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
During the 30. 60th. 90. 120. minutes follow-up, the patient's peripheral capillary refill time, skin integrity, skin color, skin temperature and pain will be evaluated. (time frame: for 2 hours). 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 Jul 2025.