NCT07070505

Brief 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. 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?

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

June 3, 2025

Last Update Submit

July 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    for 2 hours

Study Arms (2)

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.

Other: Experimental

Interventions

* 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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ekrem Tok Mental Health Hospital

Adana, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer PhD

Study Record Dates

First Submitted

June 3, 2025

First Posted

July 17, 2025

Study Start

June 10, 2025

Primary Completion

September 10, 2025

Study Completion

October 10, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

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