Care Bundle for Prevention of Skin Complications and Edema in Restrained Patients

NCT07442344 | Not Yet Recruiting

• 1 other identifier: 2025-203
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Physical restraint (restraint) is defined as the restriction of a patient's free body movements and the prevention of the patient's ability to move easily by healthcare professionals using physical or mechanical devices to prevent the patient from harming themselves or others. Physical restraints can be used by healthcare professionals for many purposes, particularly in intensive care units, such as ensuring patient safety, controlling aggressive and disruptive behavior, continuing patient care and treatment, and preventing the removal of medical equipment attached to the patient. However, when looking at the duration of physical restraint applications, it has been determined that they vary between 3-4 days. The longer the duration of physical restraint, the greater the likelihood of complications developing. In particular, long-term physical restraint can result in neurovascular and dermatological complications such as pressure injuries, edema, ecchymosis, redness, numbness, limited movement, increased temperature, discoloration, and nerve damage. The care package application is a model that improves patient care quality by simultaneously and comprehensively implementing 3-5 applications based on strong scientific evidence, prepared for the relevant area in the specified patient group. Care package applications are created to enable evidence-based practices outlined in guidelines to be used more effectively and practically in clinical settings. Within this context, the aim of this study is to develop a care package to prevent dermatological complications and edema that may occur in the restraint area in patients undergoing physical restraint in intensive care and to evaluate the effectiveness of this care package.

Conditions

Edema; Dermatologic Complication; Physical Restraints

Keywords

physical restraint; edema; laseration; ulceration; intensive care unit; nursing; ecchymosis

Outcome Measures

Primary Outcomes (1)

• edema, ecchymosis, laceration, ulceration

  The rates of edema, ecchymosis, laceration and ulceration developing in the restricted area in the days following physical restriction.

  From the initiation of physical restraint to the 5th day.

Study Arms (2)

Care Bundle

EXPERIMENTAL

Participants in this group will receive structured dermatological complications and an Edema Prevention Care Package in the physical restraint area, in addition to routine nursing care in the intensive care unit.The care package group includes: assessment of the area of physical restraint, application of physical restraint to the upper extremities (both wrists), massage, and elevation.

Other: Evulation; Other: Application of physical restraint material; Other: Elevation; Other: Hand massage

routine care

NO INTERVENTION

Participants in this group will receive routine intensive care unit nursing care without implementation of the structured care bundle.

Interventions

Evulation OTHER

1. Consent is obtained from the patient's relatives for the application of physical restraint/the consent obtained is verified. 2. Before initiating physical restraint and every 2 hours during the period of physical restraint, the restraint area is assessed for laseration, ulceration, ecchymosis, erythema, numbness, pain, increased temperature, color change, capillary refill time, and fluctuations in peripheral pulse, and the findings are recorded. 3. If any of these findings are present, the physician is notified and physical restraint is not applied. 4. If any of these findings develop during the period of physical restraint, the physician is notified, physical restraint is discontinued, and the finding is recorded. 5. The indication for restraint is reviewed every 8 hours.

Care Bundle

Application of physical restraint material OTHER

1. Physical restraint is performed using a single-use restraint bandage. 2. The bandage is wrapped around the patient's wrist, adjusting the distance between the bandage and the wrist to 2 cm (approximately 2 fingers' width). 3. The ties of the restraint bandage are secured to the bed rail at a point that the patient cannot reach or untie. 4. If there is an arterial catheter/peripheral venous catheter in the restraint area, the restraint material is placed so as not to apply pressure to these lines to ensure the safety of the area and preserve vascular integrity; the flow and patency of the lines are checked at regular intervals during restraint.

Care Bundle

Elevation OTHER

1. While physical restriction continues, elevation at a 30-degree angle is applied to the restricted area 5 times a day, for 30 minutes each time. 2. Elevation is applied by placing the forearm (the area between the elbow and fingertips) on the elevation pillow while the patient is lying on their back or side. 3. The elbow is placed at the lowest angle point between the elevation pillow and the floor, and the fingertips are placed at the highest angle point. 4. The patient's safety and the maintenance of the extremity position are assessed hourly during the elevation period.

Care Bundle

Hand massage OTHER

1. While the physical restriction continues, the restriction band is loosened and a hand massage is applied to the restricted hand once a day for 15 minutes each time. 2. Before starting the massage, moisturizing cream is applied to the physically restricted area, followed by stroking and kneading exercises from distal to proximal in the direction of the heart. 3. The massage begins with light pressure, which is gradually increased.

Care Bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 18 years of age or older,
• For whom a physician has decided to apply physical restraint to the upper extremities and is about to begin doing so,
• With intact skin integrity in the area of physical restraint (no lacerations, wounds, ulcerations),
• Without oedema in the area of physical restraint,
• APACHE-2 score of 17 or higher (In the study by Tian et al. (2022), an APACHE-II score of 17 or higher was found to be associated with a low life expectancy),
• Individuals for whom written consent has been obtained from the patient's relatives regarding participation in the study.

You may not qualify if:

• In the physical restraint area;
• Those with fractures or dislocations,
• Those with peripheral vascular disease or chronic venous insufficiency,
• Those with advanced skin disease (psoriasis, etc.),
• Those whose physical restraint was discontinued within the first 24 hours after it began for any reason (discharge, transfer to another clinic, death, lifting of the physical restraint decision by the physician, etc.).

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Edema; Ulcer; Ecchymosis

Interventions

Hindlimb Suspension

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Skin Manifestations

Intervention Hierarchy (Ancestors)

Restraint, Physical; Immobilization; Investigative Techniques; Weightlessness Simulation; Space Simulation; Environment, Controlled; Environment; Environment and Public Health

Central Study Contacts

pınar erman, PhD candidate

CONTACT

+905469417295; pinarugurag@gmail.com

Ayşe Ozkaraman, Professor

CONTACT

+90 239 375 0154; aozaydin26@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pınar Erman

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)