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

Официальное название

Development and Evaluation of the Effectiveness of a Dermatological Complications and Edema Prevention Care Package in the Physical Constraint Zone

Обзор

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.

Вмешательства

• Другое Evulation
  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 ph
• Другое Application of physical restraint material
  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 li
• Другое Elevation
  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 maint
• Другое Hand massage
  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.

Первичные конечные точки

• edema, ecchymosis, laceration, ulceration [Срок оценки: From the initiation of physical restraint to the 5th day.]

Критерии участия

Критерии включения

• • 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.

Критерии исключения

• 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.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Kocaeli City Hospital — Kocaeli

Идентификаторы

NCT: NCT07442344 · 2025-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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