An interventional study of Evulation and Application of physical restraint material in Edema, Dermatologic Complication and Physical Restraints, sponsored by Kocaeli City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Kocaeli City Hospital · Not applicable, Interventional, and Prevention
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.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's planned enrollment of 76 is above the median of 52 across 401 interventional studies indexed under Edema.
Browse Edema studies →Kocaeli City Hospital is the lead sponsor of 44 studies on the registry; 19 are open to participants now.
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18 years of age or older,
Exclusion Criteria:
In the physical restraint area;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in this group will receive routine intensive care unit nursing care without implementation of the structured care bundle.
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.
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.
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.
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.
edema, ecchymosis, laceration, ulceration
The rates of edema, ecchymosis, laceration and ulceration developing in the restricted area in the days following physical restriction.
Time frame: From the initiation of physical restraint to the 5th day.
Plan to share: No — Patient data will only be used for statistical analysis.
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Mar 2027, 12 months later.
Of 153 non-industry interventional studies with no phase under Edema, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 12 months is close to that.
Counting every sponsor, half of 168 studies reached it within 11 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Kocaeli City Hospital