The Effect of the Cold Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Children

Официальное название

The Effect of Cold and Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Pediatric Upper Extremity Fractures

Обзор

The purpose of this clinical trial is to learn whether the use of a "cold and arm sling elevation pillow" affects anxiety and comfort levels in children aged 7-12 years undergoing surgery for upper extremity fractures. The main questions it aims to answer are: * Does the use of a cold and arm sling elevation pillow reduce postoperative anxiety levels in children? * Does the use of a cold and arm sling elevation pillow increase postoperative comfort levels in children? Researchers will compare the experimental group (using the specially designed cold and arm sling elevation pillow) with the control group (receiving standard clinical care, including standard pillows and separate ice packs) to see the effects of the integrated pillow on anxiety and comfort. Participants will: * Receive education before surgery based on their randomly assigned group (experimental or control), * Use the assigned elevation and cold application method for the first 24 hours following surgery, * Complete anxiety and comfort assessment scales at four different time points: before the intervention, just before surgery, 6 hours after surgery, and at the time of discharge.

Подробное описание

Experimental Arm

* Intervention Name: Cold and Arm Sling Elevation Pillow * Description: A multi-functional device based on Kolcaba's Comfort Theory that integrates three components:

1. Elevation Module: Maintains the limb above heart level to reduce postoperative edema. 2. Cold Application Module: Waterproof sleeve with velcro fasteners for intermittent cold gel pack application (15-20 minutes per hour for the first 24 hours). 3. Arm Sling Function: Adjustable straps allow the pillow to function as a stabilizer during mobilization. The device features a child-friendly "teddy bear" design to reduce medical anxiety.

Active Comparator Arm

* Intervention Name: Standard Clinical Care * Description: Routine postoperative care according to hospital protocol, including:

1. Elevation: Using standard hospital bed pillows to support the limb. 2. Cold Application: Separate ice gel packs wrapped in gauze/towels, applied for 15-20 minutes every hour for the first 24 hours. 3. Stabilization: Use of a standard fabric arm sling during patient mobilization

Вмешательства

• Устройство Cold and arm sling elevation pillow
  This intervention consists of a combined, non-pharmacological nursing approach that includes cold therapy, an arm sling, and an elevation pillow. The cold therapy, planned to reduce postoperative edema and pain, is designed to be integrated into the elevation pillow in a manner compatible with the arm sling. The elevation pillow used in this intervention is suitable for cold therapy and can be easily converted into an arm sling when needed. In addition, cold therapy can be maintained during mobi
• Другое Standard postoperative care
  Standard care includes the routine use of a standard elevation pillow and a standard cold gel pack available in the clinic.

Первичные конечные точки

• Comfort [Срок оценки: Measurements will begin one day before surgery and continue on the morning of surgery in the preoperative period. Postoperative measurements will be conducted at 6 hours after surgery and on the first postoperative day prior to discharge.]
• Postoperative anxiety [Срок оценки: Measurements will begin one day before surgery and continue on the morning of surgery in the preoperative period. Postoperative measurements will be conducted at 6 hours after surgery and on the first postoperative day prior to discharge.]

Критерии участия

Критерии включения

• Children aged 7-12 years
• Scheduled for elective surgery with a diagnosis of upper extremity fracture
• Planned to receive analgesic treatment every 8 hours (three times daily) for postoperative pain management
• Fully oriented and without any condition that would impair communication or cooperation
• Expected to have a hospital stay of at least 24 hours in the orthopedic wards where the study is conducted
• Children and their parents/legal guardians who provide consent to participate in the study

Критерии исключения

• Undergoing emergency surgical intervention
• Presence of an open wound, infection, suspected compartment syndrome, or vascular injury at the fracture site
• Presence of sensory loss or neurological deficit in the affected extremity
• Presence of cognitive, hearing, speech, or severe physical disabilities
• Treated conservatively with cast immobilization
• Planned postoperative analgesic regimens that are more frequent or less frequent than every 8 hours, or that require high-dose analgesic therapy
• Requiring revision surgery
• Presence of metabolic or neuromuscular comorbidities (e.g., osteogenesis imperfecta, recurrent fractures)
• Children whose mothers are unable to communicate or do not speak Turkish

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07475975 · 1395301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗