NCT07475975

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Upper Extremity Fractures
• Postoperative Anxiety
• Patient Comfort

Interventions

Type	Name	Description
DEVICE	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 mobilization when the elevation pillow is transformed into the arm sling form.
OTHER	Standard postoperative care	Standard care includes the routine use of a standard elevation pillow and a standard cold gel pack available in the clinic.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-11-01
• First posted: 2026-03-17
• Last updated: 2026-03-27

Locations

1 site across 1 country: Turkey (Türkiye)