Loading clinical trials...
Loading clinical trials...
The Effect of Cold and Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Pediatric Upper Extremity Fractures
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.
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
Age
7 - 12 years
Sex
ALL
Healthy Volunteers
No
Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital
Istanbul, Sarıyer, Turkey (Türkiye)
Start Date
April 1, 2026
Primary Completion Date
April 1, 2027
Completion Date
November 1, 2027
Last Updated
March 17, 2026
80
ESTIMATED participants
Cold and arm sling elevation pillow
DEVICE
Standard postoperative care
OTHER
Lead Sponsor
Istanbul University - Cerrahpasa
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions