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

Starting soon · Not applicable

Conditions studied: Upper Extremity Fractures, Postoperative Anxiety, Patient Comfort

In brief

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.

Key facts

Study ID

NCT07475975

Run by

Istanbul University - Cerrahpasa

People needed

80

Starts

2026-09-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-07

Who can join

Age: 7 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital — Istanbul, Sarıyer, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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