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Not Yet Recruiting NCT07475975

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

Conditions: Upper Extremity Fractures, Postoperative Anxiety, Patient Comfort

Sex: All
Ages: 7 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Istanbul University - Cerrahpasa

Location: Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital Istanbul Sarıyer

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07475975). StuddyBuddy aggregates publicly available trial information.