The Effect of the Cold Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Children (NCT07475975) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of the Cold Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Children
Turkey (Türkiye)80 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
7 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comfort
Timeframe: 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.
2
Postoperative anxiety
Timeframe: 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.