An interventional study of Cold and arm sling elevation pillow and Standard postoperative care in Upper Extremity Fractures, Postoperative Anxiety and Patient Comfort, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Supportive care
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:
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:
Experimental Arm
Description: A multi-functional device based on Kolcaba's Comfort Theory that integrates three components:
Active Comparator Arm
Description: Routine postoperative care according to hospital protocol, including:
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's planned enrollment of 80 is below the median of 150 across 184 interventional studies indexed under Common Cold.
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Exclusion Criteria:
Participants in this group will receive the 'Cold and Arm Sling Elevation Pillow' intervention. This specially designed supportive device integrates three functions: cold application, limb elevation, and arm sling support. The intervention will be applied in the postoperative period to improve patient comfort and reduce anxiety levels
Device: Cold and arm sling elevation pillow
Participants in this group will receive standard postoperative nursing care as per the hospital's routine protocol. This includes elevation of the affected extremity using a standard pillow, cold application using ice gel packs wrapped in gauze, and the use of a standard arm sling during mobilization.
Other: Standard postoperative care
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.
Also known as: Experimental group
Standard care includes the routine use of a standard elevation pillow and a standard cold gel pack available in the clinic.
Also known as: Control group
Comfort
Comfort will be assessed using the Child Comfort Behavior Checklist. The scale consists of five sub-dimensions ("Vocalizations," "Motor Symptoms," "Performance," "Facial Expressions," and "Other") with a total of 30 items. Items are scored on a 5-point Likert-type scale, ranging from 0 to 4 (Not applicable=0, None=1, Slightly=2, Moderate=3, Strong=4). During the scoring phase, items scored as "0" (not applicable to the child's age or condition) are excluded from the total score calculation. The child's actual score is determined by dividing the total points by the potential maximum score achievable for that specific child. The maximum possible score for the scale is 100, where higher scores indicate higher levels of comfort (a more positive outcome).
Time frame: 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.
Postoperative anxiety
State anxiety will be assessed using the State-Trait Anxiety Inventory for Children (STAI-C). Reverse-scored items will be scored according to standard scoring guidelines, with total scores ranging from 20 to 60, where higher scores indicate higher levels of state anxiety (representing a more negative outcome).
Time frame: 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.
Plan to share: No — Individual participant data (IPD) will not be shared to protect the privacy and confidentiality of the pediatric participants and their families. Furthermore, as this study is part of a doctoral thesis project, the data are restricted for use in the current research and its associated academic publications according to the approved ethical protocol.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 49 interventional studies with no phase under Common Cold, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's planned 12 months is above that.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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