The Effect of the Cold Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorIstanbul University - Cerrahpasa
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cold and arm sling elevation pillow
DeviceThis 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.
Standard postoperative care
Other interventionStandard care includes the routine use of a standard elevation pillow and a standard cold gel pack available in the clinic.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Cold and arm sling elevation pillow groupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul University - Cerrahpasa
Lead sponsor
Baltalimani Bone Diseases Research and Training Hospital
Collaborator
Source ClinicalTrials.gov
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