Upper Extremity Fractures, Postoperative Anxiety, Patient Comfort
Conditions
Keywords
Postoperative Anxiety, Patient Comfort, Upper Extremity Fracture, Cold and arm sling elevation pillow, children
Brief 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.
Detailed description
Experimental Arm * Intervention Name: Cold and Arm Sling Elevation Pillow * Description: A multi-functional device based on Kolcaba's Comfort Theory that integrates three components: 1. Elevation Module: Maintains the limb above heart level to reduce postoperative edema. 2. Cold Application Module: Waterproof sleeve with velcro fasteners for intermittent cold gel pack application (15-20 minutes per hour for the first 24 hours). 3. Arm Sling Function: Adjustable straps allow the pillow to function as a stabilizer during mobilization. The device features a child-friendly "teddy bear" design to reduce medical anxiety. Active Comparator Arm * Intervention Name: Standard Clinical Care * Description: Routine postoperative care according to hospital protocol, including: 1. Elevation: Using standard hospital bed pillows to support the limb. 2. Cold Application: Separate ice gel packs wrapped in gauze/towels, applied for 15-20 minutes every hour for the first 24 hours. 3. Stabilization: Use of a standard fabric arm sling during patient mobilization
Interventions
DEVICECold and arm sling elevation pillow
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.
Standard care includes the routine use of a standard elevation pillow and a standard cold gel pack available in the clinic.
Sponsors
Istanbul University - Cerrahpasa
Baltalimani Bone Diseases Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
To ensure the objectivity of the study findings, a single-blind design is employed. While the participants and investigators are aware of the intervention due to its physical nature, the data collector (outcome assessor) is a clinical nurse who is blinded to the group assignments of the children. This assessor performs the observations and administers the scales (STAIC and CCBC) without knowledge of whether the child is in the experimental or control group.
Intervention model description
This is a randomized controlled experimental study with a parallel-group design. Participants are assigned to either the experimental group (Cold and arm sling elevation pillow intervention) or the control group (standard clinical care) using a block randomization method. To prevent observer bias, the study is single-blinded; the data collector (outcome assessor) is a clinical nurse who is unaware of the group assignments. Data are collected at four distinct time points: baseline (T0), pre-surgery (T1), 6 hours post-surgery (T2), and at discharge (T3).
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 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. | 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). |
| Postoperative anxiety | 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. | 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). |
Countries
Turkey (Türkiye)
Contacts
CONTACTİlke Karabıyık Demir, PhD Student
PRINCIPAL_INVESTIGATORSeda Çağlar, Assoc. Prof. Dr.
Istanbul University - Cerrahpasa
Outcome results
None listed