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

Istanbul University - Cerrahpasa

Status: Not yet enrolling

Conditions: Patient Comfort; Postoperative Anxiety; Upper Extremity Fractures

Treatments: Other: Standard postoperative care; Device: Cold and arm sling elevation pillow

Study type: Interventional

Funder types: Other

Identifiers

NCT07475975

1395301

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Cold and arm sling elevation pillow group

Experimental group

Description:

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

Treatment:

Device: Cold and arm sling elevation pillow

Control Group

Other group

Description:

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.

Treatment:

Other: Standard postoperative care