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NCT Number: NCT07475975

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

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.

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Key information

Conditions

Upper Extremity Fractures Common Cold Infections Patient Comfort Picornaviridae Infections Postoperative Anxiety RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital

Istanbul, Sarıyer, Turkey (Türkiye)

Location contact

İlke Karabıyık Demir

CONTACT

[email protected]

+905419762442

About this study

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:
  • Elevation Module: Maintains the limb above heart level to reduce postoperative edema.
  • Cold Application Module: Waterproof sleeve with velcro fasteners for intermittent cold gel pack application (15-20 minutes per hour for the first 24 hours).
  • 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:
  • Elevation: Using standard hospital bed pillows to support the limb.
  • Cold Application: Separate ice gel packs wrapped in gauze/towels, applied for 15-20 minutes every hour for the first 24 hours.
  • Stabilization: Use of a standard fabric arm sling during patient mobilization

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold and arm sling elevation pillow

Device

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.

Other names: Experimental group

Standard Postoperative Care

Other

Standard care includes the routine use of a standard elevation pillow and a standard cold gel pack available in the clinic.

Other names: Control group

Primary outcomes

  1. Comfort

    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.

    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).

  2. Postoperative anxiety

    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.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

İlke Karabıyık Demir, PhD Student

CONTACT

[email protected]

+905419762442

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Baltalimani Bone Diseases Research and Training Hospital

Registry information

Official study title

The Effect of Cold and Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Pediatric Upper Extremity Fractures

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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