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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Anxiety; Patient Comfort; Upper Extremity Fractures
• Intervention / Treatment: Device: Cold and arm sling elevation pillow; Other: Standard postoperative care

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

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: İlke Karabıyık Demir, PhD Student; Phone Number: +905419762442; Email: ilkekarabyk@gmail.com

Study Locations

• Turkey (Türkiye)
  • Sarıyer
    • Istanbul, Sarıyer, Turkey (Türkiye)
      • Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital
      • Contact: İlke Karabıyık Demir; Phone Number: +905419762442; Email: ilkekarabyk@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cold and arm sling elevation pillow group; 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; 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
Other: Control Group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Collaborators: Baltalimani Bone Diseases Research and Training Hospital
• Investigators: Principal Investigator: Seda Çağlar, Assoc. Prof. Dr., Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: children; Upper Extremity Fracture; Patient Comfort; Postoperative Anxiety; Cold and arm sling elevation pillow
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 1395301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No