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

NCT07475975 | Not Yet Recruiting

• 1 other identifier: 1395301
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Extremity Fractures; Postoperative Anxiety; Patient Comfort

Keywords

Postoperative Anxiety; Patient Comfort; Upper Extremity Fracture; Cold and arm sling elevation pillow; children

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Cold and arm sling elevation pillow group

EXPERIMENTAL

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

Control Group

OTHER

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

Interventions

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.

Also known as: Experimental group

Cold and arm sling elevation pillow 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.

Also known as: Control group

Control Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Baltalimani Bone Diseases Research and Training Hospital: collaborator

Study Sites (1)

Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital

Istanbul, Sarıyer, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Common Cold

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Seda Çağlar, Assoc. Prof. Dr.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İlke Karabıyık Demir, PhD Student

CONTACT

+905419762442; ilkekarabyk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Specialist (Phd Stutdent - Doctoral Candidate)

Model Details: 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).

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: March 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)