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

NCT07475975 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-07

No results posted yet for this study

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

Interventions

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

Standard postoperative care

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

Sponsors & Collaborators

  • Baltalimani Bone Diseases Research and Training Hospital

    collaborator OTHER_GOV
  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Seda Çağlar, Assoc. Prof. Dr. · Istanbul University - Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2027-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07475975 on ClinicalTrials.gov