Actively Recruiting

Phase Not Applicable
Age: 4Years - 12Years
All Genders
ID06250816

The Effects of Wearing Operation Gown With Cartoon Characters on Reducing Preoperative Anxiety in Children: Randomized Controlled Study

Led by Uludag University · Updated on 2024-10-08

160

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether wearing hospital gowns with cartoon characters can reduce preoperative anxiety in children aged 4 to 12 years who are scheduled for orthopedic surgery. The study recognizes that the operating room can be a frightening place for pediatric patients and explores a child-friendly environment approach, including the clothing worn during surgery, to help ease anxiety. Children participating in the study will be randomly assigned to one of two groups. One group will choose and wear a hospital gown featuring cartoon characters, while the other group will wear the standard hospital gown used in routine practice. Anxiety levels will be measured before and after gown selection using the modified Yale Preoperative Anxiety Scale (m-YPAS). Vital signs, analgesic use, and surgery duration will also be recorded. Participants will be assessed during a preoperative visit and again in the operating room before anesthesia induction. Parents' satisfaction with the process will be evaluated as well. The trial involves close monitoring of anxiety levels and surgical details to understand the impact of the gown choice on children's comfort and stress during surgery.

CONDITIONS

Brief Title

The Effects of Wearing Operation Gown With Cartoon Characters on Reducing Preoperative Anxiety in Children: Randomized Controlled Study

Who Can Participate

Age: 4Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who are planned to have elective orthopedic surgery
  • Patients whose American Society of Anesthesiologists (ASA) physical status classification are between 1-3
  • Patients who have approved the informed consent form
Not Eligible

You will not qualify if you...

  • Motor and/or mentally retarded patients
  • Patients with hearing-speech impairment
  • Patients whose ASA physical status classification IV-V
  • Patients who do not accept informed consent and/or refused to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants have a preoperative visit where their anxiety level is assessed. They then wear either a hospital gown with cartoon characters or a standard hospital gown with parental assistance before surgery.

1 preoperative visit and 1 visit before anesthesia induction

Follow-up

Duration - Postoperative period on the day of surgery

After surgery, parental satisfaction and other measures such as vital signs and analgesic use are evaluated.

1 postoperative assessment

Trial Site Locations

Total: 1 location

1

Uludağ Üniversitesi

Bursa, Turkey (Türkiye)

Actively Recruiting

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Research Team

L

Leman Gökçenur Aydın, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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