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

NCT06250816 | Recruiting

• 1 other identifier: 2023-28/21
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The operating room environment can be frightening for pediatric patients. Many techniques have been used to make the operating room environment less intimidating, including allowing parents to accompany part of this procedure, play therapy and various distraction strategies during the entrance to the operating room. In a survey study, it was reported that parents were expected to create hospital conditions with a more child-friendly atmosphere. In this context, it is thought that creating a warmer environment for children, including the clothes worn in the operating room, may reduce the anxiety level of children. In this study, investigators' aim was to investigate the effect of wearing an hospital gown with cartoon characters on the reduction of preoperative anxiety in children scheduled for Orthopedic surgery by in the operating room.

Conditions

Anxiety, Preoperative

Outcome Measures

Primary Outcomes (1)

• modified Yale Preoperative Anxiety Scale

  investigators evaluate children using the verified Turkish version of modified Yale Preoperative Anxiety Scale.

  1 day

Study Arms (2)

Children wearing the hospital gown with cartoon characters

EXPERIMENTAL

The experimental group will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using the modified Yale Preoperative Anxiety Scale (m-YPAS). Afterwards, the patient will be asked to choose one of the hospital gowns they want to wear and put it on with parental assistance.

Other: The hospital gown with cartoon characters

Children with standard hospital gown

NO INTERVENTION

The control group will have a preoperative visit, the investigator will meet the patient and assess the child's anxiety level using m-YPAS. The patient will be asked to wear the hospital gown used in the hospital in routine practice with parental assistance.

Interventions

The hospital gown with cartoon characters OTHER

The patient will be asked to choose one of the hospital gowns with cartoon characters they want to wear and put it on with parental assistance.

Children wearing the hospital gown with cartoon characters

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludağ Üniversitesi

Bursa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Selcan Akesen, MD

  Uludağ Üniversitesi

  PRINCIPAL INVESTIGATOR

• Leman Gökçenur Aydın, MD

  Uludağ Üniversitesi

  STUDY DIRECTOR

Central Study Contacts

Leman Gökçenur Aydın, MD

CONTACT

+905532043332; lgaydin@uludag.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: February 9, 2024
• Study Start: February 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)