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

NCT ID: NCT06250816

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-02-01

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.

Detailed Description

Pediatric patients aged between 4-12 years, who are planned to be operated by the Orthopedic Surgery Clinic in Bursa Uludag University Faculty of Medicine Hospital Surgical Theatre, will be randomized preoperatively by closed envelope method. One 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. The other group also 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. Then the patients will be taken to the operating room as in the routine procedure. Before induction of anesthesia in the operating room, another investigator will re-evaluate the child's anxiety level using the m-YPAS scale. Vital signs, analgesic use and duration of surgery will be recorded during the operation. Afterwards, the satisfaction level of the parents will be evaluated.

Conditions

Anxiety, Preoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Children wearing the hospital gown with cartoon characters

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.

Group Type: EXPERIMENTAL

The hospital gown with cartoon characters

Intervention Type: 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 with standard hospital gown

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The hospital gown with cartoon characters

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uludag University

OTHER

Sponsor Role: lead

Responsible Party

Selcan Akesen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selcan Akesen, MD

Role: PRINCIPAL_INVESTIGATOR

Uludağ Üniversitesi

Leman Gökçenur Aydın, MD

Role: STUDY_DIRECTOR

Uludağ Üniversitesi

Locations

Uludağ Üniversitesi

Bursa, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Leman Gökçenur Aydın, MD

Role: CONTACT

lgaydin@uludag.edu.tr

+905532043332

Facility Contacts

Leman Gökçenur Aydın

Role: primary

Other Identifiers

2023-28/21

Identifier Type: -

Identifier Source: org_study_id