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NCT Number: NCT06250816

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

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uludağ Üniversitesi

Bursa, Turkey (Türkiye)

Location status: Recruiting

Location contact

Leman Gökçenur Aydın

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. modified Yale Preoperative Anxiety Scale

    Time frame: 1 day

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

Study contacts

Contact information is provided by the study sponsor or research team.

Leman Gökçenur Aydın, MD

CONTACT

[email protected]

+905532043332

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 9, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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