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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• modified Yale Preoperative Anxiety Scale [Срок оценки: 1 day]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Turkey (Türkiye) · 1 центр

• Uludağ Üniversitesi — Bursa

Идентификаторы

NCT: NCT06250816 · 2023-28/21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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