Идёт набор NCT06622369

The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision

Без фазы С лечением Virtual Reality

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Virtual Reality-Game group, Virtual Reality-Cartoon-video group.
Кому может быть актуально: Состояния в реестре: Virtual Reality. Базовые параметры: 7 лет — 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision: A Randomized Controlled Study

Обзор

The aim of this study is to investigate the effect of virtual reality and cartoons and games on the anxiety, fear and post-procedural pain levels of children aged 7-12 years who will undergo circumcision. The population of the study will consist of children aged 7-12 years who are planned to undergo circumcision in the pediatric urology clinic of İzmir Bakırçay University Çiğli and Training and Research Hospital between September 2024 and September 2025. The sample of the study will consist of children who meet the inclusion criteria on the specified dates and whose parents/legal guardians and themselves agree to participate in the study. Descriptive Characteristics Form, Vital Symptom Form, Child Fear Scale, Child Anxiety Scale-Disposition (CAS-D) and Child Fear Scale will be used to collect the data.

Подробное описание

Virtual Reality-Game group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the game group will be allowed to choose a game compatible with virtual reality. Children in this group will be allowed to play the game of their choice for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.

Virtual Reality-Cartoons-Video group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the cartoon-video group will be allowed to choose a cartoon of their choice compatible with virtual reality. Children in this group will be allowed to watch the cartoon of their choice for 10-15 minutes before the procedure. In terms of infection risk, VR will be disinfected before and after each use.

Control group Children in the control group will not be subjected to any distraction method. The routine procedure of the clinic will be applied.

Data Collection Phase 1: The study will start after ethics committee and institutional permissions are obtained. The researcher will inform the children and their parents about the study and the verbal and written consent of the participants will be obtained. Children who will undergo circumcision will be randomly assigned to the VR groups or the control group.

Phase 2: "Descriptive Characteristics Form", 'Child Fear Scale', 'Child Anxiety Scale-Conditionality (CAS-D)' will be completed for children in all groups before the circumcision procedure.

Phase 3: Children in the VR-game group will be asked to play a game of their choice for 10-15 minutes before the procedure. Children in the VR-cartoon-video group will be asked to watch a cartoon of their choice for 10-15 minutes.

Stage 4: Before the procedure, the physiologic parameters of the children in all groups will be recorded on the "Vital Signs Record Form".

5\. After the procedure, "Child Fear Scale", "Child Anxiety Scale-Conditioning (CAS-D)" and "Visual Analog Scale" and "Life Findings Record Form" will be filled out for the children in all groups.

Вмешательства

Другое Virtual Reality-Game group
Children in the play group will be allowed to choose a game that is compatible with virtual reality. Children in this group will be allowed to play the game they want for 10-15 minutes before the procedure. VR will be disinfected before and after each use
Другое Virtual Reality-Cartoon-video group
Children in the cartoon-video group will be allowed to choose a cartoon they want compatible with virtual reality. Children in this group will be allowed to watch the cartoon they want for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.

Первичные конечные точки

Fear assesed by Child Fear Scale [Срок оценки: Procedure -Before the circumcision]
Fear assesed by Child Fear Scale [Срок оценки: Procedure -After the circumcision]
Anxiety assesed by Children Anxiety Meter-State [Срок оценки: Procedure -Before the circumcision]
Anxiety assesed by Children Anxiety Meter-State [Срок оценки: Procedure -After the circumcision]
Visual Analog Scale [Срок оценки: Procedure -After the circumcision]

Вторичные конечные точки (6)

Children's heart rate [Срок оценки: Procedure -Before the circumcision]
Children's heart rate [Срок оценки: Procedure -After the circumcision]
Children's respiratory rate [Срок оценки: Procedure -Before the circumcision]
Children's respiratory rate [Срок оценки: Procedure -After the circumcision]
Children's oxygen saturation [Срок оценки: Procedure -Before the circumcision]
Children's oxygen saturation [Срок оценки: Procedure -After the circumcision]

Критерии участия

Критерии включения

Children between the ages of 7 and 12,
The parent/legal guardian or the child himself/herself agrees to participate in the study
Has not undergone any surgical operation before
He was hospitalized for a circumcision
No communication problems (visual, hearing, mental)