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Набор скоро начнётся NCT07128056

Effect of Mobile Phone Video Games on Preoperative Anxiety and Postoperative Pain in Children

Без фазы С лечением Preoperative Anxiety Postoperative Pain Elective Surgical Procedure

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: Mobile phone video game distraction, Standard peri operative care.
Кому может быть актуально
Состояния в реестре: Preoperative Anxiety, Postoperative Pain, Elective Surgical Procedure. Базовые параметры: 3 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
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Mobile Phone Video Games on Preoperative Anxiety and Postoperative Pain in Children Undergoing Elective Surgery

Обзор

This randomized controlled trial will evaluate the effect of mobile phone video game distraction on preoperative anxiety and postoperative pain in pediatric surgical patients. Children aged 3-12 years undergoing elective surgery under general anesthesia will be randomly assigned to either a video game distraction group or a control group receiving standard perioperative care. The primary outcomes are preoperative anxiety levels and postoperative pain scores. The study aims to determine whether a simple, low-cost behavioral intervention can improve perioperative experiences in children

Подробное описание

Preoperative anxiety and postoperative pain are common problems among pediatric patients undergoing surgery. Children often experience high levels of anxiety before a surgical procedure, and this preoperative anxiety can have long-term negative outcomes. Surgical tissue damage leads to moderate to severe postoperative pain, and preoperative anxiety is a significant predictor of postoperative pain. Inadequate pain management can result in delayed recovery, diminished quality of life, increased healthcare costs, and higher healthcare utilization.

Both pharmacological and non-pharmacological methods are used to manage preoperative anxiety and postoperative pain. However, pharmacological medications may have undesirable side effects, and non-pharmacological interventions such as music therapy, clown presence, or parental presence may not be feasible in the operating theatre environment.

Video games (VGs) are increasingly used in healthcare as distraction tools and for behavior modification therapy. Mobile phones are widely available, and playing video games has become a common activity in society. Children can become deeply engaged in playing VGs, which may reduce their awareness of the surgical environment and lower their anxiety levels. Reduced preoperative anxiety may, in turn, lead to decreased postoperative pain.

There is a lack of local research on the use of mobile phone video games in pediatric perioperative care. This study aims to evaluate the effect of mobile phone video games in reducing preoperative anxiety and postoperative pain, and to determine whether this intervention can be recommended for pediatric surgeries.

A randomized controlled trial will be conducted in the Department of Pediatric Surgery, Services Hospital Lahore, over 12 months. Children aged 3-12 years undergoing low-risk elective surgery will be enrolled. Informed consent will be obtained from parents or guardians. Participants will be randomized via the lottery method into:

* Experimental group: Mobile phone video game distraction (n=75) * Control group: Standard perioperative care (n=75)

Anxiety will be measured at two points:

* T1: In the preoperative waiting room * T2: After playing video games for 20 minutes, before induction of anesthesia in the operating room

The Modified Yale Preoperative Anxiety Scale - Short Form (m-YPAS-SF) will be used, where scores range from 22.92 to 100, with lower scores indicating lower anxiety. Postoperative pain will be assessed in the ward using the Revised Faces Pain Scale (r-FACES).

Data will be analyzed using SPSS v25. Numerical variables will be summarized as mean ± standard deviation, and categorical variables as frequencies and percentages. Independent sample t-tests will be used for numerical variables, and Chi-square tests for categorical variables. Data will be stratified for age, gender, and weight to control for effect modifiers. A p-value ≤ 0.05 will be considered statistically significant.

Preoperative anxiety management is a relatively neglected area in Pakistan, and international recommendations are not always applicable in resource-limited settings. The findings from this single-center clinical trial will provide evidence for local clinical practice and may serve as a framework for developing regional protocols to prevent adverse postoperative outcomes.

Limitations: Single-center design and the need for additional staff and time to conduct the study

Вмешательства

  • Поведенческое Mobile phone video game distraction
    Children in the intervention group will play age-appropriate, non-violent mobile phone video games for approximately 20 minutes before induction of anesthesia. This is intended as a distraction technique to reduce preoperative anxiety and improve postoperative pain outcomes. Participants will also receive standard perioperative care.
  • Другое Standard peri operative care
    Standard preoperative and postoperative care according to institutional protocol, without mobile phone video game distraction.

Первичные конечные точки

  • Preoperative Anxiety Level [Срок оценки: Measured twice - (T1) in the preoperative waiting area before intervention, and (T2) after 20 minutes of mobile phone video game distraction, immediately before induction of anesthesia.]
  • Postoperative Pain Intensity [Срок оценки: It will be measured at 1 and 12 hours after surgery in the ward.]

Критерии участия

Критерии включения

  • Age 3-12y
  • Children undergoing elective surgery
  • Has access to a Mobile phone
  • Is able to speak in urdu
  • Children with no contraindications for the use of video games

Критерии исключения

  • Children with previous surgical experience
  • Children with cognitive and learning disabilities
  • Children with a chronic illness/pain that required special medical care
  • Not familiar with video games

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Пакистан · 1 центр
  • Department of Pediatric Surgery ,Services Institute of Medical Sciences/Services Hospital — Lahore

Публикации

  • Bezgin S, Kuyulu S, Atıcı A. Investigation of the effect of video-based game application on acute pain in children under surgery. Journal of Health Sciences and Medicine. 2025;8(1):115-118. doi:10.32322/jhsm.123456
  • Teruel J, Stafford G, Brown J, Jones B, Hopkins M, Johnson A, Edenfield J, Guo A, Schammel C, Renfro S, Nisonson A. Reduction of perioperative anxiety using a hand-held video game device: A randomized study. Perioperative Care and Operating Room Management. 2021 Dec;24:100203. doi:10.1016/j.pcorm.2021.100203.
  • Rostami E, Khanjari S, Haghani H, Amirian H. Effect of video games on preoperative anxiety in 3- to-6-year-old of a sample of Iranian children undergoing elective surgery. J Educ Health Promot. 2022 Apr 28;11:135. doi: 10.4103/jehp.jehp_455_21. eCollection 2022. PMID 35677284
  • Mustafa MS, Shafique MA, Zaidi SDEZ, Qamber A, Rangwala BS, Ahmed A, Zaidi SMF, Rangwala HS, Uddin MMN, Ali M, Siddiq MA, Haseeb A. Preoperative anxiety management in pediatric patients: a systemic review and meta-analysis of randomized controlled trials on the efficacy of distraction techniques. Front Pediatr. 2024 Feb 19;12:1353508. doi: 10.3389/fped.2024.1353508. eCollection 2024. PMID 38440185
  • Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920. PMID 16882820
  • Ali MA, Khan MH, Salim B. Comparing Pharmacological and Nonpharmacological Interventions for Alleviating Preoperative Anxiety in Pediatric Surgical Patients: A Randomized Controlled Trial in Pakistan. Cureus. 2025 Apr 18;17(4):e82502. doi: 10.7759/cureus.82502. eCollection 2025 Apr. PMID 40385813

Идентификаторы

NCT: NCT07128056 · PEDS-ANXPAIN-2025-01 · IRB/2024/1434/SIMS

Первоисточники (государственные реестры)

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