Effect of Mobile Phone Video Games on Preoperative Anxiety and Postoperative Pain in Children Undergoing Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Preoperative Anxiety Level
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors who score preoperative anxiety (m-YPAS-SF) and postoperative pain (Wong-Baker FACES) will be blinded to participants' group assignment. Clinical staff and participants cannot be blinded due to the nature of the intervention (mobile phone video games). Assessors will be instructed not to ask about the intervention, and data collection will use standardized forms. The statistician performing primary analyses will be blinded to group allocation
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mobile phone video game distraction
Participants will play age-appropriate, non-violent mobile phone video games for approximately 20 minutes before induction of anesthesia as a distraction technique, in addition to receiving standard perioperative care
干预措施: Mobile phone video game distraction (Behavioral)
Mobile phone video game distraction
Participants will play age-appropriate, non-violent mobile phone video games for approximately 20 minutes before induction of anesthesia as a distraction technique, in addition to receiving standard perioperative care
干预措施: Standard peri operative care (Other)
Standard perioperative care
Participants will receive standard perioperative care according to institutional protocols, without exposure to the mobile phone video game distraction
干预措施: Standard peri operative care (Other)
结局指标
主要结局
Preoperative Anxiety Level
时间窗: 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.
Anxiety will be measured at two time points (T1 and T2). At T1, baseline anxiety will be assessed in the preoperative waiting room. Children randomized to the intervention group will then play mobile phone video games for 20 minutes, while the control group will not. At T2, anxiety will be reassessed immediately before induction of anesthesia in the operating room. Anxiety will be measured using the modified Yale Preoperative Anxiety Scale - Short Form (m-YPAS-SF), where scores range from 22.92 to 100, with lower scores indicating lower anxiety.
Postoperative Pain Intensity
时间窗: It will be measured at 1 and 12 hours after surgery in the ward.
Post operative pain management will be standardized and it will be measured at 1 and 12 hours after surgery using revised faces pain scale (FPS-r) in the ward.It consists of six faces showing progressively increasing levels of distress with each face assigned a numerical value 0-10.
Preoperative Anxiety Level
时间窗: 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.
Anxiety will be measured at two time points (T1 and T2). At T1, baseline anxiety will be assessed in the preoperative waiting room. Children randomized to the intervention group will then play mobile phone video games for 20 minutes, while the control group will not. At T2, anxiety will be reassessed immediately before induction of anesthesia in the operating room. Anxiety will be measured using the modified Yale Preoperative Anxiety Scale - Short Form (m-YPAS-SF), where scores range from 22.92 to 100, with lower scores indicating lower anxiety.
Postoperative Pain Intensity
时间窗: It will be measured at 1 and 12 hours after surgery in the ward.
Post operative pain management will be standardized and it will be measured at 1 and 12 hours after surgery using revised faces pain scale (FPS-r) in the ward.It consists of six faces showing progressively increasing levels of distress with each face assigned a numerical value 0-10.
次要结局
未报告次要终点
研究者
Fatima Numeri
Professor of Paediatric surgery
Services Institute of Medical Sciences, Pakistan