A Mobile Application for Child-focused Perioperative Education: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Children's Perioperative Multidimensional Anxiety Scale (CPMAS)
研究概览
简要总结
The investigators developed a child-friendly mobile application to support accessible, interactive patient/caregiver education about pediatric tonsillectomy. This randomized controlled trial aims to evaluate whether the intervention reduces preoperative anxiety, improves patients' confidence and positive coping, improves caregivers' satisfaction and self-efficacy, and reduces call volumes from caregivers to the clinic after surgery compared to current standard care.
详细描述
This is a prospective, questionnaire-based randomized controlled trial to evaluate a child-focused patient education intervention. The investigators developed a child-friendly mobile application to support accessible, interactive patient/caregiver education about pediatric tonsillectomy. Families in the intervention group will be invited to use the "Ready for Tonsillectomy" mobile application on their own mobile devices as they prepare for surgery and during recovery. The trial will compare preoperative anxiety and other patient-centered outcomes between families who use the mobile application (intervention) and families who receive current standard care materials without additional education (control). Primary and secondary endpoints include:
- Patients' preoperative anxiety (primary endpoint)
- Patient-reported confidence in knowing what to expect
- Patient-reported attitudes toward the procedure
- Patient-reported coping strategies
- Postoperative pain in the post-anesthesia care unit
- Caregivers' preoperative anxiety
- Caregivers' satisfaction with educational materials
- Caregivers' self-efficacy in managing their child's postoperative pain.
- Caregiver-initiated phone call volumes to the clinic within 2 weeks after surgery
- Mobile application use/interactions based on integrated user analytics
The target sample size is based on a power analysis using the primary outcome measure, which is validated for ages 7-13 years; the investigators will recruit a total of approximately 180 patients ages 7-13 years along with their caregivers (i.e., 180 caregivers for this cohort). A secondary cohort of patients ages 5-6 years will be enrolled simultaneously until the investigators reach the target sample size for the primary cohort (maximum 180 additional patients in the younger cohort, plus their caregivers). Participants will give informed verbal consent/assent at least 2 weeks before surgery. At this time, the family will be randomly assigned to either the intervention or control arm. Families in the intervention arm will download the mobile application on their smartphone or tablet; they will be able to access the application as frequently as desired in the weeks leading up to surgery and afterward. All participants will complete questionnaires while waiting in their private preoperative rooms on the day of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
The investigator enrolling patients will be blinded to group assignments when recruiting patients (until families have consented to participate).
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients ages 5-13 years (inclusive) scheduled for a tonsillectomy, along with their caregivers.
排除标准
- •Patients/caregivers who do not speak English and/or Spanish, do not have a mobile device, or are unable to give consent and assent.
研究组 & 干预措施
Control
Families will receive standard care (standard educational handouts and preoperative consults).
Intervention
Patients and caregivers will use the "Ready for Tonsillectomy" mobile application on their mobile devices as they prepare for and recover from surgery, in addition to standard care. Individual families will receive a phone call for enrollment/verbal informed consent at least 2 weeks before the scheduled surgery, likely around the time of the clinic visit when surgery is scheduled. Participants assigned to the intervention arm will download the mobile application at this time. They will be able to access the application as often as desired in the weeks leading up to surgery and afterward.
干预措施: "Ready for Tonsillectomy" educational mobile application (Behavioral)
结局指标
主要结局
Children's Perioperative Multidimensional Anxiety Scale (CPMAS)
时间窗: Preoperative period, day of surgery
The Children's Perioperative Multidimensional Anxiety Scale (CPMAS) is a patient-reported, 5-item visual analog scale validated for patients 7-13 years of age. The scale has demonstrated good internal consistency and test-retest reliability, and it is more feasible to implement than an observer-rated metric. Scores range from 0-500; higher scores indicate greater anxiety (worse outcomes).
次要结局
- Patients' confidence and coping(Preoperative period, day of surgery)
- State-trait Anxiety Inventory (STAI)(Preoperative period, day of surgery)
- User analytics(Throughout the study period (beginning with time of download))
- Face, Legs, Activity, Cry, Consolability (FLACC) scale(Postoperative recovery, day of surgery)
- Caregivers' satisfaction and self-efficacy(Preoperative period, day of surgery)
- Children's Fear Scale (CFS)(Preoperative period, day of surgery)
- Caregiver-initiated postoperative call volumes(Up to 2 weeks after surgery)