ERAS in Pediatric and Adolescent Gynecology: How Important is Preoperative Counseling in Patient Outcomes and Does Parent Versus Patient Counseling Impact Success?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Numeric Pain rating scores at post-op days 1 and 7
研究概览
简要总结
The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.
详细描述
Enhanced Recovery After Surgery (ERAS) protocols have been shown to be safe and effective in pediatric and adolescent gynecology (PAG) participants. However, the individual elements of ERAS that are associated with positive outcomes have not been identified. Pre-operative counseling and education is a standard component of ERAS. In pediatric and adolescent gynecology (PAG), pre-operative counseling is typically administered to the participant's caregiver rather than directly to the participant. It is possible that direct participant involvement in ERAS pre-operative counseling could be an important factor to improve post-surgical outcomes. To investigator's knowledge, no studies have examined the impact of direct participant involvement in pre-operative counseling on ERAS outcomes in the PAG population.
The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •9- 17 years of age
- •Patient is undergoing abdominal surgery and being managed under the ERAS protocol
排除标准
- •Developmental delay (IQ < 70) determined by documentation in medical record
- •Emergency or non-elective surgical cases
- •Patients who attend clinic appointments independently from their caregiver
研究组 & 干预措施
pre-operative counseling with their caregiver
Patients will be asked to attend a standard-of-care pre-operative teaching session with their parent.
干预措施: Enhanced Recovery After Surgery (ERAS) Counseling to Patients (Other)
caregiver-only counseling.
Parents-only will attend a standard-of-care pre-operative teaching session.
干预措施: Enhanced Recovery After Surgery (ERAS) Counseling to Caregiver (Other)
结局指标
主要结局
Numeric Pain rating scores at post-op days 1 and 7
时间窗: 1-7 days after surgery
Minimum value = 0, maximum value = 10. 0 = no pain at all, 10 = worst pain imaginable. A higher score on the rating scale indicates a worse outcome.
次要结局
- Rate of medication adherence to ERAS-prescribed medications(1-7 days after surgery)
- Number of participants who have returned to school at 7-days post-op(7 days after surgery)
- Rate of narcotic medication prescriptions(1-7 days after surgery)