iPAWS: Improving Pain Management After Wisdom Tooth Extraction Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants who complete the active treatment phase (feasibility)
研究概览
简要总结
This is a clinical trial that will evaluate the feasibility and acceptability of a virtual brief program for adolescents and young adults undergoing wisdom tooth extraction and their parents. The program aims to teach youth safe and effective ways to manage post-surgical pain as well as decrease risky health behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 15 to 20 years
- •Undergoing wisdom tooth extraction for the first time
- •Able to read simple English
- •*Endorse cannabis use at least two days per week on average in the past 28 days
- •*The investigator aims to recruit at least 50 participants who are using cannabis at least two days per week in the past 28 days on average and will recruit up to 100 additional participants who use other substances, use cannabis at a lesser intensity, or do not use any substances.
- •(Parent/Guardian only) - Have a child who is undergoing wisdom tooth surgery and is participating in the study
排除标准
- 未提供
结局指标
主要结局
Number of participants who complete the active treatment phase (feasibility)
时间窗: End of active treatment phase (6 weeks)
The number of participants who complete the active treatment phase will determine feasibility. The treatment will be considered feasible if the number of participants who complete treatment is ≥ 70%.
Number of participants who rate their treatment experience in the "satisfactory" or "highly satisfactory" range on the Client Satisfaction Questionnaire (Acceptability)
时间窗: End of active treatment phase (6 weeks)
The Client Satisfaction Questionnaire (CSQ-8) which ranges in scores from 8 to 32 will determine acceptability. Higher scores indicate higher satisfaction (i.e. better outcomes). Treatment will be considered acceptable if the number and percentage of participants who rate their experience either "satisfactory" or "highly satisfactory is ≥ 80%.
次要结局
- Number of cannabis use days(Last 3 weeks of active treatment phase (weeks 4-6))
- Pain intensity(Last 3 weeks of active treatment phase (weeks 4-6))
- Substance use craving(Last 3 weeks of active treatment phase (weeks 4-6))
- Abstinent days(Last 3 weeks of active treatment phase (weeks 4-6))
- Pain intereference(Last 3 weeks of active treatment phase (weeks 4-6))
- Pain coping strategies(Last 3 weeks of active treatment phase (weeks 4-6))