A Pilot Study of the Effectiveness of Complementary Therapies to Reduce Pain in Spinal Fusion Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Postoperative Pain (Total Opioid Use)
研究概览
简要总结
In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing touch as adjunct therapies to the standard of care, will improve analgesic use for post operative pain. In this pilot study the investigators will randomize 30 adolescents undergoing spinal fusion for idiopathic scoliosis to two test groups: Hypnosis with Pain Management Standard of Care for Post Op Pain, Healing Touch with Pain Management Standard of Care, and a control group (Pain Management Standard of Care only).
详细描述
Female adolescents with the diagnosis of idiopathic scoliosis requiring surgery will be approached by a member of the research team at the pre-surgical evaluation visit to participate in the study. Randomization will be done at the time of the pre-surgical visit. Microsoft Excel will be used to generate a random group assignment table to one of the following groups:
CONTROL GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion Surgery
HYPNOSIS GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion and Hypnosis intervention consisting of induction to achieve a state of focused attention with heightened receptivity for acceptable suggestions targeting relaxation, comfort and healing.
HEALING TOUCH GROUP: Standard Pain Management for Idiopathic Posterior Spinal Fusion Surgery and Healing Touch intervention (Chakra Connection, Magnetic Clearing)
Protocol:
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
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females, ages 12 - 17
- •Diagnosis of idiopathic scoliosis
排除标准
- •Patients with chronic or severe disease conditions requiring spinal fusion surgery.
- •Children with profound mental disabilities or developmental delay not allowing them to voluntarily assent to participate.
结局指标
主要结局
Postoperative Pain (Total Opioid Use)
时间窗: up to postoperative day 4
Total Opioid use will be measured in mg/kg/hour daily until discharge, and at postoperative follow-up visit. Postoperative time in PACU starts on admission to PACU until discharged to general nursing care floors. Postoperative Day #0 (POD #0) start on the day of surgery from the time the patient is discharged from the PACU to 7:00 AM the following morning. POD #1 is from 07:00 the day after surgery to the following morning (24 hour period) at 07:00. POD #2, POD #3 are the following 24 hour periods until time of discharge. The first outpatient postoperative appointment was four weeks after surgery.
次要结局
- Cortisol Level(up to 4-week postoperatively)
- Pain Score(up to postoperative day 4)
- Child Pain Anxiety Symptoms Scale (CPASS)(up to 4 weeks postoperatively)
研究者
Karen Sacks
MSN, PNP
Nemours Children's Clinic