The Effectiveness of Clinical Hypnotherapy in Reducing Anxiety and Pain in Major Surgical Procedures (Nuss and Scoliosis Repair)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pre-operative anxiety
研究概览
简要总结
The purpose of this randomized controlled study is to test the feasibility of clinical hypnotherapy as a perioperative intervention for the reduction of pre-operative anxiety, post-operative pain, and other-related symptoms (nausea, vomiting, spasms, length of stay, self mastery) in children undergoing scoliosis repair or Nuss procedure.
详细描述
Participants will be 60 children, aged 10-21, ASA 1 and 2 Classification, with idiopathic scoliosis or congenital deformity of the chest wall, who are undergoing Nuss procedure/scoliosis repair at the Nationwide Children's hospital. The design of this study is a single-blinded randomized controlled trial-comparing pre-operative anxiety, post-operative pain and other related symptoms in two groups of:
Group 1: Receives hypnosis (described below) Plus PCA Group 2: Standard of care (PCA)
Interventions:
Group I) Hypnosis: The hypnosis group will receive a semi-structured intervention by primary investigator. The intervention is somewhat individualized based on the recipients personal characteristics (e.g., age, gender, medical history). The intervention will begin with an "induction" phase during which the participant is guided to relax and to focus their attention on one stimuli. The intervention will then proceed with a "suggestion" phase. Suggestions used in this phase will all be directed toward decreasing the patient's anxiety and post-operative pain. Patients will be taught self-hypnosis to decrease distress and reframe painful experiences.
Group II) Control: This group will receive the standard of care of Nationwide Children's hospital.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose health status is American Society of Anesthesiologists (ASA) physical status I to II, aged 10-21, with idiopathic scoliosis or congenital deformity of the chest wall, who are undergoing Nuss procedure/scoliosis repair at the Nationwide Children's hospital.
- •Parents/Guardian willing and able to authorize informed consent
- •Patients willing and able to authorize assent
排除标准
- •ASA classification III, IV (children with a chronic or severe disease).
- •Children with neuromuscular disorders
- •Children with developmental delay
- •Patients with preexisting mental illness
结局指标
主要结局
Pre-operative anxiety
时间窗: Day of surgery, just prior to the procedure
The STAI, completed by the patient to chart their own anxiety level, is a 40-item self-report measure that contains 20 items measuring state anxiety and 20 items measuring trait anxiety. Subjects are asked to respond on a 4-point Likert scale. Total scores for state and trait portions separately range from 20 to 80, with higher scores denoting higher levels of anxiety.
Post-operative pain
时间窗: 24 hours post-op
Total opiate consumption in the first 24 hours will be recorded.
次要结局
未报告次要终点
研究者
Haleh Saadat
Director of Complementary and Alternative Medicine
Nationwide Children's Hospital