CTRI/2019/04/018811尚未招募Phase 3 4
Hypnosis as a tool for reducing pre-operative anxiety in patients undergoing total knee replacement – a randomized case control study.
Yamini Arora1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2019年4月30日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Effect of pre-operative use of clinical hypnosis on pre-operative anxiety scores
研究概览
简要总结
Clinical hypnosis has been shown to reduce preoperative anxiety and improve postoperative pain scores in the patient undergoing both minor and major surgical procedures. Role of clinical hypnosis in the Indian population and Joint replacement patients, however, remains unevaluated. In this study, we wish to evaluate the efficacy of clinical hypnosis in reducing preoperative anxiety in patients undergoing knee replacement surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 30 to 75 years 2.Patients with ASA grade I & II 3.Body Mass Index( BMI) less than 40kg/m2 4.Able to understand and cooperate 5.Willing to participate 6.Patients scheduled for Knee Replacement under regional anesthesia.
排除标准
- •1.Patient refusal 2.ASA grade III and IV 3.Patients with history of opioid intake or/and substance abuse 4.Difficulty in hearing and following instruction.
- •5.Patients with history of disorder of cognition or psychiatric disorder 6.Patients done under general anesthesia 7.Use of epidural catheter.
- •8.Patients with BMI greater than 40 kg/m2 9.Patients having allergy to any drug used as a part of the protocol 10.Patients with past history of any surgery or use of hypnosis.
结局指标
主要结局
Effect of pre-operative use of clinical hypnosis on pre-operative anxiety scores
时间窗: Anxiety levels on arrival to the pre operative area.
次要结局
- Compare the pre-operative anxiety scores of the patients comprising the study group with those receiving the standard of care therapy(Compare the incidence of post-operative nausea and analgesic drug requirement between the two groups.)
研究者
研究点 (1)
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