Integration of Self-Hypnosis in an Enhanced Recovery After Surgery (ERAS) Program: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Feasibility of participating in pre-operative self-hypnosis
研究概览
简要总结
This trial studies how well self-hypnosis works in enhancing recovery after surgery in patients with gynecologic cancer. A guided relaxation method called self-hypnosis may help affect how patients feel pain and symptoms after surgery.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate whether participation in pre-operative self-hypnosis (SH) is feasible and will improve patients' perception of post-surgical pain, after undergoing open gynecologic surgery (laparotomy) on an enhanced recovery pathway.
SECONDARY OBJECTIVES:
I. To evaluate whether participation in pre-operative SH is associated with changes in use of opioid medication, including time to first postoperative opioid and total dose of opioids taken (converted to morphine equivalents) and avoidance of opioids.
II. To explore whether participation in pre-operative SH is associated with changes in length of stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
- •Planned participation in the Gynecologic Enhanced Recovery Pathway
- •Patient must be able to read, understand, and speak English
- •Consents to being part of a randomized study
- •Patient has physical and mental capabilities to take part in study
排除标准
- •Sensitivity to amide-type local anesthetics
- •Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days
- •Emergency surgery of any type that does not allow for proper time for protocol review by the patient
- •Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
- •Patients undergoing known/anticipated anterior abdominal wall hernia repairs
- •Patients undergoing pelvic exenteration
- •Patients with known major psychiatric disease
- •Patients with hearing impairment such that they are unable to hear the intervention
研究组 & 干预措施
Arm I (usual care)
Patients receive usual care including receipt of multi-modal analgesia and the injection of a local analgesic at the time of surgery on the ERAS pathway.
干预措施: Best Practice (Other)
Arm I (usual care)
Patients receive usual care including receipt of multi-modal analgesia and the injection of a local analgesic at the time of surgery on the ERAS pathway.
干预措施: Quality-of-Life Assessment (Other)
Arm I (usual care)
Patients receive usual care including receipt of multi-modal analgesia and the injection of a local analgesic at the time of surgery on the ERAS pathway.
干预措施: Questionnaire Administration (Other)
Arm II (usual care, self-hypnosis guided relaxation)
Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway.
干预措施: Best Practice (Other)
Arm II (usual care, self-hypnosis guided relaxation)
Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway.
干预措施: Hypnotherapy (Procedure)
Arm II (usual care, self-hypnosis guided relaxation)
Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway.
干预措施: Quality-of-Life Assessment (Other)
Arm II (usual care, self-hypnosis guided relaxation)
Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Feasibility of participating in pre-operative self-hypnosis
时间窗: Up to 1 day
Will assess proportion of participants who listen to the complete audio file in the preoperative holding area.
Patients' perception of post-surgical pain
时间窗: Post-operative day 1 (POD1)
Will summarize POD1 pain scores for each treatment arm using descriptive statistics. Will use a Wilcoxon rank sums test to determine if the POD1 pain scores in the self-hypnosis arm are lower than the usual care arm. Pain intensity score from 0 to 10.
次要结局
未报告次要终点