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临床试验/NCT04645654
NCT04645654已完成不适用

A Randomized-controlled Clinical Trial of Brief Postoperative Hypnosis Intervention as Multimodal Analgesia After Major Abdominal Surgery in the ERAS Protocol

University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
176
试验地点
2
主要终点
Pain intensity at mobilisation

研究概览

简要总结

This study will measure the efficacy of hypnosis on pain after a major abdominal surgery. The aim is to further improve comfort and rehabilitation of patients after surgery, beyond the usual early recovery after surgery (ERAS) enhancement protocols.

Patients will be randomised (1:2) to the standard of care regarding pain management and rehabilitation, as part of the ERAS protocol, vs. ERAS + an additional hypnosis intervention. In this group, hospitalised patients are given 3 hypnosis sessions targeting analgesia between postoperative day 1 to 12.

The study will collect outcomes about pain and its burden, sleep quality, appetite, mobilisation and mood. Secondary outcomes also include use of pain medication and length of hospital stay.

详细描述

The primary objective of the present study is to evaluate the efficacy of hypnosis as an adjunct to the standard of care pain management program on postoperative pain compared to the standard ERAS program. Our hypothesis is that hypnosis, as part of a multi-modal analgesic management plan, will lead to decreased levels of pain compared to standard of care.

A secondary hypothesis is that better controlled pain will lead to enhanced recovery, in terms of post-operative incidence of complications, physical comfort and independence, psychological and emotional state and length of stay.

This study is an open label randomized controlled trial with two arms, comparing hypnosis as adjunctive therapy vs. standard of care. It is a monocentric study and will take place at Centre Hospitalier Universitaire Vaudois (CHUV), a teaching hospital in Lausanne, Switzerland. It represents a collaboration between the Service of Visceral Surgery and the Center of Integrative and Complementary Medicine.

Participants will be recruited before a planned surgery, as well as in the post-surgical setting. They will be screened by the study team to ensure they fulfil the inclusion criteria. If eligible and after informed consent is obtained, an assessment of the cognitive function will be performed (cf. Chapter 4: study population). All included participants will then be randomized in a 2:1 proportion to the "Hypnosis (H)" group or the "Standard of Care (SOC)" group.

After major abdominal surgery, all participants will benefit from a standard ERAS recovery program. The ERAS protocol involves multimodal pain management with medications, interventional pain therapy as needed, and psychological support if needed.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Female and male adults (from 18 years old).
  • Major abdominal surgery with planned hospitalisation of more than seven days post-operatively, according to clinician's evaluation
  • Able to give informed consent as documented by signature
  • Interested in trying hypnosis as a complementary pain management therapy

排除标准

  • Inability to engage in the intervention of the study, e.g. inability to communicate in French without a translator, cognitive impairment, severe hearing impairment
  • Acute psychiatric (e.g. psychotic or suicidal ideation) or somatic (e.g. unstable cardio-respiratory condition) co-morbidity preventing full engagement during intervention.

结局指标

主要结局

Pain intensity at mobilisation

时间窗: Between postoperative day 1 to 12.

visual analogue pain intensity scale from 0 (no pain) to 10 (most intense pain imaginable)

次要结局

  • Pain intensity at rest(Between postoperative day 1 to 12.)
  • Pain unpleasantness(Between postoperative day 1 to 12.)
  • Opioid consumption(Between postoperative day 1 to 12)
  • Length of hospital stay(through study completion; records checked up to 100 days after end of study participation)
  • Post-surgical complications(Between postoperative day 1 to 12)

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chantal Berna

Professor

University of Lausanne Hospitals

研究点 (2)

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