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临床试验/NCT04300283
NCT04300283已完成不适用

A Pilot Study Investigating the Feasibility of a Pre-operative Hypnosis Intervention to Prevent Post-operative Pain After Thoracic and Breast Cancer Surgery

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年5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
14
试验地点
1
主要终点
Patient experiences of the intervention

研究概览

简要总结

The aim of the pilot study is to translate and feasibility test a brief hypnosis intervention in 8-10 patients that are about to undergo thoracic surgery and in 4-5 patients about to undergo breast cancer surgery.

详细描述

The hypnosis intervention will be based on a protocol from Montgomery et al. They showed in a recent study that a brief 15-minute hypnosis intervention was effective in reducing a number of common side effects, including pain, fatigue and nausea. The scripted session includes a relaxation-based induction, suggestions for pleasant visual imagery, suggestions to experience relaxation and peace, and specific symptom-focused suggestions. The intervention will be professionally translated into Norwegian, and adapted and modified as necessary to the specific context of this study. The PI, who is a an experienced clinical psychologist, will hold the session in the pilot study. Patients will further be instructed to use hypnosis on their own following the intervention session.

The patients will further be invited to participate in semi-structured interviews upon completion of the intervention, either by phone or in person, to discuss their experiences with the intervention, and share any advice for modifications or changes to the interventions or procedures. Systematic text condensation will be applied in the analyses of the interviews.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients about to undergo either breast cancer surgery or thoracic surgery

排除标准

  • Insufficient Norwegian speaking or writing skills to participate in the intervention
  • cognitive and psychiatric impairment
  • other serious malignancies

结局指标

主要结局

Patient experiences of the intervention

时间窗: 1 week post-surgery

Obtained through qualitative interviews to assess patient experiences and possibly adverse effects of the intervention

次要结局

  • Fatigue severity one week after surgery(1 week post-surgery)
  • NRS Pain intensity one week after surgery(1 week post-surgery)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silje Endresen Reme

Professor

Oslo University Hospital

研究点 (1)

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