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Clinical Trials/NCT04300283
NCT04300283
Completed
Not Applicable

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 site in 1 country14 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Surgery
Sponsor
Oslo University Hospital
Enrollment
14
Locations
1
Primary Endpoint
Patient experiences of the intervention
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Silje Endresen Reme

Professor

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Patient experiences of the intervention

Time Frame: 1 week post-surgery

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

Secondary Outcomes

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

Study Sites (1)

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