Pre-operative Hypnosis to Prevent Side Effects After Surgery (PREVENTpilot)

June 8, 2021 updated by: Silje Endresen Reme, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pre-operative hypnosis
Behavioral: Hypnosis
See previous description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS Pain intensity one week after surgery
Time Frame: 1 week post-surgery
Numeric Rating Scale (0-10) of pain intensity in the surgical and referred area
1 week post-surgery
Fatigue severity one week after surgery
Time Frame: 1 week post-surgery
Numeric Rating Scale of fatigue severity
1 week post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Silje E Reme, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2018

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (ACTUAL)

March 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/781

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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