Pre-operative Hypnosis to Prevent Side Effects After Surgery

NCT ID: NCT04300283

Last Updated: 2021-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot testing of a pre-operative hypnosis intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pre-operative hypnosis

Group Type EXPERIMENTAL

Hypnosis

Intervention Type BEHAVIORAL

See previous description

Interventions

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Hypnosis

See previous description

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Silje Endresen Reme

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Silje E Reme, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Lind SB, Jacobsen HB, Solbakken OA, Reme SE. Clinical Hypnosis in Medical Care: A Mixed-Method Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211058678. doi: 10.1177/15347354211058678.

Reference Type DERIVED
PMID: 34818921 (View on PubMed)

Other Identifiers

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2018/781

Identifier Type: -

Identifier Source: org_study_id

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