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Completed

NCT Number: NCT04300283

Pre-operative Hypnosis to Prevent Side Effects After 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.

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Key information

Conditions

Breast Cancer Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypnosis

Behavioral

See previous description

Primary outcomes

  1. 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

  1. 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

  2. Fatigue severity one week after surgery

    Time frame: 1 week post-surgery

    Numeric Rating Scale of fatigue severity

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Acronym: PREVENTpilot

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2020
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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