Pre-operative Hypnosis to Prevent Side Effects After Surgery

Breast Cancer Surgery Clinical Trial

— PREVENTpilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300283
• Other study ID #: 2018/781
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Surgery
• Breast Neoplasms

Intervention

Behavioral:
• Hypnosis
See previous description

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient experiences of the intervention	Obtained through qualitative interviews to assess patient experiences and possibly adverse effects of the intervention	1 week post-surgery
Secondary	NRS Pain intensity one week after surgery	Numeric Rating Scale (0-10) of pain intensity in the surgical and referred area	1 week post-surgery
Secondary	Fatigue severity one week after surgery	Numeric Rating Scale of fatigue severity	1 week post-surgery