NCT04300283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

2.7 years

First QC Date

January 29, 2020

Last Update Submit

June 8, 2021

Conditions

Breast Cancer Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • NRS Pain intensity one week after surgery

    1 week post-surgery

  • Fatigue severity one week after surgery

    1 week post-surgery

Study Arms (1)

Pre-operative hypnosis

EXPERIMENTAL
Behavioral: Hypnosis

Interventions

HypnosisBEHAVIORAL

See previous description

Pre-operative hypnosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

  • 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.

    PMID: 34818921DERIVED

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Silje E Reme, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Pilot testing of a pre-operative hypnosis intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2020

First Posted

March 9, 2020

Study Start

May 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)