NCT02818101

Brief Summary

The purpose of this study is to confirm the utility for hypnosis in the coronary angiographic examination. The technique would be an alternative to prevent the consumption of anesthesic drugs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 9, 2019

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

March 30, 2016

Last Update Submit

July 8, 2019

Conditions

Coronary Angiography

Outcome Measures

Primary Outcomes (1)

  • State Anxiety

    Spielberger State-Trait Anxiety Inventory (STAI):

    1 day

Secondary Outcomes (6)

  • Comfort for the operator of the angiography

    1 day

  • Pain

    1 day

  • Heart rate

    1 day

  • Blood pressure

    1 day

  • Major complications

    1 day

  • +1 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

No hypnosis session before the coronary angiography

Hypnotised group

EXPERIMENTAL

Hypnosis session before the coronary angiography

Behavioral: Hypnosis session

Interventions

Hypnosis sessionBEHAVIORAL
Hypnotised group

Eligibility Criteria

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

You may qualify if:

  • adult
  • coronary angiography scheduled with or without stenting
  • registered with a social security scheme
  • people informed clearly by the investigator

You may not qualify if:

  • coronary angiography already performed
  • not well french speaking and understanding
  • with functional disabilities (mental disorder, ...)
  • known background of schizophrenia
  • deaf or hard of hearing
  • patient under legally protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chr Metz Thionville

Metz, 57085, France

Location

Related Publications (1)

  • Abensur Vuillaume L, Gentilhomme C, Weber S, Ouamara N, Bayard J, Valla M, Khalife K, Goetz C, Guler N. Effectiveness of Hypnosis for the Prevention of Anxiety During Coronary Angiography (HYPCOR study): a prospective randomized study. BMC Complement Med Ther. 2022 Nov 29;22(1):315. doi: 10.1186/s12906-022-03792-x.

    PMID: 36447198DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

June 29, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2017

Study Completion

May 1, 2018

Last Updated

July 9, 2019

Record last verified: 2016-03

Locations

FR(1)