NCT04129333

Brief Summary

Procedural pain in resuscitation is common in the conscious patient. However, analgesia and sedation may be impossible because of the acute pathology leading to resuscitation, comorbidities or the urgency of the invasive procedure. In addition, the use of analgesics and sedatives is responsible for adverse effects. In this context, hypnosis appears to be an additional analgesic tool that would reduce the consumption of analgesics and sedatives and thus reduce their side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 30, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

2.1 years

First QC Date

October 14, 2019

Last Update Submit

November 8, 2022

Conditions

Invasive Procedure

Outcome Measures

Primary Outcomes (1)

  • Pain assessment

    Oral assessment scale (0 : no pain - 10 : maximal pain)

    Immediately after the end of the invasive procedure (Hour 0)

Secondary Outcomes (11)

  • Pain assessment

    The first hour after the end of the procedure (Hour 1)

  • Morphine equivalent dose

    Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)

  • Sedatives dose

    Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)

  • Local Anesthesia dose

    Immediately after the end of the invasive procedure (Hour 0)

  • Comfort scale

    Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)

  • +6 more secondary outcomes

Study Arms (2)

Hypnosis group

EXPERIMENTAL

A hypnosis group with standard care during the invasive procedure according to the usual practice of the care team and setting up a hypnotic accompaniment by an nurse trained beforehand and dedicated throughout the gesture. The hypnosis session will end at the same time as the invasive procedure.

Other: Hypnosis

Control group

PLACEBO COMPARATOR

A control group with standard care during the invasive procedure according to the usual practice of the care team.

Other: No hypnosis

Interventions

HypnosisOTHER

The hypnosis session : * Creation of the therapist-patient link * Choice of a theme and the preferred sensory channel by the patient * Collection of the theme chosen by the patient * Orientation in the here and now. * Induction * Realization of the gesture and hypnosis * At the end of the procedure, reassociation of the patient in the here and now

Hypnosis group
No hypnosisOTHER

No hypnosis

Control group

Eligibility Criteria

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

You may qualify if:

  • Major patient admitted to intensive care
  • Glasgow score = 15
  • Necessity during the stay of making an invasive gesture among:
  • Thoracic drainage
  • Placement of a central venous catheter or a Swan-Ganz catheter
  • Establishment of a dialysis catheter
  • Introduction of an invasive arterial catheter
  • Patient giving free, informed and written consent
  • Patient affiliated to a social security scheme
  • Procedure to be carried out in extreme urgency
  • Confusional state making hypnosis impossible, evaluated by CAM-ICU (Confusion Assessment Method for the Intensive Care Unit)
  • Decompensated psychiatric illness
  • Patient sedated or intravenous analgesia continued at the time of the procedure
  • Patient intubated
  • Patient with a contraindication to sedation or analgesia at the time of the procedure
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint-Brieuc Hospital

Saint-Brieuc, Brittany Region, 22000, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

Related Publications (1)

  • Maamar A, Faleur C, Pedrono K, Adeux MP, Anne M, Verdes A, Fillatre P, Debarre M, Mercier N, Revest M, Massart N, Poilvet N, Terzi N, Tadie JM, Gacouin A, Laviolle B. Hypnosis for unplanned procedural pain in the intensive care unit: the HYPIC randomized clinical trial. Crit Care. 2025 Jul 18;29(1):312. doi: 10.1186/s13054-025-05563-9.

    PMID: 40682163DERIVED

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Multicenter prospective national, controlled, randomized, superiority study, open-label with blind evaluation, on 2 parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 16, 2019

Study Start

December 30, 2019

Primary Completion

January 25, 2022

Study Completion

October 11, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)