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Completed

NCT Number: NCT04129333

HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

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.

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Key information

Conditions

Invasive Procedure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint-Brieuc Hospital, Saint-Brieuc, Brittany Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Non inclusion Criteria:

  • 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
  • Patient receiving topical anesthesia before the start of the procedure
  • Major person subject to legal protection (court bail, curator, guardianship) or deprived of liberty
  • Patient already included in the study during the completion of a previous invasive procedure
  • Patient participating in a research involving an interventional human person (category 1) on an analgesic / sedative drug

Treatment and study plan

Hypnosis

Other

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

No hypnosis

Other

No hypnosis

Primary outcomes

  1. Pain assessment

    Time frame: Immediately after the end of the invasive procedure (Hour 0)

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

Secondary outcomes

  1. Pain assessment

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

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

  2. Morphine equivalent dose

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

    Cumulative use of morphine-morphine analgesics in morphine equivalent during the procedure and the first hour after the end of the procedure (H1)

  3. Sedatives dose

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

    Cumulative use of sedatives during the procedure and the first hour after the end of the procedure (H1)

  4. Local Anesthesia dose

    Time frame: Immediately after the end of the invasive procedure (Hour 0)

    Consumption of local anesthesia during the invasive procedure

  5. Comfort scale

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

    Comfort measured by the numerical comfort scale (0 no comfort - 10 most comfortable situation imaginable)

  6. Anxiety

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

    Patient anxiety measured by the numerical anxiety scale (0 no anxiety - 10 greatest anxiety imaginable) .

  7. Duration

    Time frame: Immediately after the end of the invasive procedure (Hour 0)

    Duration of the invasive procedure including the period of hypnosis

  8. Number of attempts and failures of the procedure

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

    Number of attempts and failures of the procedure

  9. Adverse events

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

    Number of adverse events occurring during the procedure (hematoma, failure to pose, ...)

  10. Nurse stress

    Time frame: Immediately after the end of the invasive procedure (Hour 0)

    Stress of the nurse in charge of the patient quantified by a numerical scale of evaluation (0 no stress - 10 greatest stress imaginable)

  11. Length of stay in intensive care unit

    Time frame: Day 28

    Length of stay in intensive care unit, measured until D28

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: HYPIC

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 16, 2019
Registry last updated
Nov 9, 2022

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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