Impact of Hypnosis During Invasive Procedure in Intensive Care Unit (HYPNOICU)

Pain during ICU stay remains one of the major complaints for patients. Beside pain intensity, well described by patients' self reports, pain distress, which is an emotional experience, cannot be treated with usual analgesia. The aim of the study is to analyze the impact of hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU patients.

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Other: Hypnosis group

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthieu RESCHE-RIGON; Phone Number: 0142499742 0142499742; Email: matthieu.resche-rigon@univ-paris-diderot.fr
• Study Contact Backup: Name: Virginie Lemiale; Phone Number: +331 42 49 94 19; Email: virgnie.lemiale@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Hôpital Saint-Louis
    • Contact: Virginie Lemiale; Phone Number: +331 42 49 94 19

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients aged 18 years and older
• ICU hospitalisation
• Non-sedated patients who need an invasive procedure (Invasive procedures are defined as chest tube (insert or remove), fibroscopy, catheter insert, lumbar punction and bone marrow aspiration)
• Physician experienced in hypnosis available
• written informed consent
• health insurance

Exclusion Criteria:

• sedation and intubation, delirium, end-of-life decision,
• deaf patient,
• patient who does not understand French language,
• pregnancy
• patient under guardianship or curatorship
• lack of health insurance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients who receive hypnosis; Patients who receive hypnosis during procedure by experiment physician	Other: Hypnosis group; Patients who receive hypnosis
No Intervention: Control arm; Patient with conventional pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain distress	Pain distress change in the hypnosis group measured before and within the first hour after the procedure. Pain distress will be assessed using Numeric rating scale, which goes from 0 (no pain stress) to 10 (maximum pain stress).	within the before and the first hour after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be assessed using Numeric rating scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).	within first hour and first 24 hours after procedure
Number of adverse events		during procedure
Length of each painful procedure		up to 3 months
Analgesia dose	The dose of each analgesia treatment received by the patient will be collected.	within first and 24 hours after procedure
Type of analgesia	The type of each analgesia treatment received by the patient will be collected.	within first and 24 hours after procedure
Anxiety	Anxiety within first and 24 hours after procedure will be assessed using Numeric rating scale, which goes from 0 (no anxiety) to 10 (maximum anxiety imaginable).	within first and 24 hours after procedure
Hospital Anxiety and Depression scale	The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). A higher score indicates worse outcome.	at 3 months
Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)	The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 to 4 . The IES-R yields a total score (ranging from 0 to 88)	at 3 months
Proportion of patients who had hypnosis transe		during procedure
Description of the experience of hypnosis	Qualitative analysis of the experience of hypnosis will be performed using the semi-structured interview	at 3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Anticipated): September 28, 2021
• Study Completion (Anticipated): December 18, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: hypnosis; pain distress; invasive procedure
• Other Study ID Numbers: APHP191042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No