Impact of Hypnosis During Invasive Procedure in Intensive Care Unit
HYPNOICU
1 other identifier
interventional
124
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Sep 2020
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedStudy Start
First participant enrolled
September 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2024
CompletedJuly 17, 2024
July 1, 2024
3.5 years
April 29, 2020
July 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Pain intensity
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
within first and 24 hours after procedure
Type of analgesia
within first and 24 hours after procedure
- +5 more secondary outcomes
Study Arms (2)
Patients who receive hypnosis
EXPERIMENTALPatients who receive hypnosis during procedure by experiment physician
Control arm
NO INTERVENTIONPatient with conventional pain management
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Saint-Louis
Paris, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2020
First Posted
May 22, 2020
Study Start
September 28, 2020
Primary Completion
March 28, 2024
Study Completion
March 28, 2024
Last Updated
July 17, 2024
Record last verified: 2024-07