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Impact of Hypnosis During Invasive Procedure in Intensive Care Unit

Not Applicable
Completed
Conditions
Pain
Interventions
Other: Hypnosis group
Registration Number
NCT04399850
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
124
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Patients who receive hypnosisHypnosis groupPatients who receive hypnosis during procedure by experiment physician
Primary Outcome Measures
NameTimeMethod
Pain distresswithin the before and the first hour after the procedure

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).

Secondary Outcome Measures
NameTimeMethod
Number of adverse eventsduring procedure
Analgesia dosewithin first and 24 hours after procedure

The dose of each analgesia treatment received by the patient will be collected.

Hospital Anxiety and Depression (HAD) scaleat 3 months

The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic.

HAD scale 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.

Proportion of patients who had hypnosis transeduring procedure
Pain intensitywithin first hour and first 24 hours after procedure

Pain intensity will be assessed using Numeric rating scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).

Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)at 3 months

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)

Anxietywithin first and 24 hours after procedure

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).

Length of each painful procedureup to 3 months
Type of analgesiawithin first and 24 hours after procedure

The type of each analgesia treatment received by the patient will be collected.

Description of the experience of hypnosisat 3 months

Qualitative analysis of the experience of hypnosis will be performed using the semi-structured interview

Trial Locations

Locations (1)

Hôpital Saint-Louis

🇫🇷

Paris, France

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