Impact of Hypnosis During Invasive Procedure in Intensive Care Unit

Assistance Publique - Hôpitaux de Paris124 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

124

Conditions

Pain

Interventions

Hypnosis groupOTHER

Patients who receive hypnosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Saint-Louis

Paris, France

Outcomes

Primary Outcomes

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).

Time frame: within the before and the first hour after the procedure

Secondary Outcomes

Pain intensity

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

Time frame: within first hour and first 24 hours after procedure

Number of adverse events

Time frame: during procedure

Length of each painful procedure

Time frame: up to 3 months

Analgesia dose

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

Time frame: within first and 24 hours after procedure

Type of analgesia

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

Time frame: 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).

Time frame: within first and 24 hours after procedure

Hospital Anxiety and Depression (HAD) 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. 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.