Impact of Hypnosis During Invasive Procedure in Intensive Care Unit

NCT ID: NCT04399850

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-28

Study Completion Date

2024-03-28

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Patients who receive hypnosis

Patients who receive hypnosis during procedure by experiment physician

Group Type EXPERIMENTAL

Hypnosis group

Intervention Type OTHER

Patients who receive hypnosis

Control arm

Patient with conventional pain management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hypnosis group

Patients who receive hypnosis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Saint-Louis

Paris, , France

Site Status

Countries

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France

Other Identifiers

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APHP191042

Identifier Type: -

Identifier Source: org_study_id

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