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Completed

NCT Number: NCT04399850

Impact of Hypnosis During Invasive Procedure in Intensive Care Unit

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint-Louis

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypnosis group

Other

Patients who receive hypnosis

Primary outcomes

  1. Pain distress

    Time frame: within 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 outcomes

  1. Pain intensity

    Time frame: within 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).

  2. Number of adverse events

    Time frame: during procedure

  3. Length of each painful procedure

    Time frame: up to 3 months

  4. Analgesia dose

    Time frame: within first and 24 hours after procedure

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

  5. Type of analgesia

    Time frame: within first and 24 hours after procedure

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

  6. Anxiety

    Time frame: within 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).

  7. Hospital Anxiety and Depression (HAD) scale

    Time frame: at 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.

  8. Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)

    Time frame: 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)

  9. Proportion of patients who had hypnosis transe

    Time frame: during procedure

  10. Description of the experience of hypnosis

    Time frame: at 3 months

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: HYPNOICU

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 22, 2020
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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