Impact of Hypnosis During Invasive Procedure in Intensive Care Unit

Pain Clinical Trial

— HYPNOICU  

Official title:

Impact of Hypnosis During Invasive Procedure in Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399850
• Other study ID #: APHP191042
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: December 18, 2021

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Virginie Lemiale
• Phone: +331 42 49 94 19
• Email: virgnie.lemiale[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 18, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Hypnosis group
Patients who receive hypnosis

Locations

Country	Name	City	State
France	Hôpital Saint-Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain intensity	Pain intensity will be assessed using Numeric rating scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).	within first hour and first 24 hours after procedure
Secondary	Number of adverse events		during procedure
Secondary	Length of each painful procedure		up to 3 months
Secondary	Analgesia dose	The dose of each analgesia treatment received by the patient will be collected.	within first and 24 hours after procedure
Secondary	Type of analgesia	The type of each analgesia treatment received by the patient will be collected.	within first and 24 hours after procedure
Secondary	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).	within first and 24 hours after procedure
Secondary	Hospital Anxiety and Depression 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.; HADS 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.	at 3 months
Secondary	Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)	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)	at 3 months
Secondary	Proportion of patients who had hypnosis transe		during procedure
Secondary	Description of the experience of hypnosis	Qualitative analysis of the experience of hypnosis will be performed using the semi-structured interview	at 3 months