PainHYPNOICUNCT04399850
Impact of Hypnosis During Invasive Procedure in Intensive Care Unit
A study testing Hypnosis group in people with Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Hypnosis group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2020to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pain
- Being tested
- Hypnosis group
- Keywords
- invasive procedure, pain distress, hypnosis
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis groupOther
Patients who receive hypnosis
| Study group | Role | What they receive |
|---|---|---|
| Patients who receive hypnosis | Experimental | Patients who receive hypnosis during procedure by experiment physician Receives: Other: Hypnosis group |
| Control arm | No intervention | Patient with conventional pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within the before and the first hour after the procedure
Secondary outcomes (10)
Pain intensity
Pain intensity will be assessed using Numeric rating scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).
Measured: within first hour and first 24 hours after procedure
Number of adverse events
Measured: during procedure
Length of each painful procedure
Measured: up to 3 months
Analgesia dose
The dose of each analgesia treatment received by the patient will be collected.
Measured: within first and 24 hours after procedure
Type of analgesia
The type of each analgesia treatment received by the patient will be collected.
Measured: 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).
Measured: 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.
Measured: at 3 months
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)
Measured: at 3 months
Proportion of patients who had hypnosis transe
Measured: during procedure
Description of the experience of hypnosis
Qualitative analysis of the experience of hypnosis will be performed using the semi-structured interview
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start28 Sep 2020
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399850
- Sponsor's protocol ID
- APHP191042
- Acronym
- HYPNOICU
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2020
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hypnosis During Invasive Procedure in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04399850
- Acronym / sponsor ID
- HYPNOICU / APHP191042
- Conditions
- Pain
- Keywords
- invasive procedure, pain distress, hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who receive hypnosis | Experimental | Other: Hypnosis groupPatients who receive hypnosis during procedure by experiment physician |
| Control arm | No intervention | –Patient with conventional pain management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- sedation and intubation, delirium, end-of-life decision,
- deaf patient,
- patient who does not understand French language,
- pregnancy
- patient under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosis groupPatients who receive hypnosis | Other | Patients who receive hypnosis |
Primary outcome
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).
10 secondary outcomes
Pain intensity
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
Time frame: within first and 24 hours after procedure
Type of analgesia
Time frame: within first and 24 hours after procedure
Anxiety
Time frame: within first and 24 hours after procedure
Hospital Anxiety and Depression (HAD) scale
Time frame: at 3 months
Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)
Time frame: at 3 months
Proportion of patients who had hypnosis transe
Time frame: during procedure
Description of the experience of hypnosis
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis group in people with Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain distress (time frame: within the before and the first hour after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.