Invasive ProcedureHYPICNCT04129333
HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit
A study testing Hypnosis and No hypnosis in people with Invasive Procedure, run by Rennes University Hospital at 2 sites in France.
Trial summary
Procedural pain in resuscitation is common in the conscious patient. However, analgesia and sedation may be impossible because of the acute pathology leading to resuscitation, comorbidities or the urgency of the invasive procedure. In addition, the use of analgesics and sedatives is responsible for adverse effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Procedure
- What is being tested?
- Hypnosis and No hypnosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Dec 2019to 11 Oct 2022
- 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
- Major patient admitted to intensive care
- Glasgow score = 15
- Necessity during the stay of making an invasive gesture among:
- Thoracic drainage
- Placement of a central venous catheter or a Swan-Ganz catheter
- Establishment of a dialysis catheter
Show all 20Show fewer
- Introduction of an invasive arterial catheter
- Patient giving free, informed and written consent
- Patient affiliated to a social security scheme
- Non inclusion Criteria:
- Procedure to be carried out in extreme urgency
- Confusional state making hypnosis impossible, evaluated by CAM-ICU (Confusion Assessment Method for the Intensive Care Unit)
- Decompensated psychiatric illness
- Patient sedated or intravenous analgesia continued at the time of the procedure
- Patient intubated
- Patient with a contraindication to sedation or analgesia at the time of the procedure
- Patient receiving topical anesthesia before the start of the procedure
- Major person subject to legal protection (court bail, curator, guardianship) or deprived of liberty
- Patient already included in the study during the completion of a previous invasive procedure
- Patient participating in a research involving an interventional human person (category 1) on an analgesic / sedative drug
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Rennes University Hospital
Rennes, 35033
Saint-Brieuc Hospital
Saint-Brieuc, Brittany Region, 22000
About this study
Procedural pain in resuscitation is common in the conscious patient. However, analgesia and sedation may be impossible because of the acute pathology leading to resuscitation, comorbidities or the urgency of the invasive procedure. In addition, the use of analgesics and sedatives is responsible for adverse effects. In this context, hypnosis appears to be an additional analgesic tool that would reduce the consumption of analgesics and sedatives and thus reduce their side effects.
- Conditions
- Invasive Procedure
- Being tested
- Hypnosis, No hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
The hypnosis session :
- Creation of the therapist-patient link
- Choice of a theme and the preferred sensory channel by the patient
- Collection of the theme chosen by the patient
- Orientation in the here and now.
- Induction
- Realization of the gesture and hypnosis
- At the end of the procedure, reassociation of the patient in the here and now
No hypnosisOther
No hypnosis
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis group | Experimental | A hypnosis group with standard care during the invasive procedure according to the usual practice of the care team and setting up a hypnotic accompaniment by an nurse trained beforehand and dedicated throughout the gesture. The hypnosis session will end at the same time as the invasive procedure. Receives: Other: Hypnosis |
| Control group | Placebo comparator | A control group with standard care during the invasive procedure according to the usual practice of the care team. Receives: Other: No hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Oral assessment scale (0 : no pain - 10 : maximal pain)
Measured: Immediately after the end of the invasive procedure (Hour 0)
Secondary outcomes (11)
Pain assessment
Oral assessment scale (0 : no pain - 10 : maximal pain)
Measured: The first hour after the end of the procedure (Hour 1)
Morphine equivalent dose
Cumulative use of morphine-morphine analgesics in morphine equivalent during the procedure and the first hour after the end of the procedure (H1)
Measured: Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)
Sedatives dose
Cumulative use of sedatives during the procedure and the first hour after the end of the procedure (H1)
Measured: Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)
Local Anesthesia dose
Consumption of local anesthesia during the invasive procedure
Measured: Immediately after the end of the invasive procedure (Hour 0)
Comfort scale
Comfort measured by the numerical comfort scale (0 no comfort - 10 most comfortable situation imaginable)
Measured: Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)
Anxiety
Patient anxiety measured by the numerical anxiety scale (0 no anxiety - 10 greatest anxiety imaginable) .
Measured: Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)
Duration
Duration of the invasive procedure including the period of hypnosis
Measured: Immediately after the end of the invasive procedure (Hour 0)
Number of attempts and failures of the procedure
Number of attempts and failures of the procedure
Measured: The first hour after the end of the procedure (Hour 1)
Adverse events
Number of adverse events occurring during the procedure (hematoma, failure to pose, ...)
Measured: The first hour after the end of the procedure (Hour 1)
Nurse stress
Stress of the nurse in charge of the patient quantified by a numerical scale of evaluation (0 no stress - 10 greatest stress imaginable)
Measured: Immediately after the end of the invasive procedure (Hour 0)
Length of stay in intensive care unit
Length of stay in intensive care unit, measured until D28
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start30 Dec 2019
- Primary completion25 Jan 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive ProcedureStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter prospective national, controlled, randomized, superiority study, open-label with blind evaluation, on 2 parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129333
- Sponsor's protocol ID
- 35RC18_8853_HYPIC
- Other IDs
- 2019-A01775-52
- Acronym
- HYPIC
- Status last verified
- Nov 2022
- First submitted
- 14 Oct 2019
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maamar A, Faleur C, Pedrono K, Adeux MP, Anne M, Verdes A, Fillatre P, Debarre M, Mercier N, Revest M, Massart N, Poilvet N, Terzi N, Tadie JM, Gacouin A, Laviolle B. Hypnosis for unplanned procedural pain in the intensive care unit: the HYPIC randomized clinical trial. Crit Care. 2025 Jul 18;29(1):312. doi: 10.1186/s13054-025-05563-9.
PubMed 40682163
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04129333
- Acronym / sponsor ID
- HYPIC / 35RC18_8853_HYPIC
- Conditions
- Invasive Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 16 Oct 2019 (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.
Procedural pain in resuscitation is common in the conscious patient. However, analgesia and sedation may be impossible because of the acute pathology leading to resuscitation, comorbidities or the urgency of the invasive procedure. In addition, the use of analgesics and sedatives is responsible for adverse effects. In this context, hypnosis appears to be an additional analgesic tool that would reduce the consumption of analgesics and sedatives and thus reduce their side effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter prospective national, controlled, randomized, superiority study, open-label with blind evaluation, on 2 parallel groups
| Arm | Type | Receives |
|---|---|---|
| Hypnosis group | Experimental | Other: HypnosisA hypnosis group with standard care during the invasive procedure according to the usual practice of the care team and setting up a hypnotic accompaniment by an nurse trained beforehand and dedicated throughout the gesture. The hypnosis session will end at the same time as the invasive procedure. |
| Control group | Placebo comparator | Other: No hypnosisA control group with standard care during the invasive procedure according to the usual practice of the care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Major patient admitted to intensive care
- Glasgow score = 15
- Necessity during the stay of making an invasive gesture among:
- Thoracic drainage
- Placement of a central venous catheter or a Swan-Ganz catheter
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HypnosisThe hypnosis session : * Creation of the therapist-patient link * Choice of a theme and the preferred sensory channel by the patient * Collection of the theme chosen by the patient * Orientation in the here and now. * Induction * Realization of the gesture and hypnosis * At the end of the procedure, reassociation of the patient in the here and now | Other | Hypnosis group |
| No hypnosisNo hypnosis | Other | Control group |
Primary outcome
Pain assessment
Time frame: Immediately after the end of the invasive procedure (Hour 0)
Oral assessment scale (0 : no pain - 10 : maximal pain)
11 secondary outcomes
Pain assessment
Time frame: The first hour after the end of the procedure (Hour 1)
Morphine equivalent dose
Time frame: Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)
Sedatives dose
Time frame: Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)
Local Anesthesia dose
Time frame: Immediately after the end of the invasive procedure (Hour 0)
Comfort scale
Time frame: Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)
Anxiety
Time frame: Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)
Duration
Time frame: Immediately after the end of the invasive procedure (Hour 0)
Number of attempts and failures of the procedure
Time frame: The first hour after the end of the procedure (Hour 1)
Adverse events
Time frame: The first hour after the end of the procedure (Hour 1)
Nurse stress
Time frame: Immediately after the end of the invasive procedure (Hour 0)
Length of stay in intensive care unit
Time frame: Day 28
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 9 Nov 2022.
- Derived from this study: PubMed 40682163Maamar A, Faleur C, Pedrono K, Adeux MP, Anne M, Verdes A, Fillatre P, Debarre M, Mercier N, Revest M, Massart N, Poilvet N, Terzi N, Tadie JM, Gacouin A, Laviolle B. Hypnosis for unplanned procedural pain in the intensive care unit: the HYPIC randomized clinical trial. Crit Care. 2025 Jul 18;29(1):312. doi: 10.1186/s13054-025-05563-9.
- Individual participant dataSharing planned: No
Related trials for Invasive Procedure
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
Active, not recruitingObservational study
Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation
Humidifier Lung, Mechanical Fragility
RecruitingPhase 2
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Non-muscle Invasive Bladder Cancer
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis and No hypnosis in people with Invasive Procedure, run by Rennes University Hospital at 2 sites 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 20 inclusion and 0 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 assessment (time frame: Immediately after the end of the invasive procedure (Hour 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129333, which also lists 1 linked publication.
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 9 Nov 2022.