PainHYPNOPLUSNCT05092906
Contribution of Hypnosis During a Lumbar Puncture.
A study testing LP with complementary hypnoanalgesia in people with Pain, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to assess the effect of hypnosis, as add on therapy, on patients requiring a lumbar puncture (LP) as part of their medical management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- LP with complementary hypnoanalgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2021to 13 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
- Required a lumbar puncture for diagnosis
- Affiliated with social security system
- Patient's written consent
Who cannot join
- LP contraindication
- History of previous LP
- Psychiatric disorder making the realization of a hypnosis irrelevant
- Cognitive-behavioural abilities that do not allow the completion of the study
- Persons who are protected under the act. Person deprived of liberty by judicial decision
- Pregnant or Breastfeeding woman
Trial locations and contacts
1 site in 1 country.
France1 site
Neurology department of Grenoble University Hospital
Grenoble, Isere, 38043
About this study
Official title: Randomized Controlled Study Evaluating The Contribution of a Hypnosis Intervention During a Lumbar Puncture in the Neurology Department.
The purpose of this study is to assess the effect of hypnosis, as add on therapy, on patients requiring a lumbar puncture (LP) as part of their medical management.
Read the detailed description
This study will follow the zelen's methodology randomization. It is an add-on study design.
- The study will be presented to patients as an assessment of their comfort during the LP. The intervention group is not presented to the patient.
- Patients are asked to sign the consent of the standard of care group.
- Randomization into two equally sized groups:
- Intervention arm : LP with complementary hypnoanalgesia
- Control arm : LP without complementary hypnoanalgesia
- Patients who have been randomized into the control group, will have LP according to the standard of care.
Patients who have been randomized into the hypnoanalgesic group will be informed about the hypnoanalgesia intervention and then asked to sign the consent of the hypnosis group.
- if the patient accepts, he will benefit from hypnosis during LP.
- if the patient refuses, he will re-join the control group without hypnosis.
The physicians performing LP will be the same in both groups. A phone call follow-up is scheduled on day 3 and 7 after intervention.
- Conditions
- Pain
- Being tested
- LP with complementary hypnoanalgesia, LP with standard of care
- Keywords
- lumbar puncture, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP with complementary hypnoanalgesiaOther
The lumbar puncture technique will be identical to that of the group standard of care. Hypnosis will be performed by a health professional trained in this practice, in addition to the standard analgesic management.
LP with standard of careOther
The LP will be carried out according to the usual techniques without hypnosis.
Standard analgesic treatments will be used (except contraindications):
- EMLA (Lidocain+Prilocain) Cream/Patch
- Local anesthesia with lidocain chlorhydrate monohydrate 1% injectable
- Nitrous oxide
| Study group | Role | What they receive |
|---|---|---|
| Lumbar puncture with standard of care | Active comparator | Not described Receives: Other: LP with standard of care |
| Lumbar puncture with hypnosis add-on therapy | Experimental | Not described Receives: Other: LP with complementary hypnoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain felt during LP
The maximum pain experienced will be assessed in the immediate post procedure using a Numeric Pain Rating Scale (NPRS). The NPRS is a 10 points scale, ranging from 0 (no pain) to 10 (maximal pain).
Measured: Immediately at the end of LP procedure
Secondary outcomes (6)
Comfort felt during LP
The comfort level felt during the LP procedure will be assessed with a Numeric Rating Scale (NRS). The NRS is a 10 points scale, ranging from 0 (total uncomfort) to 10 (maximal comfort).
Measured: Immediately at the end of LP procedure
Ratio of patients with a Numeric Pain Rating Scale (NPRS) score >= 4.
Comparison between the two groups of the ratio of patient with a NPRS >= 4.
Measured: Immediately at the end of LP procedure
Acceptation of hypnosis
Number and percentage of subjects randomized and analyzed in the hypnoanalgesia group and who have actually had hypnosis
Measured: Day1
State and Trait anxiety before LP
The state and trait anxiety will be assess using the State and Trait anxiety inventory (STAI) questionnaire.
Measured: Before randomization
Assess pain at Day 3 and Day 7
The pain level will be assess using the NPRS scale by telephonic interview.
Measured: Three days and then seven days after the LP.
Timeframe for resumption of usual activities.
Number of days between LP and the resumption of usual activities
Measured: Seven days after the LP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start9 Nov 2021
- Primary completion13 Mar 2024
- Study completion13 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 University Hospital, GrenobleThe 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
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092906
- Sponsor's protocol ID
- 38RC20.357
- Acronym
- HYPNOPLUS
- Status last verified
- Jun 2024
- First submitted
- 16 Sep 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Evaluating The Contribution of a Hypnosis Intervention During a Lumbar Puncture in the Neurology Department.
- ClinicalTrials.gov ID
- NCT05092906
- Acronym / sponsor ID
- HYPNOPLUS / 38RC20.357
- Conditions
- Pain
- Keywords
- lumbar puncture, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 26 Oct 2021 (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.
The purpose of this study is to assess the effect of hypnosis, as add on therapy, on patients requiring a lumbar puncture (LP) as part of their medical management.
Detailed description
This study will follow the zelen's methodology randomization. It is an add-on study design.
- The study will be presented to patients as an assessment of their comfort during the LP. The intervention group is not presented to the patient.
- Patients are asked to sign the consent of the standard of care group.
- Randomization into two equally sized groups:
- Intervention arm : LP with complementary hypnoanalgesia
- Control arm : LP without complementary hypnoanalgesia
- Patients who have been randomized into the control group, will have LP according to the standard of care.
Patients who have been randomized into the hypnoanalgesic group will be informed about the hypnoanalgesia intervention and then asked to sign the consent of the hypnosis group.
- if the patient accepts, he will benefit from hypnosis during LP.
- if the patient refuses, he will re-join the control group without hypnosis.
The physicians performing LP will be the same in both groups. A phone call follow-up is scheduled on day 3 and 7 after intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar puncture with standard of care | Active comparator | Other: LP with standard of care |
| Lumbar puncture with hypnosis add-on therapy | Experimental | Other: LP with complementary hypnoanalgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Required a lumbar puncture for diagnosis
- Affiliated with social security system
- Patient's written consent
Key exclusion criteria (6 listed)
- LP contraindication
- History of previous LP
- Psychiatric disorder making the realization of a hypnosis irrelevant
- Cognitive-behavioural abilities that do not allow the completion of the study
- Persons who are protected under the act. Person deprived of liberty by judicial decision
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 |
|---|---|---|
| LP with complementary hypnoanalgesiaThe lumbar puncture technique will be identical to that of the group standard of care. Hypnosis will be performed by a health professional trained in this practice, in addition to the standard analgesic management. | Other | Lumbar puncture with hypnosis add-on therapy |
| LP with standard of careThe LP will be carried out according to the usual techniques without hypnosis. Standard analgesic treatments will be used (except contraindications): * EMLA (Lidocain+Prilocain) Cream/Patch * Local anesthesia with lidocain chlorhydrate monohydrate 1% injectable * Nitrous oxide | Other | Lumbar puncture with standard of care |
Primary outcome
Maximum pain felt during LP
Time frame: Immediately at the end of LP procedure
The maximum pain experienced will be assessed in the immediate post procedure using a Numeric Pain Rating Scale (NPRS). The NPRS is a 10 points scale, ranging from 0 (no pain) to 10 (maximal pain).
6 secondary outcomes
Comfort felt during LP
Time frame: Immediately at the end of LP procedure
Ratio of patients with a Numeric Pain Rating Scale (NPRS) score >= 4.
Time frame: Immediately at the end of LP procedure
Acceptation of hypnosis
Time frame: Day1
State and Trait anxiety before LP
Time frame: Before randomization
Assess pain at Day 3 and Day 7
Time frame: Three days and then seven days after the LP.
Timeframe for resumption of usual activities.
Time frame: Seven days after the LP.
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 14 Jun 2024.
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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 LP with complementary hypnoanalgesia in people with Pain, run by University Hospital, Grenoble 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 3 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 14 Jun 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?
Maximum pain felt during LP (time frame: Immediately at the end of LP 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 14 Jun 2024.