HypnosisHYPNINFNCT06419842
Impact of Hypnosis for Performing Lumbar Infusion Tests
A study testing hypnosis and comfort in people with Hypnosis and Hydrocephalus, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Infusion tests are now the gold standard for the diagnosis of chronic adult hydrocephalus (CAH), also known as normal pressure hydrocephalus. It is an invasive procedure using the same approach as a lumbar puncture. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypnosis, Hydrocephalus, Anxiety
- What is being tested?
- hypnosis and comfort
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2024to Jul 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient over 65 years old undergoing assessment for suspected CAH in day hospitalization for a lumbar infusion test
- No major cognitive impairment (MMSE>20)
Who cannot join
- Patient less than 65 years old
- Major cognitive impairment (MMSE<20)
- History of lumbar surgery
- Contraindication to lumbar puncture or infusion test
- Hearing impairment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Laurence JANIAK, APRN, 0322088943, janiak.laurence@chu-amiens.fr
Cyril CAPEL, MD
About this study
Official title: Evaluation of the Impact of Hypnosis for Performing Lumbar Infusion Tests.
Infusion tests are now the gold standard for the diagnosis of chronic adult hydrocephalus (CAH), also known as normal pressure hydrocephalus. It is an invasive procedure using the same approach as a lumbar puncture. Once the intrathecal puncture is performed, the intracranial pressure is measured in lateral decubitus via a pressure head. Dynamic tests (injection of 0.9% NaCl at a constant flow rate) are performed after recording the basal pressure. This type of test lasts 30 to 45 minutes in lateral decubitus. Patients with CAH have cognitive-behavioral disorders that can alter the gesture and its interpretation in case of movements or contractures. Movement artefacts lead to a longer recording time. The longer the test, the more the patients' tolerance tends to decrease. Moreover, the patient's feeling towards this test is important because it may have to be repeated. Pain, anxiety and patient comfort are essential parameters to consider. Non-medicinal techniques (hypnosis, music therapy) have shown a tendency to reduce anxiety in pediatric and adult populations with an impact on instantaneous anxiety but also on personality-related anxiety. Most studies are focused on specific pathologies, primarily in palliative care, or on pediatric application. The use of these techniques in an elderly population with mild cognitive-behavioral disorders has not been explored.
The objective is to evaluate the impact of hypnosis on anxiety, pain and comfort during the lumbar infusion test.
- Conditions
- Hypnosis, Hydrocephalus, Anxiety, Pain
- Being tested
- hypnosis, comfort
- Keywords
- hypnosis, infusion study, Hydrocephalus, Anxiety, Pain
- Medical subject headings
- Hydrocephalus, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisOther
the patient benefits from a dedicated nurse consultation. During this consultation, the nurse will explain the highlights of the hospitalization, the procedure and anticipate the hypnosis technique to be used. The technique chosen during the consultation will be applied during the test. The nurse is positioned at the head of the patient and with physical contact.
comfortOther
the patient benefits from a nurse consultation. Non-medicinal techniques are not offered. During the infusion test, the nurse will be positioned at the patient's head allowing proximity but without oral or physical intervention.
| Study group | Role | What they receive |
|---|---|---|
| hypnosis | Experimental | In group 1, the patient benefits from a dedicated nurse consultation. During this consultation, the nurse will explain the highlights of the hospitalization, the procedure and anticipate the hypnosis technique to be used. The technique chosen during the consultation will be applied during the test. The nurse is positioned at the head of the patient and with physical contact. Receives: Other: hypnosis |
| comfort | Sham comparator | In group 2, the patient benefits from a nurse consultation. Non-medicinal techniques are not offered. During the infusion test, the nurse will be positioned at the patient's head allowing proximity but without oral or physical intervention. Receives: Other: comfort |
| standard | No intervention | In group 3, the IDE consultation is performed according to the same modalities as in group 2. During the procedure, the nurse will be out of the patient's field of vision and will assist the surgeon in the installation behind the patient. Only the surgeon will interact with the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in anxiety in group 1compared to the other groups
Decrease in anxiety in group 1 compared to the other groups
Measured: 2 years
Secondary outcomes (6)
Decrease in pain in group 1
Decrease in pain on the numerical scale in group 1 versus other groups
Measured: 2 years
Increase in comfort in group 1
Increase in comfort on the numerical scale in group 1 versus the other groups
Measured: 2 years
Better overall patient impression in group 1 versus other groups
Better overall patient impression (Likert scale) in group 1 versus other groups
Measured: 2 years
Less heart rate variation in group 1 versus other groups
Less heart rate variation in group 1 versus other groups
Measured: 2 years
Decreased puncture time required in group 1 versus other groups
Decreased puncture time required in group 1 versus other groups
Measured: 2 years
fewer position changes required in group 1 versus other groups
fewer position changes required in group 1 versus other groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start14 May 2024
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypnosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419842
- Sponsor's protocol ID
- PI2023_843_0149
- Acronym
- HYPNINF
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Hypnosis for Performing Lumbar Infusion Tests.
- ClinicalTrials.gov ID
- NCT06419842
- Acronym / sponsor ID
- HYPNINF / PI2023_843_0149
- Conditions
- Hypnosis, Hydrocephalus, Anxiety, Pain
- Keywords
- hypnosis, infusion study, Hydrocephalus, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 May 2024 (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.
Infusion tests are now the gold standard for the diagnosis of chronic adult hydrocephalus (CAH), also known as normal pressure hydrocephalus. It is an invasive procedure using the same approach as a lumbar puncture. Once the intrathecal puncture is performed, the intracranial pressure is measured in lateral decubitus via a pressure head. Dynamic tests (injection of 0.9% NaCl at a constant flow rate) are performed after recording the basal pressure. This type of test lasts 30 to 45 minutes in lateral decubitus. Patients with CAH have cognitive-behavioral disorders that can alter the gesture and its interpretation in case of movements or contractures. Movement artefacts lead to a longer recording time. The longer the test, the more the patients' tolerance tends to decrease. Moreover, the patient's feeling towards this test is important because it may have to be repeated. Pain, anxiety and patient comfort are essential parameters to consider. Non-medicinal techniques (hypnosis, music therapy) have shown a tendency to reduce anxiety in pediatric and adult populations with an impact on instantaneous anxiety but also on personality-related anxiety. Most studies are focused on specific pathologies, primarily in palliative care, or on pediatric application. The use of these techniques in an elderly population with mild cognitive-behavioral disorders has not been explored.
The objective is to evaluate the impact of hypnosis on anxiety, pain and comfort during the lumbar infusion test.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hypnosis | Experimental | Other: hypnosisIn group 1, the patient benefits from a dedicated nurse consultation. During this consultation, the nurse will explain the highlights of the hospitalization, the procedure and anticipate the hypnosis technique to be used. The technique chosen during the consultation will be applied during the test. The nurse is positioned at the head of the patient and with physical contact. |
| comfort | Sham comparator | Other: comfortIn group 2, the patient benefits from a nurse consultation. Non-medicinal techniques are not offered. During the infusion test, the nurse will be positioned at the patient's head allowing proximity but without oral or physical intervention. |
| standard | No intervention | –In group 3, the IDE consultation is performed according to the same modalities as in group 2. During the procedure, the nurse will be out of the patient's field of vision and will assist the surgeon in the installation behind the patient. Only the surgeon will interact with the patient. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patient over 65 years old undergoing assessment for suspected CAH in day hospitalization for a lumbar infusion test
- No major cognitive impairment (MMSE>20)
Key exclusion criteria (5 listed)
- Patient less than 65 years old
- Major cognitive impairment (MMSE<20)
- History of lumbar surgery
- Contraindication to lumbar puncture or infusion test
- Hearing impairment
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 patient benefits from a dedicated nurse consultation. During this consultation, the nurse will explain the highlights of the hospitalization, the procedure and anticipate the hypnosis technique to be used. The technique chosen during the consultation will be applied during the test. The nurse is positioned at the head of the patient and with physical contact. | Other | hypnosis |
| comfortthe patient benefits from a nurse consultation. Non-medicinal techniques are not offered. During the infusion test, the nurse will be positioned at the patient's head allowing proximity but without oral or physical intervention. | Other | comfort |
Primary outcome
Decrease in anxiety in group 1compared to the other groups
Time frame: 2 years
Decrease in anxiety in group 1 compared to the other groups
6 secondary outcomes
Decrease in pain in group 1
Time frame: 2 years
Increase in comfort in group 1
Time frame: 2 years
Better overall patient impression in group 1 versus other groups
Time frame: 2 years
Less heart rate variation in group 1 versus other groups
Time frame: 2 years
Decreased puncture time required in group 1 versus other groups
Time frame: 2 years
fewer position changes required in group 1 versus other groups
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
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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.
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 and comfort in people with Hypnosis and Hydrocephalus, run by Centre Hospitalier Universitaire, Amiens 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 May 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence JANIAK, APRN (0322088943, janiak.laurence@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in anxiety in group 1compared to the other groups (time frame: 2 years). 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 22 May 2024.