Skip to content

Impact of Hypnosis for Performing Lumbar Infusion Tests

Evaluation of the Impact of Hypnosis for Performing Lumbar Infusion Tests.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06419842
Acronym
HYPNINF
Enrollment
90
Registered
2024-05-17
Start date
2024-05-14
Completion date
2026-07-31
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Hydrocephalus, Hypnosis, Pain

Keywords

hypnosis, infusion study, Hydrocephalus, Anxiety, Pain

Brief 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. 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.

Interventions

OTHERhypnosis

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.

OTHERcomfort

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.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient over 65 years old undergoing assessment for suspected CAH in day hospitalization for a lumbar infusion test * No major cognitive impairment (MMSE\>20)

Exclusion criteria

* Patient less than 65 years old * Major cognitive impairment (MMSE\<20) * History of lumbar surgery * Contraindication to lumbar puncture or infusion test * Hearing impairment

Design outcomes

Primary

MeasureTime frameDescription
Decrease in anxiety in group 1compared to the other groups2 yearsDecrease in anxiety in group 1 compared to the other groups

Secondary

MeasureTime frameDescription
Increase in comfort in group 12 yearsIncrease in comfort on the numerical scale in group 1 versus the other groups
Better overall patient impression in group 1 versus other groups2 yearsBetter overall patient impression (Likert scale) in group 1 versus other groups
Decrease in pain in group 12 yearsDecrease in pain on the numerical scale in group 1 versus other groups
Decreased puncture time required in group 1 versus other groups2 yearsDecreased puncture time required in group 1 versus other groups
fewer position changes required in group 1 versus other groups2 yearsfewer position changes required in group 1 versus other groups
Less heart rate variation in group 1 versus other groups2 yearsLess heart rate variation in group 1 versus other groups

Countries

France

Contacts

Primary ContactLaurence JANIAK, APRN
janiak.laurence@chu-amiens.fr0322088943

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026