Impact of Hypnosis for Performing Lumbar Infusion Tests

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient over 65 years old undergoing assessment for suspected CAH in day hospitalization for a lumbar infusion test

No major cognitive impairment (MMSE>20)

Disqualifiers

Patient less than 65 years old

Major cognitive impairment (MMSE<20)

History of lumbar surgery

Contraindication to lumbar puncture or infusion test

Trial design

Design model

Parallel

Treatments tested in this trial

  • hypnosis

    Other intervention

    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

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: hypnosisExperimental treatment 1 intervention
Group B: comfortSham comparator 1 intervention
Group C: standardNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Decrease in anxiety in group 1compared to the other groups

Decrease in anxiety in group 1 compared to the other groups

Time frame
2 years

Secondary outcomes

1

Decrease in pain in group 1

Decrease in pain on the numerical scale in group 1 versus other groups

Time frame
2 years
2

Increase in comfort in group 1

Increase in comfort on the numerical scale in group 1 versus the other groups

Time frame
2 years
3

Better overall patient impression in group 1 versus other groups

Better overall patient impression (Likert scale) in group 1 versus other groups

Time frame
2 years
4

Less heart rate variation in group 1 versus other groups

Less heart rate variation in group 1 versus other groups

Time frame
2 years

Other outcomes

Sponsors and contacts

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