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NCT Number: NCT06419842

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Cyril CAPEL, MD

SUB_INVESTIGATOR

Laurence JANIAK, APRN

CONTACT

[email protected]

0322088943

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypnosis

Other

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

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Decrease in pain in group 1

    Time frame: 2 years

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

  2. Increase in comfort in group 1

    Time frame: 2 years

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

  3. Better overall patient impression in group 1 versus other groups

    Time frame: 2 years

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

  4. Less heart rate variation in group 1 versus other groups

    Time frame: 2 years

    Less heart rate variation in group 1 versus other groups

  5. Decreased puncture time required in group 1 versus other groups

    Time frame: 2 years

    Decreased puncture time required in group 1 versus other groups

  6. fewer position changes required in group 1 versus other groups

    Time frame: 2 years

    fewer position changes required in group 1 versus other groups

Study contacts

Contact information is provided by the study sponsor or research team.

Laurence JANIAK, APRN

CONTACT

[email protected]

0322088943

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: HYPNINF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 17, 2024
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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