## Protocol Section
### Identification Module
**NCT ID:** NCT06419842

**Acronym:** HYPNINF

**Brief Title:** Impact of Hypnosis for Performing Lumbar Infusion Tests

**Official Title:** Evaluation of the Impact of Hypnosis for Performing Lumbar Infusion Tests.

#### Organization Study ID Info
**ID:** PI2023_843_0149
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire, Amiens
### Status Module
#### Completion Date
**Date:** 2026-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire, Amiens

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hypnosis

- Hydrocephalus

- Anxiety

- Pain

**Keywords:**

- hypnosis

- infusion study

- Hydrocephalus

- Anxiety

- Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: hypnosis

**Label:** hypnosis

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: comfort

**Label:** comfort

**Type:** SHAM_COMPARATOR

#### Arm Group 3

**Description:** 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.

**Label:** standard

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- hypnosis

**Description:** 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.

**Name:** hypnosis

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- comfort

**Description:** 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.

**Name:** comfort

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Decrease in anxiety in group 1 compared to the other groups

**Measure:** Decrease in anxiety in group 1compared to the other groups

**Time Frame:** 2 years

#### Secondary Outcomes

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

**Measure:** Decrease in pain in group 1

**Time Frame:** 2 years

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

**Measure:** Increase in comfort in group 1

**Time Frame:** 2 years

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

**Measure:** Better overall patient impression in group 1 versus other groups

**Time Frame:** 2 years

**Description:** Less heart rate variation in group 1 versus other groups

**Measure:** Less heart rate variation in group 1 versus other groups

**Time Frame:** 2 years

**Description:** Decreased puncture time required in group 1 versus other groups

**Measure:** Decreased puncture time required in group 1 versus other groups

**Time Frame:** 2 years

**Description:** fewer position changes required in group 1 versus other groups

**Measure:** fewer position changes required in group 1 versus other groups

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** janiak.laurence@chu-amiens.fr

**Name:** Laurence JANIAK, APRN

**Phone:** 0322088943

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Amiens

**Contacts:**

***Contact 1:***

- **Email:** janiak.laurence@chu-amiens.fr

- **Name:** Laurence JANIAK, APRN

- **Phone:** 0322088943

- **Role:** CONTACT

***Contact 2:***

- **Name:** Cyril CAPEL, MD

- **Role:** SUB_INVESTIGATOR

**Country:** France

**Facility:** CHU Amiens Picardie

**State:** Picardie

**Status:** RECRUITING

**Zip:** 80054

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M9907

- Name: Hydrocephalus

- Relevance: HIGH

- As Found: Hydrocephalus

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006849

- Term: Hydrocephalus

### Misc Info Module

- Version Holder: 2024-05-31
