Observational Prospective Study Measuring the Impact of the Use of a Hypnotic Script Associated With Virtual Reality on the Pain of the Child's Sickle Cell During a Vaso-occlusive Crisis

NCT04917120 | Completed

• 2 other identifiers: APHP201280IDRCB2020-AO2248-31
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of Virtual Reality induced Hypnosis on patients' pain scores, anxiety and the use of analgesics during a vaso-occlusive crisis

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease; Pain; Virtual reality; Vaso occlusive crises; Hypnosis

Outcome Measures

Primary Outcomes (1)

• pain assessment with score (patient)

  Measuring pain thanks to score pain by the patient 3 hours after a Virtual Reality session performed within the first 6 hours after arrival in the general pediatrics unit Patients will use le Faces Pain Scale - Revised.

  hours 3 after a virtual reality

Secondary Outcomes (10)

• pain assessment with score (patient)

  10 minutes before HVR

• pain assessment with score (patient)

  1 hour after a virtual reality

• pain assessment with score (health care personnel)

  10 minutes before HVR

• pain assessment with score (health care personnel)

  1 hour after a virtual reality

• pain assessment with score (health care personnel)

  3 hour after a virtual reality

Study Arms (1)

VRH (virtual reality hypnosis)

EXPERIMENTAL

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

The procedure will consist of a virtual reality program associated with suggestions of hypnoanalgesia, be added to usual care. Included patients will benefit from the Virtual Reality program combined with hypnoanalgesia suggestions for a period of 20 minutes. We will use a helmet with a built-in screen and an audio headset connected to a control room. Patients will watch an Virtual Reality sequence while listening to narratives designed for the hypnoanalgesia of the present pain.

VRH (virtual reality hypnosis)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Child over 6 years of age on the day of acceptance of the study (no upper limit)
• Suffering from sickle cell disease whatever genotype
• Admission in hospital for a VOC (vaso-occlusive crisis)
• Informed and signed consent by at least one legal guardian, if child is minor, and verbal agreement of the child himself.

You may not qualify if:

• Deaf patient, visually impaired patient, claustrophobic and/or aquaphobic patient
• Patient not understanding French
• History of psychiatric illness such as paranoia, schizophrenia, manic-depressive psychosis, high suicide risk patient.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Trousseau Hospital, General pediatric departement

Paris, 75012, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain; Vaso-Occlusive Crises

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie DUGUE

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: June 8, 2021
• Study Start: July 13, 2021
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: September 16, 2025

Record last verified: 2025-05

Locations

FR (1)