Development of an Intervention Integrating Procedures Combining Hypnosis and Virtual Reality in the Support of Patients with Hematological Cancer

NCT06817759 | Not Yet Recruiting

• 1 other identifier: 2023-3251
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Research into cancer patients has shown that quality of life is significantly altered by the disease and its associated treatments and is also reported to be a predictor of significant emotional distress. Blood cancer patients are among those most affected in terms of quality of life, facing stem cell transplantation after high-dose chemotherapy, a treatment that is recognized as one of the most stressful of cancer therapy, due to the many adverse effects, including pain, and the uncertainty linked to the fear of graft failure. Hypnosis interventions are proving effective in treating common side effects: nausea, pain, fatigue, anxiety, depressive symptoms and improving overall quality of life, and other interventions, based on virtual reality, have shown promising effects on patients' distress and acute pain. The aim of this study is to evaluate the effects of an intervention program combining hypnosis and virtual reality in assisting myeloma and lymphoma patients during stem cell transplantation, with a view to improving their quality of life during this period. The project aims to assess the validity of the intervention, and to evaluate the effects of the intervention on patients' anxiety, pain and fatigue during transplantation. The validity of the intervention will be measured by a questionnaire assessing the relevance and acceptability of the intervention, expected effects, and practical implementation. Socio-demographic and clinical data will be collected from patients, including axiety, pain, fatigue and quality of life, studied at pre (one week after transplantation) and post (one month after transplantation) intervnention, and at follow-up (three month after transplantation).

Conditions

Blood Cancer; Multiple Myeloma (MM); Lymphoma

Keywords

Virtual reality hypnosis; Quality of life; Blood cancer; Oncology; multiple myeloma; lymphoma; hypnosis; virtual reality; hematology; anxiety; pain; stem cells transplantation

Outcome Measures

Primary Outcomes (2)

• Anxiety and depression

  Anxiety-depression will be measured using the Hospital anxiety and depression scale (HADS), a scale validated in French for cancer. This scale is made up of 14 items: 7 items determine the degree of anxiety and the other 7, the degree of depression. The score of each subscale is calculated by summing the score of each item, which varies between 0 and 3, so that each subscale can reach a maximum score of 21

  Studied one week, one month and three months post-transplantation

• Level of pain

  Pain will be assessed with the Brief Pain Inventory. This scale is made of 8 items on a 10-points Lickert scale (0=no pain, 10=worst pain) assessing severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week.

  Studied one week, one month and three months post-transplantation

Secondary Outcomes (11)

• Level of quality of life

  Studied one week, one month and three months post-transplantation

• Absorption

  Studied immediately before and after each use of the intervention 4 times during the two weeks in possession of the VR headset.

• Dissociation

  Studied immediately before and after each use of the intervention 4 times during the two weeks in possession of the VR headset.

• Level of expectation and satisfaction

  Measured respectively one week post-transplantation and three months post-transplantation

• Cybersickness

  Measured after each use of the intervention 4 times during the two weeks in possession of the VR headset.

Study Arms (2)

Intervention (VRH) group

EXPERIMENTAL

Four obligatory accompanied session of VRH and use of VRH as needed.

Device: Virtual Reality Hypnosis; Device: VRH : Beach; Device: VRH : Forest; Device: VRH : MagicHand; Device: VRH : SecurityProtection

Control group

NO INTERVENTION

Standard of care (waiting list, will receive VRH following the study).

Interventions

Virtual Reality Hypnosis DEVICE

An intervention program (VRH) that combines VR and hypnosis; Can use it whenever and how much they want. It contains 200 landscapes in VR and 4 different VRH sessions

Intervention (VRH) group

VRH : Beach DEVICE

Hypnosis session with a VR immersion at the beach; one accompanied session

Intervention (VRH) group

VRH : Forest DEVICE

Hypnosis session with a VR immersion in forests; one accompanied session

Intervention (VRH) group

VRH : MagicHand DEVICE

Hypnosis session with a VR immersion with techniques to reduce pain; one accompanied session

Intervention (VRH) group

VRH : SecurityProtection DEVICE

Hypnosis session with a VR immersion with techniques to reduce anxiety; one accompanied session

Intervention (VRH) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years of age or older
• Suffering from multiple myeloma or lymphoma eligible for transplant
• Understanding French

You may not qualify if:

• Deafness
• Blindness
• Confusion or psychopathological disorders (for example, schizophrenia) that may impair communication

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Centre de Recherche de l'Hôpital Maissonneuve-Rosemont

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Multiple Myeloma; Lymphoma; Neoplasms; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Ogez, Ph.D

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Ogez, Ph.D

CONTACT

514-609-4391; david.ogez@umontreal.ca

Floriane Rousseaux, Ph.D

CONTACT

438-543-1878; floriane.rousseaux@hotmail.com

Study Design

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

Model Details: participants will be recruited and randomly assigned to two conditions: VRH, and a control condition (C) (waiting-list, will receive the intervention after the end of the study)

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 10, 2025
• Study Start: February 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Supporting information will be available from the definitive publication of results.
• Access Criteria: All IPD that underlie results in a publication will be shared in a dedicated OSF repository,

Locations

CA (1)