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

Condition(s) studied

Investigational drug(s) / intervention(s)

Virtual Reality Hypnosis: 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

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

VRH : Forest: Hypnosis session with a VR immersion in forests; one accompanied session

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

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

Study 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).

Eligibility

Primary outcome measure(s)

• Anxiety and depression — Studied one week, one month and three months post-transplantation
  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
• Level of pain — Studied one week, one month and three months post-transplantation
  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.

Trial sites (1)

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