Virtual Reality Hypnosis for Blood Cancers

Overseen By Floriane Rousseaux, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Disqualifiers: Deafness, Blindness, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

60 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Virtual Reality Hypnosis for Blood Cancers?

Research shows that hypnosis can significantly reduce pain and anxiety in adolescents with cancer during medical procedures. Additionally, virtual reality has been found to improve mood and reduce anxiety in cancer patients, suggesting that combining these approaches could be beneficial for blood cancer patients. ^{1 2 3 4 5}

Is Virtual Reality Hypnosis safe for use in humans?

Research on hypnosis, including its use in cancer treatment, shows it is generally safe for reducing pain and anxiety, with no significant adverse effects reported in the studies reviewed. ^{1 2 5 6 7}

How is the Virtual Reality Hypnosis treatment different from other treatments for blood cancers?

This treatment is unique because it combines hypnosis, which helps manage symptoms like pain and anxiety, with virtual reality, creating an immersive experience that can enhance the effectiveness of hypnosis without any side effects. ^{8 9 10 11 12}

What is the purpose of this trial?

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).

Research Team

David Ogez, Ph.D

Principal Investigator

Université de Montréal

Eligibility Criteria

This trial is for patients with blood cancers like multiple myeloma and lymphoma, who are undergoing stem cell transplantation after high-dose chemotherapy. Participants should be willing to try a program combining hypnosis and virtual reality aimed at improving quality of life.

Inclusion Criteria

I have multiple myeloma or lymphoma and am eligible for a transplant.

I understand French.

Exclusion Criteria

Deafness

Blindness

Confusion or psychopathological disorders that may impair communication (e.g., schizophrenia)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention

Participants complete self-evaluations and interviews to gather expectations and satisfaction levels

1 week

1 visit (in-person)

Intervention

Participants undergo VRH sessions to reduce anxiety, pain, and fatigue, using the VR headset for two weeks

2 weeks

4 sessions (in-person)

Post-Intervention

Participants complete post-intervention evaluations one month after transplantation

1 month

Follow-up

Participants are monitored for safety and effectiveness three months after transplantation

3 months

1 visit (in-person)

Treatment Details

Interventions

• Intervention Integrating Procedures Combining Hypnosis and Virtual Reality

Trial Overview The study tests an innovative support intervention that combines hypnosis with virtual reality environments (like forests or beaches) to help manage pain, anxiety, and fatigue in blood cancer patients during stem cell transplantation.

Participant Groups

Group I: Intervention (VRH) group Experimental Treatment 5 Interventions

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

Group II: Control group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Findings from Research

In a study involving 52 women with cervical cancer undergoing radiochemotherapy, guided imagery relaxation through virtual reality showed a significant reduction in anxiety traits before the intervention, indicating that participants were experiencing high anxiety levels.

Although the reduction in anxiety levels between the 4th and 12th week of follow-up was not statistically significant, the intervention suggests potential benefits for clinical practice in managing anxiety for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of guided imagery relaxation on anxiety in cervical cancer: randomized clinical trial. Santana, EO., Silva, LDS., Silva, LAAD., et al.[2023]

In a randomized crossover trial involving 50 cancer patients undergoing chemotherapy, Virtual Reality (VR) significantly improved mood states compared to Guided Imagery (GI), indicating its potential as a beneficial intervention for emotional well-being during treatment.

The VR intervention also led to statistically significant improvements in biophysical parameters like blood pressure and heart rate, although it did not show effectiveness in reducing symptoms of nausea, pain, or feeling sick.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. Ioannou, A., Paikousis, L., Papastavrou, E., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hypnotherapy in radiotherapy patients: a randomized trial. [2006]

2. Germany pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of hypnosis-derived communication administered by trained nurses to improve patient well-being during outpatient chemotherapy: a pilot-controlled trial. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Effect of guided imagery relaxation on anxiety in cervical cancer: randomized clinical trial. [2023]

4. Scotland pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality Vs Guided Imagery on mood changes in cancer patients receiving chemotherapy treatment: A crossover trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Adolescents with cancer. Hypnosis for the reduction of the acute pain and anxiety associated with medical procedures. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Beneficial effects of hypnosis and adverse effects of empathic attention during percutaneous tumor treatment: when being nice does not suffice. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Hypnosis for nausea and vomiting in cancer chemotherapy: a systematic review of the research evidence. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The use of hypnosis with cancer patients. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The Role of Hypnosis in Cancer Care. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Hypnosis for cancer care: over 200 years young. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Use of hypnosis for multiple symptoms in an adolescent girl with leukemia. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Applications of Hypnosis as an Adjuvant in Oncological Settings: A Systematic Review. [2023]