Virtual nature exposure with hypnosis for hematology patients receiving cellular therapy
| ISRCTN | ISRCTN42049015 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42049015 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Hôpital Maisonneuve-Rosemont |
| Funders | Université de Montréal, Santé |
- Submission date
- 06/11/2025
- Registration date
- 06/11/2025
- Last edited
- 06/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Hematopoietic cell transplant (HCT) is a cornerstone treatment for blood cancers but often causes serious side effects that affect physical and psychological well-being. One major challenge is the mandatory protective isolation that exacerbates anxiodepressive symptoms. Nature exposure is known to improve psychological wellbeing, but the patients’ immunodeficiency prevents contact with real natural settings during HCT. Virtual reality (VR) can reproduce immersive high-intensity natural environments inside the hospital. Coupling nature exposure with VR and hypnosis may increase the benefits of virtual nature exposure. The aim of this study is to determine whether a combined virtual nature exposure and hypnosis intervention improves psychological outcomes (quality of life, anxiety and depression symptoms, pain, fatigue) in patients compared with standard treatment.
Who can participate?
Patients aged over 18 years old who are undergoing autologous or allogeneic HCT for a hematologic malignancy and are sufficiently fluent in French to fully understand the recorded hypnosis sessions.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the experimental group will receive an intervention consisting of virtual exposure sessions to nature environments (forest or beach) combined with hypnosis, each lasting 30 minutes and delivered over a 2-week period. The control group won't have any intervention.
What are the possible benefits and risks of participating?
No direct benefit is known for the moment given the study’s aim to evaluate the effect of the intervention. A minor risk of cybersickness during the intervention could occur.
Where is the study run from?
This study is led at Hôpital Maisonneuve-Rosemont (Montréal, Québec, Canada).
When is the study starting and how long is it expected to run for?
November 2025 to March 2027
Who is funding the study?
This work is supported by the Université de Montréal Maryse and William Brock Chair for clinical research into stem cell transplantation and the Fonds de Recherche du Québec - Oncopole.
Who is the main contact?
Valentyn Fournier, valentyn.fournier@umontreal.ca
Contact information
Public, Scientific, Principal investigator
Hôpital Maisonneuve-Rosemont
5415, boulevard de l'Assomption
Montréal
H1T 2M4
Canada
 ORCID ID |
0000-0002-1289-8968 |
|---|---|
| Phone | +1 (0)4387385583 |
| valentyn.fournier@umontreal.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of combining virtual nature exposure and hypnosis on quality of life in patients with hematologic malignancies undergoing hematopoietic cell transplant: a randomized controlled trial |
| Study acronym | RVH003 |
| Study objectives | The aim of this study is to determine whether an intervention combining virtual nature exposure and hypnosis improves psychological outcomes (quality of life, anxiety and depressive symptoms, pain, and fatigue) in patients with a hematological malignancy treated with hematopoietic cell transplantation. |
| Ethics approval(s) |
Approved 16/09/2025, Research Ethics Committee of Hôpital Maisonneuve-Rosemont (5415, boulevard de l'Assomption, Montréal, H1T 2M4, Canada; +1 (0)5142523400; bcrc.cemtl@ssss.gouv.qc.ca), ref: H1T 2M4 |
| Health condition(s) or problem(s) studied | Psychological outcomes (quality of life, anxiety and depressive symptoms, pain, and fatigue) in patients with a hematological malignancy treated with hematopoietic cell transplantation |
| Intervention | After providing informed consent, participants will be randomly assigned to either the experimental group receiving the intervention or the control group. Allocation will be done following a permutated blocks randomization (blocks size of 4, 6, or 8, randomly fixed) to ensure a global balance and limit predictability of allocation procedure. Allocation list was generated before the beginning of inclusions using the blockrand package (Snow, 2020) for R version 4.5.1. Allocation concealment is ensured by keeping sequence secure and only accessible to the person responsible for inclusions. Participants in the experimental group will receive an intervention consisting of virtual exposure sessions to nature environments (forest or beach) combined with hypnosis, each lasting 30 minutes and delivered over a 2-week period. It will be delivered via a Meta Quest 3 Pro headset. The virtual nature exposure is accompanied by a pre-recorded hypnotic communication played simultaneously . The control group won't have any intervention. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Quality of life measured by the Functional Assessment of Cancer Therapy – Bone Marrow Transplantation (FACT-BMT) questionnaire at pre-transplant (T0: baseline), before the intervention (T1: day +7 ± 1 day post-transplant), after the intervention (T2: day +21 ± 1 day post-transplant), and at 1 month (T3: day +28 ± 2 days) and 3 months (T4: day +100 ±10 days) post-HCT. |
| Key secondary outcome measure(s) |
1. Quality of life Social/Family subscale scores measured by the specific subscale of the Functional Assessment of Cancer Therapy – Bone Marrow Transplantation (FACT-BMT) at pre-transplant (T0: baseline), before the intervention (T1: day +7 ± 1 day post-transplant), after the intervention (T2: day +21 ± 1 day post-transplant), and at 1 month (T3: day +28 ± 2 days) and 3 months (T4: day +100 ±10 days) post-HCT. |
| Completion date | 15/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 94 |
| Key inclusion criteria | 1. Over 18 years old 2. Undergoing autologous or allogeneic HCT for a hematologic malignancy 3. Sufficiently fluent in French to fully understand the recorded hypnosis sessions |
| Key exclusion criteria | 1. Being treated with a HCT at home 2. Received HCT previously 3. Significant cognitive or psychiatric disorders impairing communication with others 4. Sensory impairments (deafness, blindness) that impact participation in the study |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 30/11/2026 |
Locations
Countries of recruitment
- Canada
Study participating centre
Montréal
H1T 2M4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository on OSF |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/11/2025: Study's existence confirmed by the Research Ethics Committee of Hôpital Maisonneuve-Rosemont.
