造血器腫瘍患者における幹細胞移植時の仮想現実催眠の利用：実現可能性無作為化研究のプロトコル

Stem cell transplantation is a highly stressful treatment for hematological cancer patients, negatively impacting their quality of life. Hypnosis has proven effective in managing symptoms like pain, fatigue, and anxiety, and improving quality of life. Virtual reality (VR) is used in cancer treatments to distract from pain, and combining VR with hypnosis (VRH) could enhance the hypnotic experience. However, methodological limitations in current studies prevent clear evaluation of its effectiveness, particularly for individualized care and psychosocial interventions.

1) To evaluate the preliminary effects of VRH in reducing anxiety, pain, and fatigue during stem cell transplant, improving quality of life post-intervention. 2) To assess intervention feasibility, including patients' experiences, satisfaction levels, and recommendations for improving the VRH tool.

This study will involve 60 hematology patients divided into two groups: VRH and waiting list. Anxiodepressive symptoms, pain, quality of life, fatigue, absorption, dissociation, and amusement will be assessed before, immediately after the intervention, and at one- and three-month follow-ups using validated psychological scales and numeric rating scales (0-10). Semi-structured interviews will capture patient expectations, satisfaction, and feedback. Data will be analyzed using MANOVA (or non-parametric alternatives) and thematic analysis.

The study's primary goal is to assess VRH's effectiveness compared to standard care in a feasibility randomized controlled trial (RCT). It will also provide data for improving the VRH tool (version 2.0) and assess its usability. In the long term, findings will help integrate VRH into oncology clinics, offering an innovative intervention to support patients throughout treatment.

ClinicalTrials.gov NCT06817759.