Contributions
Abstract: EP1176
Type: E-Poster Presentation
Session title: Quality of life, palliative care, ethics and health economics
Background
The prevention of care-induced pain is a central concern for all healthcare teams in hematology units. Use of MEOPA (Oxygen + Nitrous Oxide) is today a standard of care for relaxation procedure. Distraction through immersion in virtual reality (VR) has already documented its analgesic effects in several phase II trials but comparison with standard treatments in a large randomized study is needed.
Aims
We assessed the safety and efficacy of a new therapeutic virtual reality solution for pain distraction, Bliss©, in prevention of pain and anxiety before performing a bone marrow biopsy.
Methods
We conducted an open-label multicenter randomized phase II/III trial (ClinicalTrials.gov identifier: NCT03483194) in 5 sites in France. Bliss© is a VR software with four imaginary interactive environments in three dimensions. Binaural sound and specific music programs were created to promote immersion and relaxation. The program runs on a smartphone and a GearVR head-mounted display. Efficacy was evaluated by pain intensity with visual analog scale (score from 0 to 10) just after the biopsy and anxiety by 2 questionnaires (fear of pain before the biopsy and revised STAI questionnaire before and after the biopsy). The primary end point was patient-assessed pain intensity after the bone marrow procedure. Statistical analysis was performed with modified intention to treat (Fisher test).
Results
A total of 126 patients were enrolled with previously untreated malignant hemopathy or suspected between September 6, 2018 and May 18, 2020. They were randomly assigned in a 1:1 ratio to receive pain prevention with MEOPA (n=63) or Bliss© (n=63) before and during their bone marrow biopsy. All patients received a local anesthesia with lidocaïne before the biopsy. In addition, patients, nurses and physicians performed efficacy and safety measures during a 1-month follow-up assessment.
Median age of the study population was 65.5 years old (range 18 to 87) and 54.2% were men. The average pain intensity was 3.5 (standard deviation 2.6) for the MEOPA group and 3.0 (SD 2.4) for the VR group (p=0.26), without any significant difference according to age, gender or hemopathy. Concerning anxiety, 67.5% of patients were afraid before the biopsy and anxiety scores were moderate to very high in 26.3% of patients before the biopsy (STAI questionnaire) and 9.0% after the biopsy for all patients without any significant difference between the 2 groups (17.3% of reduction in anxiety for the MEOPA group and 17.2% for the VR group, p=0,83). Immersion in VR was well tolerated in 100% of patients included in the VR group. Physicans were very satisfied by the relaxation procedure in 64.9% of cases (52.5% in the MEOPA group and 77.6% in the VR group, p=0,01) and recommended re-use of the technique in 54.2% in the MEOPA group and 79.1% in the VR group (p=0,02).
Conclusion
The intensity of pain did not significantly differ in both arms. Bliss©-based relaxation method was well tolerated and the satisfaction of patients and physicians was very high in VR group. This study validates the use of immersion in VR with Bliss© as a new digital therapeutics and support the integration of the software in the panel of supportive care.
Keyword(s): Bone marrow biopsy, Pain, Prevention
Abstract: EP1176
Type: E-Poster Presentation
Session title: Quality of life, palliative care, ethics and health economics
Background
The prevention of care-induced pain is a central concern for all healthcare teams in hematology units. Use of MEOPA (Oxygen + Nitrous Oxide) is today a standard of care for relaxation procedure. Distraction through immersion in virtual reality (VR) has already documented its analgesic effects in several phase II trials but comparison with standard treatments in a large randomized study is needed.
Aims
We assessed the safety and efficacy of a new therapeutic virtual reality solution for pain distraction, Bliss©, in prevention of pain and anxiety before performing a bone marrow biopsy.
Methods
We conducted an open-label multicenter randomized phase II/III trial (ClinicalTrials.gov identifier: NCT03483194) in 5 sites in France. Bliss© is a VR software with four imaginary interactive environments in three dimensions. Binaural sound and specific music programs were created to promote immersion and relaxation. The program runs on a smartphone and a GearVR head-mounted display. Efficacy was evaluated by pain intensity with visual analog scale (score from 0 to 10) just after the biopsy and anxiety by 2 questionnaires (fear of pain before the biopsy and revised STAI questionnaire before and after the biopsy). The primary end point was patient-assessed pain intensity after the bone marrow procedure. Statistical analysis was performed with modified intention to treat (Fisher test).
Results
A total of 126 patients were enrolled with previously untreated malignant hemopathy or suspected between September 6, 2018 and May 18, 2020. They were randomly assigned in a 1:1 ratio to receive pain prevention with MEOPA (n=63) or Bliss© (n=63) before and during their bone marrow biopsy. All patients received a local anesthesia with lidocaïne before the biopsy. In addition, patients, nurses and physicians performed efficacy and safety measures during a 1-month follow-up assessment.
Median age of the study population was 65.5 years old (range 18 to 87) and 54.2% were men. The average pain intensity was 3.5 (standard deviation 2.6) for the MEOPA group and 3.0 (SD 2.4) for the VR group (p=0.26), without any significant difference according to age, gender or hemopathy. Concerning anxiety, 67.5% of patients were afraid before the biopsy and anxiety scores were moderate to very high in 26.3% of patients before the biopsy (STAI questionnaire) and 9.0% after the biopsy for all patients without any significant difference between the 2 groups (17.3% of reduction in anxiety for the MEOPA group and 17.2% for the VR group, p=0,83). Immersion in VR was well tolerated in 100% of patients included in the VR group. Physicans were very satisfied by the relaxation procedure in 64.9% of cases (52.5% in the MEOPA group and 77.6% in the VR group, p=0,01) and recommended re-use of the technique in 54.2% in the MEOPA group and 79.1% in the VR group (p=0,02).
Conclusion
The intensity of pain did not significantly differ in both arms. Bliss©-based relaxation method was well tolerated and the satisfaction of patients and physicians was very high in VR group. This study validates the use of immersion in VR with Bliss© as a new digital therapeutics and support the integration of the software in the panel of supportive care.
Keyword(s): Bone marrow biopsy, Pain, Prevention