A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study
BackgroundEvidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain has been documented in several phase 2 trials, but comparison with standard treatments in large, randomized studies is needed. Objectiv...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2023-02-01
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| Series: | Journal of Medical Internet Research |
| Online Access: | https://www.jmir.org/2023/1/e38619 |
| _version_ | 1827857567583305728 |
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| author | Katell Le Du Anne-Lise Septans Frédéric Maloisel Hélène Vanquaethem Anna Schmitt Marielle Le Goff Aline Clavert Marie Zinger Hugues Bourgeois Olivier Dupuis Fabrice Denis Stéphane Bouchard |
| author_facet | Katell Le Du Anne-Lise Septans Frédéric Maloisel Hélène Vanquaethem Anna Schmitt Marielle Le Goff Aline Clavert Marie Zinger Hugues Bourgeois Olivier Dupuis Fabrice Denis Stéphane Bouchard |
| author_sort | Katell Le Du |
| collection | DOAJ |
| description |
BackgroundEvidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain has been documented in several phase 2 trials, but comparison with standard treatments in large, randomized studies is needed.
ObjectiveIn this open-label, multicenter, randomized, phase 3 trial, we evaluated the safety and efficacy of a novel VR therapy solution for distraction in the context of bone marrow biopsy.
MethodsBliss is a VR software with 4 imaginary interactive environments in 3 dimensions with binaural sound (head-mounted display). Efficacy regarding pain intensity was evaluated using a visual analog scale (VAS; score from 0 to 10) immediately after the biopsy. Secondary end points were anxiety and tolerance. Modified intention-to-treat analysis was performed.
ResultsOverall, 126 patients with previously documented untreated or suspected malignant hemopathy between September 6, 2018, and May 18, 2020, were randomly assigned in a 1:1 ratio to receive pain prevention with a mixture of nitrous oxide/oxygen (MEOPA; n=63) or VR (n=63) before and during the bone marrow biopsy. We excluded 8 patients from the final analysis (3 in the MEOPA group and 5 in the VR group). All patients received local anesthesia (lidocaine) before biopsy. Follow-up was limited to 1 month after the biopsy. Participants’ median age was 65.5 (range 18-87) years, and 54.2% (64/118) of patients were male. The average pain intensity was 3.5 (SD 2.6, 95% CI –1.6 to 8.6) for the MEOPA group and 3.0 (SD 2.4, 95% CI –1.7 to 7.7) for the VR group, without any significant differences in age, sex, center, and hemopathy (P=.26). Concerning anxiety, 67.5% (79/117; fear of pain questionnaire) of the patients were afraid before the biopsy, and anxiety scores were moderate to very high in 26.3% (30/114; revised Spielberger State-Trait Anxiety Inventory questionnaire) of the patients before the biopsy and 9.0% (10/114) after the biopsy for all patients, without a significant difference between the 2 groups (P=.83). Immersion in VR was well tolerated by the majority (54/57, 95%) of patients in the VR group.
ConclusionsThe intensity of pain did not significantly differ between both arms. VR was well tolerated, and the satisfaction of patients, nurses, and physicians was very high. VR could be an alternative treatment in case of contraindication or intolerance to MEOPA.
Trial RegistrationClinicalTrials.gov NCT03483194; https://clinicaltrials.gov/ct2/show/NCT03483194 |
| first_indexed | 2024-03-12T12:42:24Z |
| format | Article |
| id | doaj.art-7194f235a2b9401da09705c862f051ae |
| institution | Directory Open Access Journal |
| issn | 1438-8871 |
| language | English |
| last_indexed | 2024-03-12T12:42:24Z |
| publishDate | 2023-02-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | Journal of Medical Internet Research |
| spelling | doaj.art-7194f235a2b9401da09705c862f051ae2023-08-28T23:45:14ZengJMIR PublicationsJournal of Medical Internet Research1438-88712023-02-0125e3861910.2196/38619A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 StudyKatell Le Duhttps://orcid.org/0000-0003-4371-2668Anne-Lise Septanshttps://orcid.org/0000-0002-9707-270XFrédéric Maloiselhttps://orcid.org/0000-0002-6466-2746Hélène Vanquaethemhttps://orcid.org/0000-0002-8262-9085Anna Schmitthttps://orcid.org/0000-0002-6303-3294Marielle Le Goffhttps://orcid.org/0000-0002-0457-5763Aline Claverthttps://orcid.org/0000-0003-1270-848XMarie Zingerhttps://orcid.org/0000-0002-9037-7287Hugues Bourgeoishttps://orcid.org/0000-0001-6682-4916Olivier Dupuishttps://orcid.org/0000-0002-8027-7725Fabrice Denishttps://orcid.org/0000-0002-2190-7782Stéphane Bouchardhttps://orcid.org/0000-0002-5995-340X BackgroundEvidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain has been documented in several phase 2 trials, but comparison with standard treatments in large, randomized studies is needed. ObjectiveIn this open-label, multicenter, randomized, phase 3 trial, we evaluated the safety and efficacy of a novel VR therapy solution for distraction in the context of bone marrow biopsy. MethodsBliss is a VR software with 4 imaginary interactive environments in 3 dimensions with binaural sound (head-mounted display). Efficacy regarding pain intensity was evaluated using a visual analog scale (VAS; score from 0 to 10) immediately after the biopsy. Secondary end points were anxiety and tolerance. Modified intention-to-treat analysis was performed. ResultsOverall, 126 patients with previously documented untreated or suspected malignant hemopathy between September 6, 2018, and May 18, 2020, were randomly assigned in a 1:1 ratio to receive pain prevention with a mixture of nitrous oxide/oxygen (MEOPA; n=63) or VR (n=63) before and during the bone marrow biopsy. We excluded 8 patients from the final analysis (3 in the MEOPA group and 5 in the VR group). All patients received local anesthesia (lidocaine) before biopsy. Follow-up was limited to 1 month after the biopsy. Participants’ median age was 65.5 (range 18-87) years, and 54.2% (64/118) of patients were male. The average pain intensity was 3.5 (SD 2.6, 95% CI –1.6 to 8.6) for the MEOPA group and 3.0 (SD 2.4, 95% CI –1.7 to 7.7) for the VR group, without any significant differences in age, sex, center, and hemopathy (P=.26). Concerning anxiety, 67.5% (79/117; fear of pain questionnaire) of the patients were afraid before the biopsy, and anxiety scores were moderate to very high in 26.3% (30/114; revised Spielberger State-Trait Anxiety Inventory questionnaire) of the patients before the biopsy and 9.0% (10/114) after the biopsy for all patients, without a significant difference between the 2 groups (P=.83). Immersion in VR was well tolerated by the majority (54/57, 95%) of patients in the VR group. ConclusionsThe intensity of pain did not significantly differ between both arms. VR was well tolerated, and the satisfaction of patients, nurses, and physicians was very high. VR could be an alternative treatment in case of contraindication or intolerance to MEOPA. Trial RegistrationClinicalTrials.gov NCT03483194; https://clinicaltrials.gov/ct2/show/NCT03483194https://www.jmir.org/2023/1/e38619 |
| spellingShingle | Katell Le Du Anne-Lise Septans Frédéric Maloisel Hélène Vanquaethem Anna Schmitt Marielle Le Goff Aline Clavert Marie Zinger Hugues Bourgeois Olivier Dupuis Fabrice Denis Stéphane Bouchard A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study Journal of Medical Internet Research |
| title | A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study |
| title_full | A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study |
| title_fullStr | A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study |
| title_full_unstemmed | A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study |
| title_short | A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study |
| title_sort | new option for pain prevention using a therapeutic virtual reality solution for bone marrow biopsy reveh trial open label randomized multicenter phase 3 study |
| url | https://www.jmir.org/2023/1/e38619 |
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