{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T18:41:42Z","timestamp":1764096102924,"version":"3.46.0"},"reference-count":33,"publisher":"Public Library of Science (PLoS)","issue":"11","license":[{"start":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T00:00:00Z","timestamp":1764028800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Botulinum toxin injections are a common treatment for managing spasticity resulting from central nervous system damage, including stroke, multiple sclerosis, and traumatic brain injury. However, the injections are associated with perceived pain, and many patients experience significant anticipatory stress regarding future sessions. The intensity of this stress varies among individuals. Music therapy, particularly receptive musical interventions structured around a U-shaped sequence, promotes progressive relaxation through distinct musical phases. This method has demonstrated efficacy in reducing pain and anxiety across various clinical contexts, including chronic and acute pain, Alzheimer\u2019s disease, fibromyalgia, and neurologically mediated pain. Given the painful nature of botulinum toxin injections, this study proposes the use of receptive music therapy to improve patient tolerance of the procedure. We hypothesize that receptive musical intervention can reduce injection-induced stress in adults undergoing botulinum toxin treatment. To our knowledge, no studies have specifically investigated the effect of music therapy on stress related to botulinum toxin injections. We aim to conduct a prospective randomized (1:1) controlled trial to evaluate the impact of receptive music intervention on stress levels, measured via heart rate variability (HRV), during botulinum toxin injection sessions. The primary objective is to assess the effect of receptive musical intervention during botulinum toxin injections on injection-induced stress, measured by HRV. Secondary objectives include evaluating the intervention\u2019s effects on pain intensity and anxiety levels.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Patient satisfaction following the music-assisted injection session will also be assessed. Additionally, the physician\u2019s evaluation of the procedure and the patient\u2019s perception of time during the session will be recorded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>All participants will provide written informed consent prior to enrollment. The study has received approval from the relevant institutional ethics committee (Comit\u00e9 de Protection des Personnes \u2013 ID: 25.00156.000468, Sud-M\u00e9diterran\u00e9e IV, approved on 3 April 2025). Findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT06920524\" xlink:type=\"simple\">NCT06920524<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0327259","type":"journal-article","created":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T18:29:32Z","timestamp":1764095372000},"page":"e0327259","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Musical intervention to reduce stress during botulinum toxin injection for spasticity: Protocol for a randomized controlled trial (MUSIBOT)"],"prefix":"10.1371","volume":"20","author":[{"given":"Pierre","family":"Angelvy","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marina","family":"Badin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4340-0069","authenticated-orcid":true,"given":"Mathilde","family":"Pelletier-Visa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pascale","family":"Givron","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3778-7161","authenticated-orcid":true,"given":"Bruno","family":"Pereira","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuel","family":"Coudeyre","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,11,25]]},"reference":[{"issue":"2","key":"pone.0327259.ref001","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1007\/s40265-018-1042-z","article-title":"Botulinum Toxin Type A for the Treatment of Lower Limb Spasticity after Stroke","volume":"79","author":"A Santamato","year":"2019","journal-title":"Drugs"},{"key":"pone.0327259.ref002","unstructured":"sofmer_Reco-Spasticite.pdf. Consult\u00e9 le: 3 juin 2025. [En ligne]. Disponible sur: https:\/\/www.sofmer.com\/download\/sofmer_Reco-Spasticite.pdf"},{"issue":"4","key":"pone.0327259.ref003","doi-asserted-by":"crossref","first-page":"283","DOI":"10.1016\/j.rehab.2018.06.010","article-title":"Adjunct therapies to improve outcomes after botulinum toxin injection in children: A systematic review","volume":"62","author":"L Mathevon","year":"2019","journal-title":"Ann Phys Rehabil Med"},{"key":"pone.0327259.ref004","unstructured":"Integrating Physical Therapy and Exercise in Mental Health: A Novel Framework for Suicide Prevention and Depression Management | Auctores. Consult\u00e9 le: 12 septembre 2025. [En ligne]. Disponible sur: https:\/\/auctoresonline.org\/article\/integrating-physical-therapy-and-exercise-in-mental-health-a-novel-framework-for-suicide-prevention-and-depression-management"},{"issue":"2","key":"pone.0327259.ref005","doi-asserted-by":"crossref","first-page":"322","DOI":"10.1016\/j.ijcard.2012.04.141","article-title":"JOBSTRESS study: comparison of heart rate variability in emergency physicians working a 24-hour shift or a 14-hour night shift--a randomized trial","volume":"158","author":"F Dutheil","year":"2012","journal-title":"Int J Cardiol"},{"issue":"5","key":"pone.0327259.ref006","doi-asserted-by":"crossref","first-page":"1043","DOI":"10.1161\/01.CIR.93.5.1043","article-title":"Heart rate variability: standards of measurement, physiological interpretation and clinical use","volume":"93","author":"Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology","year":"1996","journal-title":"Circulation"},{"issue":"3","key":"pone.0327259.ref007","doi-asserted-by":"crossref","first-page":"235","DOI":"10.30773\/pi.2017.08.17","article-title":"Stress and Heart Rate Variability: A Meta-Analysis and Review of the Literature","volume":"15","author":"H-G Kim","year":"2018","journal-title":"Psychiatry Investig"},{"issue":"5","key":"pone.0327259.ref008","doi-asserted-by":"crossref","first-page":"791","DOI":"10.1109\/TFUZZ.2006.889825","article-title":"Fuzzy Evaluation of Heart Rate Signals for Mental Stress Assessment","volume":"15","author":"M Kumar","year":"2007","journal-title":"IEEE Trans Fuzzy Syst"},{"key":"pone.0327259.ref009","first-page":"2781","article-title":"Application of wavelet analysis to the plethysmogram for the evaluation of mental stress","volume":"2005","author":"K Yashima","year":"2005","journal-title":"Conf Proc IEEE Eng Med Biol Soc"},{"issue":"6","key":"pone.0327259.ref010","doi-asserted-by":"crossref","first-page":"215","DOI":"10.2114\/jpa.23.215","article-title":"Cardiovascular reactivity to mental stress: relationship with menstrual cycle and gender","volume":"23","author":"N Sato","year":"2004","journal-title":"J Physiol Anthropol Appl Human Sci"},{"issue":"3","key":"pone.0327259.ref011","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1080\/10803548.2008.11076767","article-title":"Perceived mental stress and reactions in heart rate variability--a pilot study among employees of an electronics company","volume":"14","author":"R Orsila","year":"2008","journal-title":"Int J Occup Saf Ergon"},{"issue":"1","key":"pone.0327259.ref012","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1186\/1475-925X-10-96","article-title":"Nonlinear Heart Rate Variability features for real-life stress detection. Case study: students under stress due to university examination","volume":"10","author":"P Melillo","year":"2011","journal-title":"BioMed Eng OnLine"},{"issue":"6","key":"pone.0327259.ref013","doi-asserted-by":"crossref","first-page":"731","DOI":"10.1001\/jama.283.6.731-JMN0209-2-1","article-title":"Music Therapists Chime In With Data on Medical Results","volume":"283","author":"C Marwick","year":"2000","journal-title":"JAMA"},{"issue":"5","key":"pone.0327259.ref014","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1159\/000319529","article-title":"Receptive music therapy for the treatment of depression: a proof-of-concept study and prospective controlled clinical trial of efficacy","volume":"79","author":"V Brandes","year":"2010","journal-title":"Psychother Psychosom"},{"issue":"02","key":"pone.0327259.ref015","doi-asserted-by":"crossref","first-page":"67","DOI":"10.2310\/7200.2006.002","article-title":"Effects of Music and Music Therapy on Medical Patients: A Meta-Analysis of the Research and Implications for the Future","volume":"04","author":"C Dileo","year":"2006","journal-title":"J Soc Integr Oncol"},{"issue":"4","key":"pone.0327259.ref016","doi-asserted-by":"crossref","first-page":"430","DOI":"10.1093\/jmt\/thw012","article-title":"The Effects of Music on Pain: A Meta-Analysis","volume":"53","author":"JH Lee","year":"2016","journal-title":"J Music Ther"},{"key":"pone.0327259.ref017","doi-asserted-by":"crossref","first-page":"727","DOI":"10.2147\/PPA.S61340","article-title":"Effectiveness of music therapy: a summary of systematic reviews based on randomized controlled trials of music interventions","volume":"8","author":"H Kamioka","year":"2014","journal-title":"Patient Prefer Adherence"},{"issue":"4","key":"pone.0327259.ref018","doi-asserted-by":"crossref","first-page":"780","DOI":"10.1016\/j.aorn.2007.09.013","article-title":"The anxiety- and pain-reducing effects of music interventions: a systematic review","volume":"87","author":"U Nilsson","year":"2008","journal-title":"AORN J"},{"key":"pone.0327259.ref019","article-title":"Musique et douleur\u00a0: la s\u00e9quence en \u00a0U, une solution th\u00e9rapeutique standardis\u00e9e et valid\u00e9e","author":"S Gu\u00e9tin","year":"2017","journal-title":"Douleur Analg"},{"issue":"4","key":"pone.0327259.ref020","doi-asserted-by":"crossref","first-page":"329","DOI":"10.1097\/AJP.0b013e31822be973","article-title":"The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial","volume":"28","author":"S Gu\u00e9tin","year":"2012","journal-title":"Clin J Pain"},{"issue":"9","key":"pone.0327259.ref021","doi-asserted-by":"crossref","first-page":"1007","DOI":"10.1001\/jamaophthalmol.2021.2767","article-title":"Efficacy of a Web App-Based Music Intervention During Cataract Surgery: A Randomized Clinical Trial","volume":"139","author":"G Guerrier","year":"2021","journal-title":"JAMA Ophthalmol"},{"key":"pone.0327259.ref022","doi-asserted-by":"crossref","first-page":"100126","DOI":"10.1016\/j.pcorm.2020.100126","article-title":"Musical intervention reduces anxiety-related hypertensive events during cataract surgery: A randomized controlled trial","volume":"20","author":"G Guerrier","year":"2020","journal-title":"Perioper Care Oper Room Manag"},{"key":"pone.0327259.ref023","doi-asserted-by":"crossref","first-page":"102779","DOI":"10.1016\/j.ctim.2021.102779","article-title":"Smartphone based music intervention in the treatment of episodic migraine headaches - A pilot trial","volume":"63","author":"G Parlongue","year":"2021","journal-title":"Complement Ther Med"},{"issue":"4","key":"pone.0327259.ref024","first-page":"60","article-title":"Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences","volume":"22","author":"S Gu\u00e9tin","year":"2016","journal-title":"Altern Ther Health Med"},{"issue":"3","key":"pone.0327259.ref025","doi-asserted-by":"crossref","first-page":"307","DOI":"10.4103\/0973-1075.185042","article-title":"Effect of Music Therapy on Pain and Anxiety Levels of Cancer Patients: A Pilot Study","volume":"22","author":"P Krishnaswamy","year":"2016","journal-title":"Indian J Palliat Care"},{"issue":"10","key":"pone.0327259.ref026","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2022-066726","article-title":"Use of immersive virtual reality for stress reduction during botulinum toxin injection for spasticity (RVTOX): a study protocol of a randomised control trial","volume":"13","author":"M Bougeard","year":"2023","journal-title":"BMJ Open"},{"issue":"6","key":"pone.0327259.ref027","doi-asserted-by":"crossref","first-page":"1784","DOI":"10.1038\/s41591-025-03668-w","article-title":"SPIRIT 2025 statement: updated guideline for protocols of randomized trials","volume":"31","author":"A-W Chan","year":"2025","journal-title":"Nat Med"},{"issue":"1","key":"pone.0327259.ref028","doi-asserted-by":"crossref","first-page":"40","DOI":"10.7326\/M17-0046","article-title":"CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts","volume":"167","author":"CONSORT NPT Group","year":"2017","journal-title":"Ann Intern Med"},{"issue":"3","key":"pone.0327259.ref029","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1097\/NPT.0000000000000133","article-title":"Using the TIDieR Checklist to Standardize the Description of a Functional Strength Training Intervention for the Upper Limb After Stroke","volume":"40","author":"P van Vliet","year":"2016","journal-title":"J Neurol Phys Ther"},{"issue":"1","key":"pone.0327259.ref030","doi-asserted-by":"crossref","first-page":"11112","DOI":"10.1038\/s41598-020-68008-z","article-title":"Trait and state anxiety are mapped differently in the human brain","volume":"10","author":"F Saviola","year":"2020","journal-title":"Sci Rep"},{"issue":"1","key":"pone.0327259.ref031","doi-asserted-by":"crossref","first-page":"1","DOI":"10.2478\/acm-2021-0001","article-title":"The Effect of Music on Heart Rate Variability (Review)","volume":"21","author":"D Parizek","year":"2021","journal-title":"Acta Medica Martiniana"},{"key":"pone.0327259.ref032","first-page":"100072","article-title":"Temporal patterns of suicide attempts in India: A Comprehensive analysis by time of day, week, and hour, stratified by age, sex, and marital status, and examining suicidal methods distribution","volume":"7","author":"J Kanani","year":"2024","journal-title":"Brain Behav Immun Integr"},{"issue":"2","key":"pone.0327259.ref033","doi-asserted-by":"crossref","DOI":"10.1111\/j.1083-6101.1997.tb00072.x","article-title":"At the Heart of It All: The Concept of Presence","volume":"3","author":"M Lombard","year":"2006","journal-title":"J Comput Mediat Commun"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0327259","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T18:29:37Z","timestamp":1764095377000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0327259"}},"subtitle":[],"editor":[{"given":"Maheshkumar","family":"Baladaniya","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,11,25]]},"references-count":33,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2025,11,25]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0327259","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,25]]}}}