Authors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
Cancer patients frequently experience significant anxiety during MRI examinations. Theconfined scanning environment, persistent acoustic noise, and mandatory prolongedimmobilization inherent to MRI protocols collectively induce intense procedural stress.Such anxiety commonly causes motion artifacts, impairs diagnostic image quality, and maylead to premature scan termination. Beyond compromising imaging efficiency and accuracy,MRI‐triggered psychological distress aggravates the overall psychological burden ofcancer patients and may perturb systemic neuroendocrine and immune homeostasis,potentially affecting long‐term disease prognosis.Procedural anxiety arises from dynamic crosstalk between central neural circuits andperipheral autonomic regulatory systems. Chronic stress in oncological populationshyperactivates sympathetic tone and the hypothalamic‐pituitary‐adrenal axis, drivingneuroendocrine dysfunction and immunosuppression. Multiple core brain networks, includingthe default mode, salience, and executive control networks, govern anxiety processing,with disrupted functional connectivity closely linked to anxiety severity. Concurrent HRVand neuroimaging research further confirms that acute MRI stress distorts bidirectionalcommunication between cortical emotional regulatory regions and subcortical autonomiccontrol centers.Complementary interventions have emerged as safe, scalable strategies for mitigatingcancer‐related psychological distress. The 2023 joint clinical guidelines from theSociety for Integrative Oncology and the American Society of Clinical Oncology endorsemusic therapy and aromatherapy for relieving cancer‐associated anxiety. Each modalityexerts independent anxiolytic effects via distinct neural and physiological pathways.Preliminary clinical evidence suggests that combined auditory and olfactory multisensoryinterventions may yield superior anxiolytic outcomes compared with single‐modalityapproaches during stressful medical procedures.Current literature lacks systematic evidence regarding the synergistic neurobiologicalmechanisms of combined music and aromatherapy for MRI‐specific anxiety in cancerpatients. Existing studies predominantly rely on subjective psychological assessmentswithout synchronized objective autonomic and brain network profiling. This prospectiverandomized controlled trial addresses these research gaps by adopting a multi‐dimensionalevaluation system to characterize the behavioral, physiological, and neural effects ofintegrated multisensory intervention, aiming to provide mechanistic evidence forstandardized supportive care protocols in oncological imaging practice.This prospective, single‐center, four‐arm parallel‐group randomized controlled trial wasconducted at Sun Yat‐Sen Memorial Hospital, Sun Yat‐Sen University, from April 2025 toApril 2026. The study protocol was ethically approved (SKSY‐2024‐480‐03), implemented instrict accordance with the Declaration of Helsinki and CONSORT 2025 guidelines, andpre‐registered in the National Medical Research Registration and Information System ofChina (MR‐44‐25‐034307). All participants provided written informed consent prior toenrollment.This study enrolled eligible adult oncology patients requiring routine clinical MRIexaminations, with unified enrollment specifications formulated to ensure homogeneousstudy populations.Standardized exclusion criteria were established to exclude populations that mightcompromise intervention safety, data authenticity and research credibility.Eligible participants were equally randomized into four parallel groups (1:1:1:1allocation): routine care control, single music therapy, single aromatherapy, andcombined multisensory intervention. Randomization was performed via computer‐generatedrandom numbers with sealed opaque envelopes by an independent researcher blinded torecruitment, intervention delivery, and outcome evaluation.Due to the sensory nature of the interventions, participant blinding was not achievable.However, all data analysts, neuroimaging processors, and clinical radiologists remainedfully blinded to group allocation throughout the trial to minimize detection bias.All intervention protocols were initiated during the pre‐scan waiting phase and sustainedcontinuously throughout the entire MRI scanning procedure.Control Group: Participants received standard clinical MRI care and routine pre‐scanguidance without additional supportive interventions, with continuous vital signmonitoring throughout the procedure.Music Therapy Group: Based on standard care, participants received standardized pre‐scanautonomic monitoring followed by continuous exposure to a validated soothing traditionalChinese pentatonic guzheng musical stimulus via MRI‐compatible headphones throughoutscanning.Aromatherapy Group: With consistent pre‐scan autonomic monitoring, participants receivedstandardized lavender olfactory stimulation via a fixed collar absorbent pad during theentire MRI procedure, with natural breathing maintained throughout.Combined MT + AT Group: Participants received synchronized music and aromatherapymultisensory stimulation, with both interventions initiated after baseline physiologicalstabilization and sustained across the full scanning process.The selected musical stimulus features high melodic consonance and smooth pentatonicstructure to avoid triggering physiological alert responses. Lavender essential oil wasselected based on robust meta‐analytic evidence for reliable anxiolytic efficacy, withits core volatile components modulating central nervous system activity via olfactorytransduction pathways.
Epistemonikos ID: b1a13d8b5bd80cc83c8e74bfbb1a78ba6b545e9b
First added on: Jul 10, 2026