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Multisensory Interventions Reduce MRI Anxiety in Cancer Patients

Multisensory Therapy Alleviating MRI-Related Anxiety in Cancer Patients Via Brain-Autonomic Network Modulation: A Randomized Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07692412
Enrollment
152
Registered
2026-07-09
Start date
2025-04-10
Completion date
2026-04-10
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumor (Cancer), MRI Examination-induced Anxiety

Brief summary

MRI-related anxiety is prevalent among cancer patients and frequently undermines imaging quality by inducing motion artifacts or causing premature examination termination. Safe, non-pharmacological supportive interventions have the potential to alleviate procedural anxiety, yet the underlying neurobiological mechanisms remain unclear. This study aimed to investigate the anxiolytic effect of a combined multisensory intervention integrating music therapy and aromatherapy during MRI procedures, and to further explore its potential neurophysiological mechanisms via autonomic nervous system monitoring and resting-state functional magnetic resonance imaging (rs-fMRI). This study adopted a prospective, single-center, parallel-group randomized controlled trial design and was conducted at Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, between April 2025 and April 2026. Eligible participants were randomly allocated to four groups in equal proportions to receive routine care, music therapy alone, aromatherapy alone, or combined music and aromatherapy interventions. All study interventions were delivered consistently throughout the pre-MRI waiting period and the formal MRI scanning procedure, while participants in the control group received only standard clinical care without additional supportive intervention.

Detailed description

Cancer patients frequently experience significant anxiety during MRI examinations. The confined scanning environment, persistent acoustic noise, and mandatory prolonged immobilization inherent to MRI protocols collectively induce intense procedural stress. Such anxiety commonly causes motion artifacts, impairs diagnostic image quality, and may lead to premature scan termination. Beyond compromising imaging efficiency and accuracy, MRI-triggered psychological distress aggravates the overall psychological burden of cancer 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 and peripheral autonomic regulatory systems. Chronic stress in oncological populations hyperactivates sympathetic tone and the hypothalamic-pituitary-adrenal axis, driving neuroendocrine dysfunction and immunosuppression. Multiple core brain networks, including the default mode, salience, and executive control networks, govern anxiety processing, with disrupted functional connectivity closely linked to anxiety severity. Concurrent HRV and neuroimaging research further confirms that acute MRI stress distorts bidirectional communication between cortical emotional regulatory regions and subcortical autonomic control centers. Complementary interventions have emerged as safe, scalable strategies for mitigating cancer-related psychological distress. The 2023 joint clinical guidelines from the Society for Integrative Oncology and the American Society of Clinical Oncology endorse music therapy and aromatherapy for relieving cancer-associated anxiety. Each modality exerts independent anxiolytic effects via distinct neural and physiological pathways. Preliminary clinical evidence suggests that combined auditory and olfactory multisensory interventions may yield superior anxiolytic outcomes compared with single-modality approaches during stressful medical procedures. Current literature lacks systematic evidence regarding the synergistic neurobiological mechanisms of combined music and aromatherapy for MRI-specific anxiety in cancer patients. Existing studies predominantly rely on subjective psychological assessments without synchronized objective autonomic and brain network profiling. This prospective randomized controlled trial addresses these research gaps by adopting a multi-dimensional evaluation system to characterize the behavioral, physiological, and neural effects of integrated multisensory intervention, aiming to provide mechanistic evidence for standardized supportive care protocols in oncological imaging practice. This prospective, single-center, four-arm parallel-group randomized controlled trial was conducted at Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, from April 2025 to April 2026. The study protocol was ethically approved (SKSY-2024-480-03), implemented in strict accordance with the Declaration of Helsinki and CONSORT 2025 guidelines, and pre-registered in the National Medical Research Registration and Information System of China (MR-44-25-034307). All participants provided written informed consent prior to enrollment. This study enrolled eligible adult oncology patients requiring routine clinical MRI examinations, with unified enrollment specifications formulated to ensure homogeneous study populations. Standardized exclusion criteria were established to exclude populations that might compromise intervention safety, data authenticity and research credibility. Eligible participants were equally randomized into four parallel groups (1:1:1:1 allocation): routine care control, single music therapy, single aromatherapy, and combined multisensory intervention. Randomization was performed via computer-generated random numbers with sealed opaque envelopes by an independent researcher blinded to recruitment, 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 remained fully blinded to group allocation throughout the trial to minimize detection bias. All intervention protocols were initiated during the pre-scan waiting phase and sustained continuously throughout the entire MRI scanning procedure. Control Group: Participants received standard clinical MRI care and routine pre-scan guidance without additional supportive interventions, with continuous vital sign monitoring throughout the procedure. Music Therapy Group: Based on standard care, participants received standardized pre-scan autonomic monitoring followed by continuous exposure to a validated soothing traditional Chinese pentatonic guzheng musical stimulus via MRI-compatible headphones throughout scanning. Aromatherapy Group: With consistent pre-scan autonomic monitoring, participants received standardized lavender olfactory stimulation via a fixed collar absorbent pad during the entire MRI procedure, with natural breathing maintained throughout. Combined MT + AT Group: Participants received synchronized music and aromatherapy multisensory stimulation, with both interventions initiated after baseline physiological stabilization and sustained across the full scanning process. The selected musical stimulus features high melodic consonance and smooth pentatonic structure to avoid triggering physiological alert responses. Lavender essential oil was selected based on robust meta-analytic evidence for reliable anxiolytic efficacy, with its core volatile components modulating central nervous system activity via olfactory transduction pathways.

Interventions

BEHAVIORALGuzheng music therapy

Patients listen to the traditional Chinese guzheng piece Fishing Boat Singing at Dusk via MRI-compatible noise-isolating headphones continuously during MRI scanning. The music intervention starts after 10 minutes of baseline autonomic monitoring within the 20-minute pre-examination monitoring window.

Two drops of pure Lavandula angustifolia essential oil are dripped onto an absorbent pad fixed to the patient's collar near the neck before MRI. Patients breathe normally to receive sustained lavender aroma stimulation throughout the entire scan, initiated after 10 minutes of baseline autonomic monitoring.

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Aged 18 to 60 years * Pathologically confirmed malignant tumor * Require clinically indicated MRI examination * Baseline HADS anxiety subscale score ≥ 8 * Able to understand study procedures and provide written informed consent

Exclusion criteria

* Severe cognitive impairment or preexisting neurological disorders that compromise neuroimaging data quality * Confirmed olfactory or auditory dysfunction * Known hypersensitivity to aromatic essential oils * MRI contraindications (implanted metallic devices, severe claustrophobia) or unstable cardiovascular conditions * Concurrent enrollment in other interventional clinical trials

Design outcomes

Primary

MeasureTime frameDescription
Change in Hospital Anxiety and Depression Scale anxiety subscale scoreBaseline (pre-MRI) and within 30 minutes immediately after completion of MRI examinationDifference in anxiety severity quantified using the full Hospital Anxiety and Depression Scale (HADS) anxiety subscale. The subscale ranges from 0 (minimum, no anxiety symptoms) to 21 (maximum, severe anxiety); higher scores correspond to worse anxiety status. Anxiety scores are captured at two distinct time points to compute the pre-to-post MRI score change.

Secondary

MeasureTime frameDescription
Change in low-frequency heart rate variability parameterBaseline (pre-MRI), during MRI scanning, and within 30 minutes immediately after completion of MRI examinationHeart rate variability low-frequency (LF) index derived from continuous 3-lead electrocardiography signals, which quantifies sympathetic nervous system activity. Delta LF values calculated relative to pre-MRI baseline will be compared between study groups.
Change in high-frequency heart rate variability parameterBaseline (pre-MRI), during MRI scanning, and within 30 minutes immediately after completion of MRI examinationHeart rate variability high-frequency (HF) index derived from continuous 3-lead electrocardiography signals, which quantifies parasympathetic nervous system activity. Delta HF values calculated relative to pre-MRI baseline will be compared between study groups.
Standardized amplitude of low-frequency fluctuations from resting-state functional MRIWithin 30 minutes after completion of clinical MRI scan and assigned study interventionWhole-brain standardized amplitude of low-frequency fluctuations (zALFF) derived from 10-minute rs-fMRI. Uniform preprocessing pipelines are applied to compute this metric for intergroup comparison of spontaneous regional brain neural activity.
Standardized z-score degree centrality from resting-state functional MRIWithin 30 minutes after completion of clinical MRI scan and assigned study interventionWhole-brain standardized z-score degree centrality (szDC) derived from 10-minute rs-fMRI. Uniform preprocessing pipelines are applied to compute this metric for intergroup comparison of whole-brain functional connectivity strength.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026