Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

152

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Guangdong
      • Guangzhou, Guangdong, Chine, 510120
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Control Group (Routine imaging care only)
Patients receive standard routine imaging care without any additional music or aromatherapy interventions. Standard vital sign monitoring is conducted for 20 minutes before MRI and maintained throughout the whole scan procedure.
Expérimental: MT Group (Guzheng music intervention)
On the basis of routine imaging care, patients receive 20 minutes of autonomic monitoring before MRI. After 10 minutes of baseline monitoring, participants listen to the guzheng piece Fishing Boat Singing at Dusk via MRI-compatible headphones; autonomic monitoring continues until scan completion.
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.
Expérimental: AT Group (Lavender aromatherapy intervention)
Patients complete 20 minutes of autonomic monitoring prior to MRI examination. After 10 minutes of baseline monitoring, 2 drops of Lavandula angustifolia essential oil are applied to an absorbent pad fixed on the patient's collar. Subjects breathe normally, and autonomic monitoring lasts through the entire MRI scan.
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.
Expérimental: Combined MT+AT Group (Music plus aromatherapy)
Patients receive both interventions simultaneously during 20-minute pre-MRI autonomic monitoring. Two drops of lavender essential oil are placed on the collar pad, while participants listen to the guzheng piece via MRI-safe headphones. Both sensory stimuli and autonomic monitoring persist for the full duration of MRI scanning.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Hospital Anxiety and Depression Scale anxiety subscale score
Délai: Baseline (pre-MRI) and within 30 minutes immediately after completion of MRI examination
Difference 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.
Baseline (pre-MRI) and within 30 minutes immediately after completion of MRI examination

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in low-frequency heart rate variability parameter
Délai: Baseline (pre-MRI), during MRI scanning, and within 30 minutes immediately after completion of MRI examination
Heart 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.
Baseline (pre-MRI), during MRI scanning, and within 30 minutes immediately after completion of MRI examination
Change in high-frequency heart rate variability parameter
Délai: Baseline (pre-MRI), during MRI scanning, and within 30 minutes immediately after completion of MRI examination
Heart 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.
Baseline (pre-MRI), during MRI scanning, and within 30 minutes immediately after completion of MRI examination
Standardized amplitude of low-frequency fluctuations from resting-state functional MRI
Délai: Within 30 minutes after completion of clinical MRI scan and assigned study intervention
Whole-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.
Within 30 minutes after completion of clinical MRI scan and assigned study intervention
Standardized z-score degree centrality from resting-state functional MRI
Délai: Within 30 minutes after completion of clinical MRI scan and assigned study intervention
Whole-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.
Within 30 minutes after completion of clinical MRI scan and assigned study intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 avril 2025

Achèvement primaire (Réel)

9 avril 2026

Achèvement de l'étude (Réel)

10 avril 2026

Dates d'inscription aux études

Première soumission

28 juin 2026

Première soumission répondant aux critères de contrôle qualité

2 juillet 2026

Première publication (Réel)

9 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juillet 2026

Dernière vérification

1 avril 2025

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SKSY-2024-480-03

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data (IPD) will not be shared externally to protect participants' privacy and comply with institutional ethical review board requirements. Raw MRI, HRV and questionnaire records contain identifiable sensitive clinical information, and relevant local privacy regulations prohibit the public release of individual-level raw data.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner