Multisensory Interventions Reduce MRI Anxiety in Cancer Patients

NCT07692412 | Completed

• 1 other identifier: SKSY-2024-480-03
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Tumor (Cancer); MRI Examination-induced Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Hospital Anxiety and Depression Scale anxiety subscale score

  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

Secondary Outcomes (4)

• Change in low-frequency heart rate variability parameter

  Baseline (pre-MRI), during MRI scanning, and within 30 minutes immediately after completion of MRI examination

• Change in high-frequency heart rate variability parameter

  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

  Within 30 minutes after completion of clinical MRI scan and assigned study intervention

• Standardized z-score degree centrality from resting-state functional MRI

  Within 30 minutes after completion of clinical MRI scan and assigned study intervention

Study Arms (4)

Control Group (Routine imaging care only)

NO INTERVENTION

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.

MT Group (Guzheng music intervention)

EXPERIMENTAL

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.

Behavioral: Guzheng music therapy

AT Group (Lavender aromatherapy intervention)

EXPERIMENTAL

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.

Behavioral: Lavender aromatherapy

Combined MT+AT Group (Music plus aromatherapy)

EXPERIMENTAL

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.

Behavioral: Guzheng music therapy; Behavioral: Lavender aromatherapy

Interventions

Guzheng music therapy BEHAVIORAL

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.

Combined MT+AT Group (Music plus aromatherapy); MT Group (Guzheng music intervention)

Lavender aromatherapy BEHAVIORAL

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.

AT Group (Lavender aromatherapy intervention); Combined MT+AT Group (Music plus aromatherapy)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (17)

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MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 9, 2026
• Study Start: April 10, 2025
• Primary Completion: April 9, 2026
• Study Completion: April 10, 2026
• Last Updated: July 9, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)