Malignant Tumor (Cancer)NCT07692412
Multisensory Interventions Reduce MRI Anxiety in Cancer Patients
A study testing Guzheng music therapy and Lavender aromatherapy in people with Malignant Tumor (Cancer) and MRI Examination-induced Anxiety, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Malignant Tumor (Cancer), MRI Examination-induced Anxiety
- What is being tested?
- Guzheng music therapy and Lavender aromatherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
About this study
Official title: 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.
Read the 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.
- Being tested
- Guzheng music therapy, Lavender aromatherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guzheng music therapyBehavioural
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.
Lavender aromatherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Guzheng music therapy; Behavioral: Lavender aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-MRI) and within 30 minutes immediately after completion of MRI examination
Secondary outcomes (4)
Change in low-frequency heart rate variability parameter
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.
Measured: Baseline (pre-MRI), during MRI scanning, and within 30 minutes immediately after completion of MRI examination
Change in high-frequency heart rate variability parameter
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.
Measured: 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
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.
Measured: Within 30 minutes after completion of clinical MRI scan and assigned study intervention
Standardized z-score degree centrality from resting-state functional MRI
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.
Measured: Within 30 minutes after completion of clinical MRI scan and assigned study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start10 Apr 2025
- Primary completion9 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Malignant Tumor (Cancer)Studies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692412
- Sponsor's protocol ID
- SKSY-2024-480-03
- Status last verified
- Apr 2025
- First submitted
- 28 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Wen X, Shi J, Tan W, Jiang H, Wang D, Su J, Yang G, Zhang B. Effects of aromatherapy and music therapy on patients' anxiety during MRI examinations: a randomized controlled trial. Eur Radiol. 2023 Apr;33(4):2510-2518. doi: 10.1007/s00330-022-09230-3. Epub 2022 Nov 6.
PubMed 36335480Yoo O, Park SA. Anxiety-Reducing Effects of Lavender Essential Oil Inhalation: A Systematic Review. Healthcare (Basel). 2023 Nov 17;11(22):2978. doi: 10.3390/healthcare11222978.
PubMed 37998470Tan L, Liao FF, Long LZ, Ma XC, Peng YX, Lu JM, Qu H, Fu CG. Essential oils for treating anxiety: a systematic review of randomized controlled trials and network meta-analysis. Front Public Health. 2023 Jun 1;11:1144404. doi: 10.3389/fpubh.2023.1144404. eCollection 2023.
PubMed 37325306Sun C, Fei C, Lin R, Qiu X, Wang W, Jiang X, Sun F, Wang Y, Tang L. The Efficacy of Aromatherapy on Pain and Anxiety During Needle-Related Procedures in Adults: A Systematic Review and Meta-Analysis. J Pain Res. 2025 Aug 13;18:4053-4072. doi: 10.2147/JPR.S533076. eCollection 2025.
PubMed 40827258de Witte M, Aalbers S, Vink A, Friederichs S, Knapen A, Pelgrim T, Lampit A, Baker FA, van Hooren S. Music therapy for the treatment of anxiety: a systematic review with multilevel meta-analyses. EClinicalMedicine. 2025 Jun 9;84:103293. doi: 10.1016/j.eclinm.2025.103293. eCollection 2025 Jun.
PubMed 40547443Yang HF, Chang WW, Chou YH, Huang JY, Liao YS, Liao TE, Tseng HC, Chang ST, Chen HL, Ke YF, Tsai PF, Chan HM, Chang BJ, Hwang YT, Tsai HY, Lee YC. Impact of background music listening on anxiety in cancer patients undergoing initial radiation therapy: a randomized clinical trial. Radiat Oncol. 2024 Jun 11;19(1):73. doi: 10.1186/s13014-024-02460-3.
PubMed 38862982Xiao X, Chen W, Zhang X. The effect and mechanisms of music therapy on the autonomic nervous system and brain networks of patients of minimal conscious states: a randomized controlled trial. Front Neurosci. 2023 May 12;17:1182181. doi: 10.3389/fnins.2023.1182181. eCollection 2023.
PubMed 37250411Carlson LE, Ismaila N, Addington EL, Asher GN, Atreya C, Balneaves LG, Bradt J, Fuller-Shavel N, Goodman J, Hoffman CJ, Huston A, Mehta A, Paller CJ, Richardson K, Seely D, Siwik CJ, Temel JS, Rowland JH. Integrative Oncology Care of Symptoms of Anxiety and Depression in Adults With Cancer: Society for Integrative Oncology-ASCO Guideline. J Clin Oncol. 2023 Oct 1;41(28):4562-4591. doi: 10.1200/JCO.23.00857. Epub 2023 Aug 15.
PubMed 37582238Mao JJ, Ismaila N, Bao T, Barton D, Ben-Arye E, Garland EL, Greenlee H, Leblanc T, Lee RT, Lopez AM, Loprinzi C, Lyman GH, MacLeod J, Master VA, Ramchandran K, Wagner LI, Walker EM, Bruner DW, Witt CM, Bruera E. Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology-ASCO Guideline. J Clin Oncol. 2022 Dec 1;40(34):3998-4024. doi: 10.1200/JCO.22.01357. Epub 2022 Sep 19.
PubMed 36122322Matusik PS, Zhong C, Matusik PT, Alomar O, Stein PK. Neuroimaging Studies of the Neural Correlates of Heart Rate Variability: A Systematic Review. J Clin Med. 2023 Jan 28;12(3):1016. doi: 10.3390/jcm12031016.
PubMed 36769662Huber A, Koenig J, Bruns B, Bendszus M, Friederich HC, Simon JJ. Brain activation and heart rate variability as markers of autonomic function under stress. Sci Rep. 2025 Aug 1;15(1):28114. doi: 10.1038/s41598-025-12430-8.
PubMed 40751053Zugman A, Jett L, Antonacci C, Winkler AM, Pine DS. A systematic review and meta-analysis of resting-state fMRI in anxiety disorders: Need for data sharing to move the field forward. J Anxiety Disord. 2023 Oct;99:102773. doi: 10.1016/j.janxdis.2023.102773. Epub 2023 Sep 15.
PubMed 37741177Grogans SE, Bliss-Moreau E, Buss KA, Clark LA, Fox AS, Keltner D, Cowen AS, Kim JJ, Kragel PA, MacLeod C, Mobbs D, Naragon-Gainey K, Fullana MA, Shackman AJ. The nature and neurobiology of fear and anxiety: State of the science and opportunities for accelerating discovery. Neurosci Biobehav Rev. 2023 Aug;151:105237. doi: 10.1016/j.neubiorev.2023.105237. Epub 2023 May 18.
PubMed 37209932Ma Y, Kroemer G. The cancer-immune dialogue in the context of stress. Nat Rev Immunol. 2024 Apr;24(4):264-281. doi: 10.1038/s41577-023-00949-8. Epub 2023 Oct 13.
PubMed 37833492Masalma R, Zidan T, Amasheh S, Maree M, Alhanbali M, Shawahna R. Predictors of anxiety in patients undergoing magnetic resonance imaging scans: a multicenter cross-sectional study. BMC Psychiatry. 2024 Sep 27;24(1):633. doi: 10.1186/s12888-024-06091-6.
PubMed 39333965
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisensory Therapy Alleviating MRI-Related Anxiety in Cancer Patients Via Brain-Autonomic Network Modulation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07692412
- Acronym / sponsor ID
- SKSY-2024-480-03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Guzheng music therapyOn 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. |
| AT Group (Lavender aromatherapy intervention) | Experimental | Behavioral: Lavender aromatherapyPatients 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. |
| Combined MT+AT Group (Music plus aromatherapy) | Experimental | Behavioral: Guzheng music therapy, Behavioral: Lavender aromatherapyPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guzheng music therapyPatients 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. | Behavioural | Combined MT+AT Group (Music plus aromatherapy), MT Group (Guzheng music intervention) |
| Lavender aromatherapyTwo 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. | Behavioural | AT Group (Lavender aromatherapy intervention), Combined MT+AT Group (Music plus aromatherapy) |
Primary outcome
Change in Hospital Anxiety and Depression Scale anxiety subscale score
Time frame: 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.
4 secondary outcomes
Change in low-frequency heart rate variability parameter
Time frame: Baseline (pre-MRI), during MRI scanning, and within 30 minutes immediately after completion of MRI examination
Change in high-frequency heart rate variability parameter
Time frame: 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
Time frame: Within 30 minutes after completion of clinical MRI scan and assigned study intervention
Standardized z-score degree centrality from resting-state functional MRI
Time frame: Within 30 minutes after completion of clinical MRI scan and assigned study intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 36335480Wen X, Shi J, Tan W, Jiang H, Wang D, Su J, Yang G, Zhang B. Effects of aromatherapy and music therapy on patients' anxiety during MRI examinations: a randomized controlled trial. Eur Radiol. 2023 Apr;33(4):2510-2518. doi: 10.1007/s00330-022-09230-3. Epub 2022 Nov 6.
- Background: PubMed 37998470Yoo O, Park SA. Anxiety-Reducing Effects of Lavender Essential Oil Inhalation: A Systematic Review. Healthcare (Basel). 2023 Nov 17;11(22):2978. doi: 10.3390/healthcare11222978.
- Background: PubMed 37325306Tan L, Liao FF, Long LZ, Ma XC, Peng YX, Lu JM, Qu H, Fu CG. Essential oils for treating anxiety: a systematic review of randomized controlled trials and network meta-analysis. Front Public Health. 2023 Jun 1;11:1144404. doi: 10.3389/fpubh.2023.1144404. eCollection 2023.
- Background: PubMed 40827258Sun C, Fei C, Lin R, Qiu X, Wang W, Jiang X, Sun F, Wang Y, Tang L. The Efficacy of Aromatherapy on Pain and Anxiety During Needle-Related Procedures in Adults: A Systematic Review and Meta-Analysis. J Pain Res. 2025 Aug 13;18:4053-4072. doi: 10.2147/JPR.S533076. eCollection 2025.
- Background: PubMed 40547443de Witte M, Aalbers S, Vink A, Friederichs S, Knapen A, Pelgrim T, Lampit A, Baker FA, van Hooren S. Music therapy for the treatment of anxiety: a systematic review with multilevel meta-analyses. EClinicalMedicine. 2025 Jun 9;84:103293. doi: 10.1016/j.eclinm.2025.103293. eCollection 2025 Jun.
- Background: PubMed 38862982Yang HF, Chang WW, Chou YH, Huang JY, Liao YS, Liao TE, Tseng HC, Chang ST, Chen HL, Ke YF, Tsai PF, Chan HM, Chang BJ, Hwang YT, Tsai HY, Lee YC. Impact of background music listening on anxiety in cancer patients undergoing initial radiation therapy: a randomized clinical trial. Radiat Oncol. 2024 Jun 11;19(1):73. doi: 10.1186/s13014-024-02460-3.
- Background: PubMed 37250411Xiao X, Chen W, Zhang X. The effect and mechanisms of music therapy on the autonomic nervous system and brain networks of patients of minimal conscious states: a randomized controlled trial. Front Neurosci. 2023 May 12;17:1182181. doi: 10.3389/fnins.2023.1182181. eCollection 2023.
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- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guzheng music therapy and Lavender aromatherapy in people with Malignant Tumor (Cancer) and MRI Examination-induced Anxiety, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hospital Anxiety and Depression Scale anxiety subscale score (time frame: Baseline (pre-MRI) and within 30 minutes immediately after completion of MRI examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07692412, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.