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Exploratory Randomized Controlled Study on the Impact of High-Resolution Natural Sounds Beyond the Audible Range on Biometrics and Healing in Patients with Advanced Cancer

Exploratory Randomized Controlled Study on the Impact of High-Resolution Natural Sounds Beyond the Audible Range on Biometrics and Healing in Patients with Advanced Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030240513
Enrollment
30
Registered
2024-11-28
Start date
2024-11-28
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Cancer cancer,

Interventions

Participants will be exposed to either sounds beyond the audible range only or a silent condition.
music therapy
extraaudible range, music therapy

Sponsors

Miura Tomofumi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Eligible participants must meet the following criteria: Age: 18 years or older at the time of obtaining consent. Cancer Diagnosis: Diagnosed with cancer either histologically or clinically. Hospitalization: Currently admitted to a palliative care ward. Monitoring Capability: Able to undergo EEG and ECG monitoring. Language: Native Japanese speaker. Delirium Status: Not diagnosed with delirium (negative Confusion Assessment Method, CAM). Consent: Capable of understanding and signing the informed consent document.

Exclusion criteria

Exclusion criteria: Exclusion criteria apply if any of the following conditions are met: CNS Disorders: History of central nervous system conditions, such as cerebral infarction, cerebral hemorrhage, or metastatic brain tumors. Severe Symptoms: Presence of severe physical or psychological symptoms. Hearing Loss: Hearing impairment requiring the use of a hearing aid in daily life. Oral/Mandibular Restrictions: Limited tongue or jaw mobility due to lesions or treatments. Researcher Judgment: Deemed unsuitable for participation by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Comparison of the change in the proportion of alpha waves in EEG when exposed to sounds beyond the audible range versus a silent condition

Secondary

MeasureTime frame
Comparison of changes in EEG power spectrum and amplitude when exposed to sounds beyond the audible range versus a silent condition. Comparison of changes in EEG power spectrum and amplitude when exposed to natural sounds containing frequencies beyond the audible range versus natural sounds with those frequencies removed. Comparison of changes in autonomic nervous function and heart rate variability analysis based on ECG when: Exposed to sounds beyond the audible range versus a silent condition, and Exposed to natural sounds containing frequencies beyond the audible range versus natural sounds with those frequencies removed. Comparison of changes in the healing scale (total score and subscales) when: Exposed to sounds beyond the audible range versus a silent condition, and Exposed to natural sounds containing frequencies beyond the audible range versus natural sounds with those frequencies removed. Comparison of changes in symptom scales (ESAS-r-J) when: Exposed to sounds beyond the audible range versus a silent condition, and Exposed to natural sounds containing frequencies beyond the audible range versus natural sounds with those frequencies removed. Comparison of PGI-C (Patient Global Impression of Change) when: Exposed to sounds beyond the audible range versus a silent condition, and Exposed to natural sounds containing frequencies beyond the audible range versus natural sounds with those frequencies removed.

Contacts

Public ContactKoshin Katsu

National Cancer Center Hospital East

kokats@east.ncc.go.jp+81-471331111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026