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

JRCT ID: jRCT1030240513

Registered date:28/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Cancer
• Date of first enrollment: 28/11/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Participants will be exposed to either sounds beyond the audible range only or a silent condition.

Outcome(s)

• Primary Outcome: 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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Miura Tomofumi