The Effects of Music on ANS and Anxiety in Healthy Elderly and Persons With SCD

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: Music; Behavioral: White noise

• Registration Number: NCT04177160
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Subjective cognition decline (SCD) is considered as a risk factor of dementia and associates not only with further cognition deterioration but with a higher anxiety level. Anxiety may lead to decreasing cognitive function and negative impacts on the well-being and quality of life. To avoid these consequences, reducing anxiety is an important step to treat SCD. To ease anxious emotions, music has been viewed as an effective, safe and easy alternative to medication. Thus, the purpose of this study is to investigate the effects of music on reducing the anxiety of the healthy elderly and SCD and further to compare the anxiety level between SCD and healthy controls.

Detailed Description

Single subject pretest-posttest design was used. 12 SCD subjects was recruited from the memory clinic and 12 healthy controls from the community. The anxiety level was assessed both by self-reports (State-Trait Anxiety Inventory and Visual Analogue Scale of Anxiety) and by objective measurements related to autonomic nervous system activities (heart rate variability and electrodermal activity). The participants underwent a memory task to induce anxiety. Next, preferred music and white noise were provided in random order. The anxiety level and the effects of music intervention between SCD and healthy controls will be further compared.

Study Timeline

• Study Start: 2019-04-15
• Primary Completion: 2019-11-13
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-26
• Study Completion: 2019-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• able to read and write Mandarin
• the scores of the Montreal Cognitive Assessment (MoCA) ≥ 24

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Exclusion Criteria

• cognitive status was affected by psychic problems, neurological disease or other conditions
• people with auditory and visual impairments
• people with obesity (BMI ≥ 27) or diabetes mellitus.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCD subjects	White noise	Patients were diagnosed with subjective cognition decline and referred by neurologists.
SCD subjects	Music	Patients were diagnosed with subjective cognition decline and referred by neurologists.
Healthy controls	Music	Voluntary healthy elderly recruited from the community.
Healthy controls	White noise	Voluntary healthy elderly recruited from the community.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale of Anxiety	After each stimulus task and intervention: on the 10th, 15th, 20th, 25th, 35th and 40th minute.	Participants reports their immediately subjective anxiety levels.
Heart rate variability	45 minutes	Heart activity was transformed into low- and high-frequency power components, which represented sympathetic and parasympathetic system activities respectively. It is recorded by skin conductance sensors wearing on the 2nd to 4th finger. These sensors connect to ProComp2™ Biofeedback System to collect biofeedback data. The data is further calibrated and analyzed by CardioPro Infiniti software.
Skin conductance	45 minutes	Electrodermal activity related to sympathetic system response (sweating). It is recorded by skin conductance sensors wearing on the 2nd to 4th finger. These sensors connect to ProComp2™ Biofeedback System to collect biofeedback data. The data is further calibrated and analyzed by CardioPro Infiniti software.

Secondary Outcome Measures

Name	Time	Method
Chinese version of state-trait anxiety inventory-trait version	Baseline	A self-report regards to participants' usual emotional status and personal characteristic based on a 4-point Likert scale and consists of 20 questions. People who get higher scores are considered having more anxious personality.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan