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Completed

NCT Number: NCT04177160

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

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.

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Key information

Conditions

Dementia Anxiety Disorders Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Music

Behavioral

Subjects sit still and listen to preferred music for 5 minutes.

White Noise

Behavioral

Subjects sit still and listen to white noise for 5 minutes.

Primary outcomes

  1. Heart rate variability

    Time frame: 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.

  2. Skin conductance

    Time frame: 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.

  3. Visual Analogue Scale of Anxiety

    Time frame: After each stimulus task and intervention: on the 10th, 15th, 20th, 25th, 35th and 40th minute.

    Participants reports their immediately subjective anxiety levels.

Secondary outcomes

  1. Chinese version of state-trait anxiety inventory-trait version

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Effects of Music on Autonomic Nervous System and Anxiety in Healthy Elderly and Persons With Subjective Cognitive Decline

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 26, 2019
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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