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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04177160

Collaborator

(none)

Enrollment

Location

Arms

8.5

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Behavioral: Music Behavioral: White noise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 15, 2019

Actual Primary Completion Date :

Nov 13, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SCD subjects Patients were diagnosed with subjective cognition decline and referred by neurologists.	Behavioral: Music Subjects sit still and listen to preferred music for 5 minutes. Behavioral: White noise Subjects sit still and listen to white noise for 5 minutes.
Experimental: Healthy controls Voluntary healthy elderly recruited from the community.	Behavioral: Music Subjects sit still and listen to preferred music for 5 minutes. Behavioral: White noise Subjects sit still and listen to white noise for 5 minutes.

Arm

Intervention/Treatment

Experimental: SCD subjects

Patients were diagnosed with subjective cognition decline and referred by neurologists.

Behavioral: Music

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

Behavioral: White noise

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

Experimental: Healthy controls

Voluntary healthy elderly recruited from the community.

Behavioral: Music

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

Behavioral: White noise

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

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.