- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04133597
The Relationship Among Electroencephalography,Skin Conductance Response,Heart Rate Variability and Mental Health Among Smartphone Users After Receiving Texting or Calling
October 18, 2019 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
The number of smartphone users in Taiwan continues to increase exponentially.
Smartphone addiction tends to not only disrupt the ability of social communication but cause physical and psychological problems as well.
This study examined the relationship among skin conductance, electroencephalography, heart rate variability (HRV), social interaction anxiety and smartphone addiction among Line apps users, and we also tried to identify associated factors for further interventions.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kaohsiung, Taiwan, 80708
- Kaohsiung Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
(a) were older than 20 years of age and (b) used a smartphone with internet and Line app.
Exclusion Criteria:
the participants were those who (a) had alcoholism or drug dependence; (b) had any pre-existing major mental disorders; (c) had history of brain injury; and (d) had palmar hyperhidrosis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional
Two experimental steps: baseline skin conductance measurements (step 1, three minutes) and measurements of SC after social media stimulation with Line messages or calls (step 2, three minutes).
With a 5-minute rest period after these two steps completed, then each participant fill out questionnaires for assessing anxiety and problematic smartphone use.
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social media stimuli (Line app) with texting messages or calls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
skin conductance
Time Frame: 3 minutes
|
change of skin conductance (micro-Siemens (μS))
|
3 minutes
|
Heart Rate Variability (HRV)
Time Frame: 3 minutes
|
Heart Rate Variability is a measure which indicates the variation in your heartbeats within a specific timeframe.
|
3 minutes
|
Electroencephalography (Hz)
Time Frame: 5 minutes
|
Electroencephalography (EEG) is an electrophysiological monitoring method to record .... EEG is commonly recorded at sampling rates between 250 and 2000 Hz in clinical and research settings
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Zung Self-Rating Anxiety Scale
Time Frame: 10 minutes
|
The Zung Self-Rating Anxiety Scale (SAS) was developed by Zung (1971) for measuring levels of anxiety.
It has been conducted in a number of cross-cultural studies, and translated into different languages with nearly 20 versions.
The SAS test is a self-administered questionnaire with 20 items.
The total scores of the SAS range from 20 to 80, with higher scores indicating a higher level of anxiety.
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10 minutes
|
The Chinese version of Smartphone Addiction Inventory (SPAI)
Time Frame: 10 minutes
|
The Chinese version of Smartphone Addiction Inventory (SPAI) was used to examine participant's PSU, and it was designed and developed on the basis of the Chen Internet Addiction Scale (CIAS) with a four-factor structure: compulsive behavior, functional impairment, withdrawal and tolerance [24].
The total scores of SPAI range from 26 to 104, and the higher scores indicate higher levels of smartphone addition.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2017
Primary Completion (Actual)
January 31, 2019
Study Completion (Actual)
January 31, 2019
Study Registration Dates
First Submitted
September 11, 2019
First Submitted That Met QC Criteria
October 18, 2019
First Posted (Actual)
October 21, 2019
Study Record Updates
Last Update Posted (Actual)
October 21, 2019
Last Update Submitted That Met QC Criteria
October 18, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-E(I)-20170016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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