Smartphone Users, Smartphone Addiction, Anxiety, and Skin ConductanceNCT04133597
The Relationship Among Electroencephalography,Skin Conductance Response,Heart Rate Variability and Mental Health Among Smartphone Users After Receiving Texting or Calling
A study testing social media stimuli (Line app) in people with Smartphone Users, Smartphone Addiction, Anxiety, and Skin Conductance, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smartphone Users, Smartphone Addiction, Anxiety, and Skin Conductance
- What is being tested?
- social media stimuli (Line app)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Mar 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- were older than 20 years of age and (b) used a smartphone with internet and Line app.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- social media stimuli (Line app)
- Keywords
- skin conductance, anxiety, smartphone users, smartphone addiction
- Medical subject headings
- Internet Addiction Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social media stimuli (Line app)Device
social media stimuli (Line app) with texting messages or calls
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | 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. Receives: Device: social media stimuli (Line app) |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin conductance
change of skin conductance (micro-Siemens (μS))
Measured: 3 minutes
Heart Rate Variability (HRV)
Heart Rate Variability is a measure which indicates the variation in your heartbeats within a specific timeframe.
Measured: 3 minutes
Electroencephalography (Hz)
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
Measured: 5 minutes
Secondary outcomes (2)
The Zung Self-Rating Anxiety Scale
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.
Measured: 10 minutes
The Chinese version of Smartphone Addiction Inventory (SPAI)
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start14 Mar 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smartphone Users, Smartphone Addiction, Anxiety, and Skin ConductanceStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133597
- Sponsor's protocol ID
- KMUHIRB-E(I)-20170016
- Status last verified
- Sep 2019
- First submitted
- 11 Sep 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Among Electroencephalography,Skin Conductance Response,Heart Rate Variability and Mental Health Among Smartphone Users After Receiving Texting or Calling
- ClinicalTrials.gov ID
- NCT04133597
- Acronym / sponsor ID
- KMUHIRB-E(I)-20170016
- Keywords
- skin conductance, anxiety, smartphone users, smartphone addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: social media stimuli (Line app)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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- were older than 20 years of age and (b) used a smartphone with internet and Line app.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| social media stimuli (Line app)social media stimuli (Line app) with texting messages or calls | Device | Interventional |
Primary outcome
skin conductance
Time frame: 3 minutes
change of skin conductance (micro-Siemens (μS))
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.
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
2 secondary outcomes
The Zung Self-Rating Anxiety Scale
Time frame: 10 minutes
The Chinese version of Smartphone Addiction Inventory (SPAI)
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing social media stimuli (Line app) in people with Smartphone Users, Smartphone Addiction, Anxiety, and Skin Conductance, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin conductance (time frame: 3 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.