Smartphone AddictionNCT06400576
Smartphone & Headphone Effects on Baropodometric Parameters
An observational study of Smartphone Addiction and Postural; Defect, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this observational study is to observe baropodometric parameters such as postural sway and foot pressure distrubiton in healthy young participants between the ages of 18-35. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Smartphone Addiction, Postural; Defect, Dual Task
- What is being tested?
- Headphone and Smartphone Intervention
- How many people
- 35 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Apr 2024to 23 Oct 2024
- Phase
- Observational
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy young people who are volunteering to participate the study.
Who may be able to join
- Agreeing to participate in the study voluntarily,
- Being between the ages of 18-35
Who cannot join
- Not agreeing to participate in the study voluntarily.
- Having a congenital spinal cord anomaly
- Existing neurological, orthopedic, inflammatory, cardiovascular, rheumatological, vestibular problems
- Having a surgical history of the spinal region
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hatice Cetin
Ankara, 06800
Hacettepe University
Ankara
About this study
Official title: Effects of Smartphone and Headphone Usage on Baropodometric Parameters in Healthy Individuals
The goal of this observational study is to observe baropodometric parameters such as postural sway and foot pressure distrubiton in healthy young participants between the ages of 18-35. The main questions it aims to answer are:
- How does headphone usage affect baropodometric parameters in healthy young individuals?
- How does texting affect baropodometric parameters in healthy young individuals?
- How does headphone usage while texting affect baropodometric parameters in healthy young individuals?
Read more
Participants will:
- Only be evaluated once.
- Stand on the Baropodometric device platform while standing, texting, listening to music, texting while listening to music for the static and posturographic balance evaluation.
- Walk on the baropdometric device platform while standing, texting, listening to music, texting while listening to music for dynamic evaluation.
Read the detailed description
During our daily lives, the individuals perform many functions simultaneously. Two devices that modern technology has brought us are headphones and mobile phones, both of which are commonly used. Studies have shown that posture oscillation changes during walking while using a phone, but same studies also stated that more comprehensive studies are needed. There is no study in the literature that examines postural oscillation and foot pressure distribution while listening to music with headphones and messaging. The aim of this observational study is to evaluate the postural oscillation and foot pressure distribution during headphone use and messaging in healthy participants aged 18-35. The sample size of 35 participants was determined based on a similar study example using G-Power analysis. Participants will be assesed at Hacettepe University, Faculty of Physical Therapy and Rehabilitation. Participants will be selected based on eligibility criteria, and there will be only one group in the study; therefore, randomization will not be performed. Participants enrolled in the study will be evaluated using the FreeMED force platform (Sensor Medica, Italy). The platform itself is 40x40 cm in size and comes with two plates, each one meter long. When all components are assembled, a continuous surface of 2.4 meters is obtained. Participants will participate in static, posturographic, and dynamic evaluations. In each evaluation, participants will first stand still, then put on headphones and listen to music at 80 decibels with a tempo of 130 bpm, then type a message, and finally type a message while listening to music. Static evaluation will provide information about foot pressure distribution; posturographic evaluation will include Romberg tests with eyes open, eyes closed, standing on one foot, and standing on two feet; and dynamic evaluation will assess participants' walking phases and speed. The statistical analysis of the study will be performed using SPSS 23.0 software.
- Conditions
- Smartphone Addiction, Postural; Defect, Dual Task
- Being tested
- Headphone and Smartphone Intervention
- Keywords
- Postural oscillation, Headphone use, Messaging, Balance, Gait, Foot Pressure Distrubition, Smartphone addiction, Daily activites
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headphone and Smartphone InterventionOther
Also called FreeMed Baropodometric Device
Asessment of participants' static balance and pressure distrubiton, posturographic balance and dynamic balance whilst using headphones and messaging.
| Study group | Role | What they receive |
|---|---|---|
| Headphone and Smartphone Usage Group | The group where participants listen to music while messaging and also where these activities are evaluated separately. The only group in the study. Receives: Other: Headphone and Smartphone Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baropodometer assessments- Static pressure distribution
Pressure distribution will be assessed with FreeMed baropodometric platform and the recording measurement unit will be percentages.
Measured: through study intervention, an average of 15 minutes
Baropodometer assessments- Posturographic center of gravity
Center of gravity will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
Measured: through study intervention, an average of 15 minutes
Baropodometer assessments- Posturographic oscillations
Oscillations will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
Measured: through study intervention, an average of 15 minutes
Baropodometer assesments - Posturographic Sway Length
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
Measured: through study intervention, an average of 15 minutes
Baropodometer assesments - Posturographic Displacement Towards X and Y axis
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
Measured: through study intervention, an average of 15 minutes
Baropodometer assessments- Posturographic average sway velocity
Sway velocity will be assessed with FreeMed baropodometric platform and the recording measurement unit will be degrees.
Measured: through study intervention, an average of 15 minutes
Baropodometer assessments- Dynamic average surface
Average surface will be assessed with FreeMed baropodometric platform and the recording measurement unit will be cm.
Measured: through study intervention, an average of 15 minutes
Baropodometer assessments- Dynamic average speed
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters/second.
Measured: through study intervention, an average of 15 minutes
Baropodometer assesments - Dynamic Gait Phase Durations
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be percentages
Measured: through study intervention, an average of 15 minutes
Feet Loading Pattern - Dynamic Longitudinal Arc
It will be assessed with FreeMed baropodometric platform and will be used to asses the feet loading pattern.
Measured: through study intervention, an average of 15 minutes
Feet Loading Pattern - Forefoot Reatfoot Load
It will be assessed with FreeMed baropodometric platform and will be used to asses the feet loading pattern.
Measured: through study intervention, an average of 15 minutes
Feet Loading Pattern - Medial Lateral Load
It will be assessed with FreeMed baropodometric platform and will be used to asses the feet loading pattern.
Measured: through study intervention, an average of 15 minutes
Secondary outcomes (4)
Forward Head Posture
It will be assessed with a digital inclinometer, the measurement unit will be in degrees.
Measured: At Baseline
New York Posture Assesment
This form will assess participants' postural alignment. Total scores range from 13 to 65, with results categorized as: 'excellent' (above 45), 'good' (40-44), 'fair' (30-39), 'poor' (20-29), and 'very poor'.
Measured: At Baseline
International Physical Activity Questionnaire
This form will assess participants' physical fitness and well-being. Based on MET minutes per week, the results are categorized into three activity levels: inactive, minimally active and very active.
Measured: At Baseline
The Cognitive Flexibility Inventory
The Cognitive Flexibility Inventory is a 20-item self-report measure to monitor how often individuals engaged in cognitive behavioural thought challenging interventions. The total score ranges between 20 and 140, where higher scores indicate more cognitive flexibility.
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start25 Apr 2024
- Primary completion28 Jul 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smartphone AddictionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE ÇETİN, Hacettepe University
- Investigators
- Hatice Cetin, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400576
- Sponsor's protocol ID
- SPP
- Status last verified
- Oct 2024
- First submitted
- 29 Apr 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Smartphone and Headphone Usage on Baropodometric Parameters in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06400576
- Acronym / sponsor ID
- SPP
- Conditions
- Smartphone Addiction, Postural; Defect, Dual Task
- Keywords
- Postural oscillation, Headphone use, Messaging, Balance, Gait, Foot Pressure Distrubition, Smartphone addiction, Daily activites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 6 May 2024 (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 goal of this observational study is to observe baropodometric parameters such as postural sway and foot pressure distrubiton in healthy young participants between the ages of 18-35. The main questions it aims to answer are:
- How does headphone usage affect baropodometric parameters in healthy young individuals?
- How does texting affect baropodometric parameters in healthy young individuals?
- How does headphone usage while texting affect baropodometric parameters in healthy young individuals?
Participants will:
- Only be evaluated once.
- Stand on the Baropodometric device platform while standing, texting, listening to music, texting while listening to music for the static and posturographic balance evaluation.
- Walk on the baropdometric device platform while standing, texting, listening to music, texting while listening to music for dynamic evaluation.
Detailed description
During our daily lives, the individuals perform many functions simultaneously. Two devices that modern technology has brought us are headphones and mobile phones, both of which are commonly used. Studies have shown that posture oscillation changes during walking while using a phone, but same studies also stated that more comprehensive studies are needed. There is no study in the literature that examines postural oscillation and foot pressure distribution while listening to music with headphones and messaging. The aim of this observational study is to evaluate the postural oscillation and foot pressure distribution during headphone use and messaging in healthy participants aged 18-35. The sample size of 35 participants was determined based on a similar study example using G-Power analysis. Participants will be assesed at Hacettepe University, Faculty of Physical Therapy and Rehabilitation. Participants will be selected based on eligibility criteria, and there will be only one group in the study; therefore, randomization will not be performed. Participants enrolled in the study will be evaluated using the FreeMED force platform (Sensor Medica, Italy). The platform itself is 40x40 cm in size and comes with two plates, each one meter long. When all components are assembled, a continuous surface of 2.4 meters is obtained. Participants will participate in static, posturographic, and dynamic evaluations. In each evaluation, participants will first stand still, then put on headphones and listen to music at 80 decibels with a tempo of 130 bpm, then type a message, and finally type a message while listening to music. Static evaluation will provide information about foot pressure distribution; posturographic evaluation will include Romberg tests with eyes open, eyes closed, standing on one foot, and standing on two feet; and dynamic evaluation will assess participants' walking phases and speed. The statistical analysis of the study will be performed using SPSS 23.0 software.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Headphone and Smartphone Usage Group | – | Other: Headphone and Smartphone InterventionThe group where participants listen to music while messaging and also where these activities are evaluated separately. The only group in the study. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young people who are volunteering to participate the study.
Key inclusion criteria (2 listed)
- Agreeing to participate in the study voluntarily,
- Being between the ages of 18-35
Key exclusion criteria (4 listed)
- Not agreeing to participate in the study voluntarily.
- Having a congenital spinal cord anomaly
- Existing neurological, orthopedic, inflammatory, cardiovascular, rheumatological, vestibular problems
- Having a surgical history of the spinal region
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 |
|---|---|---|
| Headphone and Smartphone InterventionAlso: FreeMed Baropodometric DeviceAsessment of participants' static balance and pressure distrubiton, posturographic balance and dynamic balance whilst using headphones and messaging. | Other | Headphone and Smartphone Usage Group |
Primary outcome
Baropodometer assessments- Static pressure distribution
Time frame: through study intervention, an average of 15 minutes
Pressure distribution will be assessed with FreeMed baropodometric platform and the recording measurement unit will be percentages.
Baropodometer assessments- Posturographic center of gravity
Time frame: through study intervention, an average of 15 minutes
Center of gravity will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
Baropodometer assessments- Posturographic oscillations
Time frame: through study intervention, an average of 15 minutes
Oscillations will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
Baropodometer assesments - Posturographic Sway Length
Time frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
Baropodometer assesments - Posturographic Displacement Towards X and Y axis
Time frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters.
Baropodometer assessments- Posturographic average sway velocity
Time frame: through study intervention, an average of 15 minutes
Sway velocity will be assessed with FreeMed baropodometric platform and the recording measurement unit will be degrees.
Baropodometer assessments- Dynamic average surface
Time frame: through study intervention, an average of 15 minutes
Average surface will be assessed with FreeMed baropodometric platform and the recording measurement unit will be cm.
Baropodometer assessments- Dynamic average speed
Time frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be milimeters/second.
Baropodometer assesments - Dynamic Gait Phase Durations
Time frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and the recording measurement unit will be percentages
Feet Loading Pattern - Dynamic Longitudinal Arc
Time frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and will be used to asses the feet loading pattern.
Feet Loading Pattern - Forefoot Reatfoot Load
Time frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and will be used to asses the feet loading pattern.
Feet Loading Pattern - Medial Lateral Load
Time frame: through study intervention, an average of 15 minutes
It will be assessed with FreeMed baropodometric platform and will be used to asses the feet loading pattern.
4 secondary outcomes
Forward Head Posture
Time frame: At Baseline
New York Posture Assesment
Time frame: At Baseline
International Physical Activity Questionnaire
Time frame: At Baseline
The Cognitive Flexibility Inventory
Time frame: At Baseline
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 24 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Hatice Cetin principal investigator
Hacettepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smartphone Addiction and Postural; Defect, run by Hacettepe University at 2 sites in Turkey (Türkiye).
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 2 inclusion and 4 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Baropodometer assessments- Static pressure distribution (time frame: through study intervention, an average of 15 minutes). The study lists 12 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 24 Oct 2024.