- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06725394
Effect of Smartphone Addiction on Pregnancy
December 4, 2024 updated by: Sena Dilek Aksoy, Kocaeli University
Effect of Smartphone Addiction on Neck Disability During Pregnancy: the Mediating Role of Stress
This study will investigate the effect of smartphone addiction on neck disability during pregnancy and its mediating role on stress.
The study will be conducted between September 2023 and April 2024.
Data will be collected using the information form, Smartphone Addiction Scale-Short Version (SAS-SV), Perceived Stress Scale (PSS-10) and Neck Disability Index (NDI).
Multiple regression and structural equation modeling will be used in the analysis of the data.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Objective: After reviewing the relevant studies, we thought that smartphone addiction may negatively affect neck injury and perceived stress may play a mediating role in this relationship. In this context, our research questions are as follows:
- Do smartphone addiction and certain characteristics significantly predict stress in pregnant women?
- Do smartphone addiction and certain characteristics significantly predict neck injury in pregnant women?
- Does stress have a mediating effect on the relationship between smartphone addiction and neck injury in pregnant women? The research is a cross-sectional, analytical and screening study. The research will be conducted face-to-face with pregnant participants who apply to the pregnancy follow-up clinic of a public hospital and meet the research criteria and voluntarily participate in the research. Verbal and written consent will be obtained from all participants before data collection. The principles of the Declaration of Helsinki will be followed throughout the study. Data of the study will be collected using the Information Form, Smartphone Addiction Scale-Short Version (SAS-SV), Perceived Stress Scale-10 (PSS-10) and Neck Disability Index (NDI). Statistical analyses will be given as mean, standard deviation, median, minimum and maximum. T-tests will be used to compare categorical variables with scale scores, Pearson correlation to examine the relationship between scales and ANOVA to compare scale scores with three or more groups of categorical variables. Linear regression analysis will be used to examine the effects of SAS-SV scores and sociodemographic characteristics on PSS-10 and NDI. In addition, the mediating effect of PSS-10 on SAS-SV and NDI will be examined using a linear regression model. Analysis results will be considered significant at p < 0.05.
Study Type
Observational
Enrollment (Actual)
428
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
-
-
-
Kocaeli, Turkey, 41380
- Kocaeli University
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Pregnant women between the ages of 18-49
Description
Inclusion Criteria:
- Individuals aged between 18 and 49 years,
- With a gestational age of 20 weeks or more,
- No pregnancy complications,
Exclusion Criteria:
- Those with musculoskeletal system diseases (such as rheumatoid arthritis, ankylosing spondylitis, Scheuermann's disease, Ehlers-Danlos syndrome, spinal surgeries, nerve root compression, spondylolisthesis comorbidities)
- Those with diagnosed mental disorders
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Pregnant women
|
Data were collected using an information form, the Smartphone Addiction Scale-Short Version (SAS-SV), the Perceived Stress Scale (PSS-10), and the Neck Disability Index (NDI).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Filling out the survey
Time Frame: 30 minutes
|
Filling out the tools used in the research
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sena Dilek Aksoy, Ph.D., Kocaeli University
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)
September 1, 2023
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
April 30, 2024
Study Registration Dates
First Submitted
November 26, 2024
First Submitted That Met QC Criteria
December 4, 2024
First Posted (Estimated)
December 10, 2024
Study Record Updates
Last Update Posted (Estimated)
December 10, 2024
Last Update Submitted That Met QC Criteria
December 4, 2024
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sdilek10
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
product manufactured in and exported from the U.S.
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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