IBS - Irritable Bowel SyndromeNCT04817683
Study on the Relationship Between Mobile Phone Addiction and Functional Gastrointestinal Disorders
An observational study of IBS - Irritable Bowel Syndrome, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
A cross-sectional study was conducted to collect the relevant data of college students' mobile phone addiction and FGIDs (IBS, FD) in the form of questionnaire, so as to understand the situation of college students' mobile phone addiction and the incidence of FGIDs (IBS and FD), and explore the correlation, so as to… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 28 Dec 2020
- 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 17 years and older
- All sexes
- Child, Adult, Older adult
Study population: College students over the age of 17 across the country
Who may be able to join
- College students from all over the country, over 17 years old, have a physical examination before entering school
- Sign the informed consent form, voluntarily participate and fill in the questionnaire
Who cannot join
- People with diabetes, hyperthyroidism or hypothyroidism, peptic ulcer, inflammatory bowel disease, digestive tract tumor or severe medical and surgical disease
- History of abdominal surgery (such as esophagus, stomach, small intestine, colon, rectum, appendix, gallbladder, hysterectomy, cesarean section)
- Recently, there are some alarm symptoms, such as relieving black stool, bloody stool, hematemesis, abnormal anemia, fever, abnormal weight loss (no intention to lose weight, weight loss 5 kg in 3 months), change of defecation habits, dysphagia and so on
- In the past 4 weeks, he has taken drugs that affect the judgment of gastrointestinal symptoms, such as anti-inflammatory painkillers, diazepam drugs, anti-anxiety drugs, depressants and so on
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
About this study
Official title: Exploration of the Relationship Between Mobile Phone Addiction and Functional Gastrointestinal Disorders, a Cross-sectional Study
A cross-sectional study was conducted to collect the relevant data of college students' mobile phone addiction and FGIDs (IBS, FD) in the form of questionnaire, so as to understand the situation of college students' mobile phone addiction and the incidence of FGIDs (IBS and FD), and explore the correlation, so as to provide new ideas and scientific basis for the prevention, diagnosis and treatment of FGIDs among college students.
Read the detailed description
This study adopts the method of cross-sectional survey to collect the relevant data of Chinese college students' mobile phone addiction and FGIDs (IBS, FD) in the form of online and face-to-face questionnaire, so as to understand the situation of Chinese college students' mobile phone addiction and the incidence of FGIDs (IBS, FD), and explore the correlation, so as to provide new ideas and scientific basis for the prevention, diagnosis and treatment of FGIDs.
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- IBS，FD，MPA
- Medical subject headings
- Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of irritable bowel syndrome among College Students.Risk factors of irritable bowel syndrome.
The irritable bowel syndrome was diagnosed by the Rome IV diagnostic questionnaire, and then the incidence of irritable bowel syndrome was calculated by SPSS. Through PHQ-9 questionnaire to diagnose depression, GAD-7 questionnaire to diagnose anxiety, MPAI questionnaire to diagnose mobile phone addiction, AIS questionnaire to diagnose insomnia, logistic regression analysis to calculate OR value and P value, to understand the relationship between irritable bowel syndrome and anxiety, depression, insomnia, mobile phone addiction.
Measured: 2020.07.03-2020.12.28
Secondary outcomes (1)
Incidence of functional dyspepsia among College Students.Risk factors of functional dyspepsia.
The functional dyspepsia was diagnosed by the Rome IV diagnostic questionnaire, and then the incidence of functional dyspepsia was calculated by SPSS. Through PHQ-9 questionnaire to diagnose depression, GAD-7 questionnaire to diagnose anxiety, MPAI questionnaire to diagnose mobile phone addiction, AIS questionnaire to diagnose insomnia, logistic regression analysis to calculate OR value and P value, to understand the relationship between functional dyspepsia and anxiety, depression, insomnia, mobile phone addiction.
Measured: 2020.07.03-2020.12.28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Jul 2020
- Primary completion28 Dec 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinhai Wang, MD, Study director, Second Affilated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817683
- Sponsor's protocol ID
- 2020024
- Status last verified
- Mar 2021
- First submitted
- 3 Jul 2020
- Last updated
- 26 Mar 2021
- 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 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Relationship Between Mobile Phone Addiction and Functional Gastrointestinal Disorders, a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04817683
- Acronym / sponsor ID
- 2020024
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- IBS，FD，MPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 26 Mar 2021 (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.
A cross-sectional study was conducted to collect the relevant data of college students' mobile phone addiction and FGIDs (IBS, FD) in the form of questionnaire, so as to understand the situation of college students' mobile phone addiction and the incidence of FGIDs (IBS and FD), and explore the correlation, so as to provide new ideas and scientific basis for the prevention, diagnosis and treatment of FGIDs among college students.
Detailed description
This study adopts the method of cross-sectional survey to collect the relevant data of Chinese college students' mobile phone addiction and FGIDs (IBS, FD) in the form of online and face-to-face questionnaire, so as to understand the situation of Chinese college students' mobile phone addiction and the incidence of FGIDs (IBS, FD), and explore the correlation, so as to provide new ideas and scientific basis for the prevention, diagnosis and treatment of FGIDs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- College students over the age of 17 across the country
Key inclusion criteria (2 listed)
- College students from all over the country, over 17 years old, have a physical examination before entering school
- Sign the informed consent form, voluntarily participate and fill in the questionnaire
Key exclusion criteria (4 listed)
- People with diabetes, hyperthyroidism or hypothyroidism, peptic ulcer, inflammatory bowel disease, digestive tract tumor or severe medical and surgical disease
- History of abdominal surgery (such as esophagus, stomach, small intestine, colon, rectum, appendix, gallbladder, hysterectomy, cesarean section)
- Recently, there are some alarm symptoms, such as relieving black stool, bloody stool, hematemesis, abnormal anemia, fever, abnormal weight loss (no intention to lose weight, weight loss 5 kg in 3 months), change of defecation habits, dysphagia and so on
- In the past 4 weeks, he has taken drugs that affect the judgment of gastrointestinal symptoms, such as anti-inflammatory painkillers, diazepam drugs, anti-anxiety drugs, depressants and so on
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of irritable bowel syndrome among College Students.Risk factors of irritable bowel syndrome.
Time frame: 2020.07.03-2020.12.28
The irritable bowel syndrome was diagnosed by the Rome IV diagnostic questionnaire, and then the incidence of irritable bowel syndrome was calculated by SPSS. Through PHQ-9 questionnaire to diagnose depression, GAD-7 questionnaire to diagnose anxiety, MPAI questionnaire to diagnose mobile phone addiction, AIS questionnaire to diagnose insomnia, logistic regression analysis to calculate OR value and P value, to understand the relationship between irritable bowel syndrome and anxiety, depression, insomnia, mobile phone addiction.
1 secondary outcome
Incidence of functional dyspepsia among College Students.Risk factors of functional dyspepsia.
Time frame: 2020.07.03-2020.12.28
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 26 Mar 2021.
- 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.
Jinhai Wang, MD study director
Second Affilated Hospital of Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBS - Irritable Bowel Syndrome, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
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 26 Mar 2021. 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 China. 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?
Incidence of irritable bowel syndrome among College Students.Risk factors of irritable bowel syndrome. (time frame: 2020.07.03-2020.12.28). 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 26 Mar 2021.