Regional AnesthesiaNCT05416541
Uncontrolled Disinformation About Regional Anesthesia and Pregnant Patients.
An observational study of Regional Anesthesia and Anxiety, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
Trial summary
Nowadays, hundreds of information about regional anesthesia are accessed from any internet search engine when a question is written about the methods of anesthesia that can be applied during C/S. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia, Anxiety, Social Media Addiction
- What is being tested?
- social media
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Nov 2023
- How long will I take part?
- 2 Months
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: caesarian section ASA I-II, who speaks and writes Turkish patients
Who may be able to join
- ASA I-II, who speaks and writes Turkish
Who cannot join
- psychiatric illness
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aygün Güler
Ankara, Type A Choice Below ..., 06810
Ankara City Hospital
Ankara, 06800
About this study
Official title: Uncontrolled Disinformation About Regional Anesthesia From Social Media, and the Effect on the Pregnant Patients Decisions.
Nowadays, hundreds of information about regional anesthesia are accessed from any internet search engine when a question is written about the methods of anesthesia that can be applied during C/S. This information may have positive or negative effects on the patient, as well as include uncontrolled, unsupervised comments, articles and images. Our aim is primarily to evaluate whether our patients are exchanging information via social media or the internet and the effects of these shares on their concerns.
Read the detailed description
Social media has become a place to receive and share information today, especially for women of childbearing age. according to a study published in 2019, 78% of social media users are women and 80% of them are in the 18-40 age range. Again, studies have shown that women often use a large number of alternative platforms to receive or share information about pregnancy and parenting.
It has been shown that there are 3 different reasons why patients follow medical content on social media. Behaviorally, patients can be self-healing with the information they receive; cognitively, the search for information about their own condition and the desire to understand their condition is the desire to be able to share common feelings with other people who are in the same situation emotionally.
Anxiety develops in the preoperative period in 21-25% of cesarean section patients. This anxiety response can cause premature and low birth weight baby birth by vasoconstricting the uterine artery through the autonomic central nervous system.
It is common for pregnant women who already have concerns before the cesarean section that will take place to look for information about both the surgery and the anesthesia method that will be applied. Studies including patients who were watched preoperative anesthesia videos about the anesthesia technique, has showed low anxiety levels. However, this videos were custom made videos by the organizations such as hospitals, universities.
Nowadays, hundreds of information about regional anesthesia are accessed from any internet search engine when a question is written about the methods of anesthesia that can be applied during C/S. This information may have positive or negative effects on the patient, as well as include uncontrolled, unsupervised comments, articles and images. Our aim is primarily to evaluate whether our patients are exchanging information via social media or the internet and the effects of these shares on their concerns
- Being tested
- social media
- Keywords
- social media, anxiety, regional anesthesia
- Medical subject headings
- Anxiety Disorders, Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social mediaBehavioural
ASA I-II, who speaks and writes Turkish and do not have psychiatric illness patients will attend the study.
| Study group | Role | What they receive |
|---|---|---|
| pregnant patients | Not described Receives: Behavioral: social media |
What is being measured
The primary outcome is the main question the study is designed to answer.
social media effect on the anesthesia choice
the effect of the uncontrolled disinformation on the patients decision of the anesthesia
Measured: were performed before the operation when the patient hospitalized.
social media and patient anxiety about anesthesia and surgery
anxiety will be measured
Measured: before the operation when the patient hospitalized.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 May 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- namık nebi ozcan, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416541
- Sponsor's protocol ID
- E1-21-1739
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asiodu IV, Waters CM, Dailey DE, Lee KA, Lyndon A. Breastfeeding and use of social media among first-time African American mothers. J Obstet Gynecol Neonatal Nurs. 2015 Mar-Apr;44(2):268-78. doi: 10.1111/1552-6909.12552. Epub 2015 Feb 24.
PubMed 25712127Gleeson DM, Craswell A, Jones CM. Women's use of social networking sites related to childbearing: An integrative review. Women Birth. 2019 Aug;32(4):294-302. doi: 10.1016/j.wombi.2018.10.010. Epub 2018 Dec 31.
PubMed 30606628Holtz B, Smock A, Reyes-Gastelum D. Connected Motherhood: Social Support for Moms and Moms-to-Be on Facebook. Telemed J E Health. 2015 May;21(5):415-21. doi: 10.1089/tmj.2014.0118. Epub 2015 Feb 9.
PubMed 25665177Pretorius K, Johnson KE, Rew L. An Integrative Review: Understanding Parental Use of Social Media to Influence Infant and Child Health. Matern Child Health J. 2019 Oct;23(10):1360-1370. doi: 10.1007/s10995-019-02781-w.
PubMed 31222601Barello S, Triberti S, Graffigna G, Libreri C, Serino S, Hibbard J, Riva G. eHealth for Patient Engagement: A Systematic Review. Front Psychol. 2016 Jan 8;6:2013. doi: 10.3389/fpsyg.2015.02013. eCollection 2015.
PubMed 26779108Field T. Prenatal anxiety effects: A review. Infant Behav Dev. 2017 Nov;49:120-128. doi: 10.1016/j.infbeh.2017.08.008. Epub 2017 Sep 5.
PubMed 28886563Perkin MR, Bland JM, Peacock JL, Anderson HR. The effect of anxiety and depression during pregnancy on obstetric complications. Br J Obstet Gynaecol. 1993 Jul;100(7):629-34. doi: 10.1111/j.1471-0528.1993.tb14228.x.
PubMed 8369244Che YJ, Gao YL, Jing J, Kuang Y, Zhang M. Effects of an Informational Video About Anesthesia on Pre- and Post-Elective Cesarean Section Anxiety and Recovery: A Randomized Controlled Trial. Med Sci Monit. 2020 Apr 8;26:e920428. doi: 10.12659/MSM.920428.
PubMed 32265432
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled Disinformation About Regional Anesthesia From Social Media, and the Effect on the Pregnant Patients Decisions.
- ClinicalTrials.gov ID
- NCT05416541
- Acronym / sponsor ID
- E1-21-1739
- Keywords
- social media, anxiety, regional anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 13 Jun 2022 (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.
Nowadays, hundreds of information about regional anesthesia are accessed from any internet search engine when a question is written about the methods of anesthesia that can be applied during C/S. This information may have positive or negative effects on the patient, as well as include uncontrolled, unsupervised comments, articles and images. Our aim is primarily to evaluate whether our patients are exchanging information via social media or the internet and the effects of these shares on their concerns.
Detailed description
Social media has become a place to receive and share information today, especially for women of childbearing age. according to a study published in 2019, 78% of social media users are women and 80% of them are in the 18-40 age range. Again, studies have shown that women often use a large number of alternative platforms to receive or share information about pregnancy and parenting.
It has been shown that there are 3 different reasons why patients follow medical content on social media. Behaviorally, patients can be self-healing with the information they receive; cognitively, the search for information about their own condition and the desire to understand their condition is the desire to be able to share common feelings with other people who are in the same situation emotionally.
Anxiety develops in the preoperative period in 21-25% of cesarean section patients. This anxiety response can cause premature and low birth weight baby birth by vasoconstricting the uterine artery through the autonomic central nervous system.
It is common for pregnant women who already have concerns before the cesarean section that will take place to look for information about both the surgery and the anesthesia method that will be applied. Studies including patients who were watched preoperative anesthesia videos about the anesthesia technique, has showed low anxiety levels. However, this videos were custom made videos by the organizations such as hospitals, universities.
Nowadays, hundreds of information about regional anesthesia are accessed from any internet search engine when a question is written about the methods of anesthesia that can be applied during C/S. This information may have positive or negative effects on the patient, as well as include uncontrolled, unsupervised comments, articles and images. Our aim is primarily to evaluate whether our patients are exchanging information via social media or the internet and the effects of these shares on their concerns
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant patients | – | Behavioral: social media |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- caesarian section ASA I-II, who speaks and writes Turkish patients
Key inclusion criteria (1 listed)
- ASA I-II, who speaks and writes Turkish
Key exclusion criteria (1 listed)
- psychiatric illness
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 mediaASA I-II, who speaks and writes Turkish and do not have psychiatric illness patients will attend the study. | Behavioural | pregnant patients |
Primary outcome
social media effect on the anesthesia choice
Time frame: were performed before the operation when the patient hospitalized.
the effect of the uncontrolled disinformation on the patients decision of the anesthesia
social media and patient anxiety about anesthesia and surgery
Time frame: before the operation when the patient hospitalized.
anxiety will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 25712127Asiodu IV, Waters CM, Dailey DE, Lee KA, Lyndon A. Breastfeeding and use of social media among first-time African American mothers. J Obstet Gynecol Neonatal Nurs. 2015 Mar-Apr;44(2):268-78. doi: 10.1111/1552-6909.12552. Epub 2015 Feb 24.
- Background: PubMed 30606628Gleeson DM, Craswell A, Jones CM. Women's use of social networking sites related to childbearing: An integrative review. Women Birth. 2019 Aug;32(4):294-302. doi: 10.1016/j.wombi.2018.10.010. Epub 2018 Dec 31.
- Background: PubMed 25665177Holtz B, Smock A, Reyes-Gastelum D. Connected Motherhood: Social Support for Moms and Moms-to-Be on Facebook. Telemed J E Health. 2015 May;21(5):415-21. doi: 10.1089/tmj.2014.0118. Epub 2015 Feb 9.
- Background: PubMed 31222601Pretorius K, Johnson KE, Rew L. An Integrative Review: Understanding Parental Use of Social Media to Influence Infant and Child Health. Matern Child Health J. 2019 Oct;23(10):1360-1370. doi: 10.1007/s10995-019-02781-w.
- Background: PubMed 26779108Barello S, Triberti S, Graffigna G, Libreri C, Serino S, Hibbard J, Riva G. eHealth for Patient Engagement: A Systematic Review. Front Psychol. 2016 Jan 8;6:2013. doi: 10.3389/fpsyg.2015.02013. eCollection 2015.
- Background: PubMed 28886563Field T. Prenatal anxiety effects: A review. Infant Behav Dev. 2017 Nov;49:120-128. doi: 10.1016/j.infbeh.2017.08.008. Epub 2017 Sep 5.
- Background: PubMed 8369244Perkin MR, Bland JM, Peacock JL, Anderson HR. The effect of anxiety and depression during pregnancy on obstetric complications. Br J Obstet Gynaecol. 1993 Jul;100(7):629-34. doi: 10.1111/j.1471-0528.1993.tb14228.x.
- Background: PubMed 32265432Che YJ, Gao YL, Jing J, Kuang Y, Zhang M. Effects of an Informational Video About Anesthesia on Pre- and Post-Elective Cesarean Section Anxiety and Recovery: A Randomized Controlled Trial. Med Sci Monit. 2020 Apr 8;26:e920428. doi: 10.12659/MSM.920428.
- 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.
namık nebi ozcan study chair
Ankara City Hospital Bilkent
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 Regional Anesthesia and Anxiety, run by Ankara City Hospital Bilkent 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 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
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?
social media effect on the anesthesia choice (time frame: were performed before the operation when the patient hospitalized.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05416541, which also lists 8 linked publications.
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 8 Feb 2023.