Assess Women Awareness and Fear About EDA for LaborNCT05596604
"Awareness, Preconception, and Fear of Epidural Analgesia Among Childbearing Women in Saudi Arabia."
An observational study of Assess Women Awareness and Fear About EDA for Labor, run by King Khalid University Hospital at 1 site in Saudi Arabia.
Trial summary
The aim of our study is to measure the level of awareness, preconceptions, and level of fear regarding epidural analgesia among childbearing women in KKUH in Riyadh. Read more about this study
- Who is it for?
- Ages 15 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Assess Women Awareness and Fear About EDA for Labor
- How many people
- 202 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2022to 10 Oct 2022
- How long will I take part?
- 1 Day
- 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 15 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: included pregnant women attending an obstetrical clinic for routine antenatal follow-up
Who may be able to join
- pregnant woman
- completing the survey
Who cannot join
- non-pregnant women
- incomplete survey
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to measure the level of awareness, preconceptions, and level of fear regarding epidural analgesia among childbearing women in KKUH in Riyadh.
Read the detailed description
This research was designed as a hospital-based observational cross-sectional study conducted at King Khalid University Hospital, using a self-administered questionnaire based on previous research.22-24-26 approved by the Institutional Review Board at King Saud University, College of Medicine, Riyadh, Saudi Arabia on 08.August.2022 Ref. No. 22/0592/IRB. The sample included pregnant women attending an obstetrical clinic for routine antenatal follow-up, and the data collection was conducted during the month of August 2022. The questionnaire included five parts (sociodemographic, preconception, awareness, fear, and desirability). a total of 26 questions with multiple-choice answers. The sample size was determined using the Comrey and Lee criterion Comrey and Lee (1992) stated that a 200-sample size is acceptable. The questionnaire was completed by 202 participants who met the inclusion criteria that is being a pregnant woman and completing the survey, and the exclusion criteria were non-pregnant women and an incomplete survey. The data collectors made it clear to the participants that taking part in the study was completely optional, and the participants signed anonymous consent forms.
- Being tested
- survey- no intervention
- Keywords
- Awareness, preconception, fear, epidural analgesia, labor pain
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey- no interventionOther
survey- no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness
assess awareness among participants
Measured: month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Aug 2022
- Primary completion29 Aug 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess Women Awareness and Fear About EDA for LaborStudies 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
- 202 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- King Khalid University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud University
- Responsible party
- Principal investigator, Abdulrhman Alshihri, King Khalid University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596604
- Sponsor's protocol ID
- 4361020
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we are not planning to share data
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Awareness, Preconception, and Fear of Epidural Analgesia Among Childbearing Women in Saudi Arabia."
- ClinicalTrials.gov ID
- NCT05596604
- Acronym / sponsor ID
- 4361020
- Keywords
- Awareness, preconception, fear, epidural analgesia, labor pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- King Khalid University HospitalUniversity, hospital or other
- Collaborators
- King Saud University
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 27 Oct 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.
The aim of our study is to measure the level of awareness, preconceptions, and level of fear regarding epidural analgesia among childbearing women in KKUH in Riyadh.
Detailed description
This research was designed as a hospital-based observational cross-sectional study conducted at King Khalid University Hospital, using a self-administered questionnaire based on previous research.22-24-26 approved by the Institutional Review Board at King Saud University, College of Medicine, Riyadh, Saudi Arabia on 08.August.2022 Ref. No. 22/0592/IRB. The sample included pregnant women attending an obstetrical clinic for routine antenatal follow-up, and the data collection was conducted during the month of August 2022. The questionnaire included five parts (sociodemographic, preconception, awareness, fear, and desirability). a total of 26 questions with multiple-choice answers. The sample size was determined using the Comrey and Lee criterion Comrey and Lee (1992) stated that a 200-sample size is acceptable. The questionnaire was completed by 202 participants who met the inclusion criteria that is being a pregnant woman and completing the survey, and the exclusion criteria were non-pregnant women and an incomplete survey. The data collectors made it clear to the participants that taking part in the study was completely optional, and the participants signed anonymous consent forms.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- included pregnant women attending an obstetrical clinic for routine antenatal follow-up
Key inclusion criteria (2 listed)
- pregnant woman
- completing the survey
Key exclusion criteria (2 listed)
- non-pregnant women
- incomplete survey
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 |
|---|---|---|
| survey- no interventionsurvey- no intervention | Other | – |
Primary outcome
Awareness
Time frame: month
assess awareness among participants
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 27 Oct 2022.
- Individual participant dataSharing planned: No. we are not planning to share data
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?
An observational study of Assess Women Awareness and Fear About EDA for Labor, run by King Khalid University Hospital at 1 site in Saudi Arabia.
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 2 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 27 Oct 2022. 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 Saudi Arabia. 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?
Awareness (time frame: month). 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 27 Oct 2022.