KnowledgeNCT04537260
An Educational Video's Impact on the Induction of Labor Experience
A study testing Educational Video in people with Knowledge and Satisfaction, Patient, run by George Washington University at 1 site in United States.
Trial summary
The investigators have created a brief, 3-minute video that discusses the induction of labor process. The aim of this study is to evaluate, via a randomized method, how this educational video impact's patients' knowledge and satisfaction with the induction of labor process. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Satisfaction, Patient
- What is being tested?
- Educational Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 29 Feb 2020
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- English speaking
- Scheduled for induction of labor at the George Washington University Hospital
Who cannot join
- < 18 years of age
- Does not speak English
- Not scheduled for an induction of labor
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: How Will an Educational Video About the Induction of Labor Process Impact Patient's Knowledge of and Satisfaction With the Induction Process
The investigators have created a brief, 3-minute video that discusses the induction of labor process. The aim of this study is to evaluate, via a randomized method, how this educational video impact's patients' knowledge and satisfaction with the induction of labor process.
Purpose: Evaluate how an educational video impacts patients' knowledge and satisfaction with the induction of labor process
Read more
Research questions:
- Does a brief educational video improve patients' baseline knowledge of the induction of labor process when compared to patients' who receive traditional care?
- Does a brief educational video improve patients' overall satisfaction with their delivery course when compared to patients' who received the standard care? Hypothesis: Those patients' shown a brief educational video will have a higher baseline knowledge about the induction process and higher satisfaction with their delivery course compared to patients who received the standard in-office counseling.
Read the detailed description
Recruitment and Data Collection:
Patients were screened for study enrollment during routine prenatal visits at the George Washington University Hospital. A trained research team member met with and spoke to eligible patients about the randomized study at the time of their scheduled induction of labor visit. There was an induction of labor schedule that is created monthly, which the research team members had access to and determined when eligible participants had their induction of labor visit scheduled.
Informed consent was obtained from the patient if they were interested in participating. Privacy and confidentiality were assured as approved team members were the only individuals with access to patient records and maintained strict confidentiality. All consent forms were kept in a locked cabinet and survey responses were de-identified. Patients were able to ask questions and/or opt out of the study at any time.
The research team member assessed patient's understanding of the information and participation by asking them to describe in their own words what they were consenting to. Signed informed consent were obtained prior to study enrollment.
Once a patient was enrolled, they were randomized to the control group (no intervention) or the intervention group (3-minute educational video intervention). The randomization schedule was predetermined. The enrolled participant was given a pre-randomized study envelope that contained a unique Study ID number, randomization group, and paper surveys.
The control group took the knowledge-based survey. Twenty-four to forty-eight hours after delivery, at a time convenient to the participant during the postpartum stay at GW, a research team member asked the participant to fill out a second survey, focused on satisfaction with the labor and delivery process.
The intervention group had the opportunity to watch the 3-minute educational video. The video shown to these participants is linked here: https://youtu.be/Pc9tcIV4Dm8. After watching the video, the participant was asked to take the knowledge-based survey. Twenty-four to forty-eight hours after delivery, at a time convenient to the participant during the postpartum stay at GW, a research team member asked the participant to fill out a second survey, focused on satisfaction.
If the patient ultimately chose not to participate in the study following the signing of informed consent, all their data was destroyed. All of the surveys were stored in a locked cabinet, secured. No one but the research team members had access to the collected data and none of the stored paper copies had any identifying information. The basic demographic information, as well as the outcome of the induction of labor process, was collected using the hospital's electronic medical record. Some of the information (race and ethnicity) was collected by self-report. Emails were obtained by self-report on a voluntary basis. They were only collected if patients wished to be entered into the raffle for the Amazon gift card.
Recruitment goal:
At minimum, the goal was an n= of 106 total, 53 per arm. This was powered based on an alpha of 0.05, 80% power, 10% attrition rate to accurately detect a 20% difference given 96% correct in the intervention group.
Data entry:
After enrollment and completion of study surveys, a member of the research team entered in all of the information collected into a de-identified Redcap database using the unique Study ID numbers. The research team also collected data from the patient's electronic medical record about the enrolled participant's induction of labor process, including gravity, parity, pregnancy complications, induction agents utilized, and delivery method (vaginal vs cesarean delivery). All of this data was entered into the de-identified Redcap database. Access to the participant's medical record was only available to the research team through the MFA's HIPAA compliant, password protected, firewalled electronic medical record (Allscripts) and GW hospitals' EMR (Cerner).
After the data was entered into Redcap, a second and different member of the research team re-checked the entry to ensure the answers were correctly captured into the system.
Statistical Analysis:
The investigators used specific methods to address our hypothesis: Those patients' shown a brief educational video will have a higher baseline knowledge about the induction process and higher satisfaction with their delivery course compared to patients who received the standard in-office counseling.
- Does a brief educational video improve patients' baseline knowledge of the induction of labor process when compared to patients' who receive the traditional care? The investigators used mean, standard deviation, and analysis via Mann-Whitney U tests.
- Does a brief educational video improve patients' overall satisfaction with their delivery course when compared to patients' who received the standard care?
The investigators used mean, standard deviation, and analysis via Mann-Whitney U, Chi-Square, and Fisher's exact tests.
- Conditions
- Knowledge, Satisfaction, Patient
- Being tested
- Educational Video
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational VideoBehavioural
Those in the intervention arm were asked to watch the 3-minute educational video prior to the knowledge questionnaire and meeting their provider (midwife or obstetrician). The video shown to these participants is linked here: https://youtu.be/Pc9tcIV4Dm8.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (Standard of Care) | No intervention | The control group took the knowledge-based survey about induction of labor prior to meeting their provider (midwife or obstetrician) on the day of scheduled induction. Twenty-four to forty-eight hours after delivery, at a time convenient to the participant during the postpartum stay at GW, a research team member asked the participant to fill out a second survey, focused on satisfaction with the labor and delivery process. |
| Intervention Arm (Educational video) | Experimental | The intervention group had the opportunity to watch the 3-minute educational video. The video shown to these participants is linked here: https://youtu.be/Pc9tcIV4Dm8. After watching the video, the participant was asked to take the knowledge-based survey. Twenty-four to forty-eight hours after delivery, at a time convenient to the participant during the postpartum stay at GW, a research team member asked the participant to fill out a second survey, focused on satisfaction. Receives: Behavioral: Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Induction of Labor
Evaluating if a 3-minute educational video changes patients' baseline knowledge of the induction of labor process when compared to patients' who receive traditional care via a questionnaire.
Measured: 3 minute knowledge based questionnaire given to both arms prior to meeting with a provider (midwife or obstetrician).
Secondary outcomes (1)
Satisfaction with Induction of Labor Process
Evaluating if a 3-minute educational video changes patients' overall satisfaction with their delivery course when compared to patients' who received the standard care via a questionnaire.
Measured: 3 minute satisfaction questionnaire given to both arms 24 to 48 hours after delivery at a time convenient for them.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Oct 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KnowledgeStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were either enrolled in the control arm (no intervention) or the intervention group (3-minute educational video intervention)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara H Rahman, MD, Study director, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537260
- Sponsor's protocol ID
- NCR191281
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rahman S, Kripalani S, Keegan E, Sparks A, Amdur R, Moawad G, Sheth S, Klebanoff J. An educational video's impact on the induction of labor experience: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100495. doi: 10.1016/j.ajogmf.2021.100495. Epub 2021 Sep 24.
PubMed 34571210
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Will an Educational Video About the Induction of Labor Process Impact Patient's Knowledge of and Satisfaction With the Induction Process
- ClinicalTrials.gov ID
- NCT04537260
- Acronym / sponsor ID
- NCR191281
- Conditions
- Knowledge, Satisfaction, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 3 Sep 2020 (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 investigators have created a brief, 3-minute video that discusses the induction of labor process. The aim of this study is to evaluate, via a randomized method, how this educational video impact's patients' knowledge and satisfaction with the induction of labor process.
Purpose: Evaluate how an educational video impacts patients' knowledge and satisfaction with the induction of labor process
Research questions:
- Does a brief educational video improve patients' baseline knowledge of the induction of labor process when compared to patients' who receive traditional care?
- Does a brief educational video improve patients' overall satisfaction with their delivery course when compared to patients' who received the standard care? Hypothesis: Those patients' shown a brief educational video will have a higher baseline knowledge about the induction process and higher satisfaction with their delivery course compared to patients who received the standard in-office counseling.
Detailed description
Recruitment and Data Collection:
Patients were screened for study enrollment during routine prenatal visits at the George Washington University Hospital. A trained research team member met with and spoke to eligible patients about the randomized study at the time of their scheduled induction of labor visit. There was an induction of labor schedule that is created monthly, which the research team members had access to and determined when eligible participants had their induction of labor visit scheduled.
Informed consent was obtained from the patient if they were interested in participating. Privacy and confidentiality were assured as approved team members were the only individuals with access to patient records and maintained strict confidentiality. All consent forms were kept in a locked cabinet and survey responses were de-identified. Patients were able to ask questions and/or opt out of the study at any time.
The research team member assessed patient's understanding of the information and participation by asking them to describe in their own words what they were consenting to. Signed informed consent were obtained prior to study enrollment.
Once a patient was enrolled, they were randomized to the control group (no intervention) or the intervention group (3-minute educational video intervention). The randomization schedule was predetermined. The enrolled participant was given a pre-randomized study envelope that contained a unique Study ID number, randomization group, and paper surveys.
The control group took the knowledge-based survey. Twenty-four to forty-eight hours after delivery, at a time convenient to the participant during the postpartum stay at GW, a research team member asked the participant to fill out a second survey, focused on satisfaction with the labor and delivery process.
The intervention group had the opportunity to watch the 3-minute educational video. The video shown to these participants is linked here: https://youtu.be/Pc9tcIV4Dm8. After watching the video, the participant was asked to take the knowledge-based survey. Twenty-four to forty-eight hours after delivery, at a time convenient to the participant during the postpartum stay at GW, a research team member asked the participant to fill out a second survey, focused on satisfaction.
If the patient ultimately chose not to participate in the study following the signing of informed consent, all their data was destroyed. All of the surveys were stored in a locked cabinet, secured. No one but the research team members had access to the collected data and none of the stored paper copies had any identifying information. The basic demographic information, as well as the outcome of the induction of labor process, was collected using the hospital's electronic medical record. Some of the information (race and ethnicity) was collected by self-report. Emails were obtained by self-report on a voluntary basis. They were only collected if patients wished to be entered into the raffle for the Amazon gift card.
Recruitment goal:
At minimum, the goal was an n= of 106 total, 53 per arm. This was powered based on an alpha of 0.05, 80% power, 10% attrition rate to accurately detect a 20% difference given 96% correct in the intervention group.
Data entry:
After enrollment and completion of study surveys, a member of the research team entered in all of the information collected into a de-identified Redcap database using the unique Study ID numbers. The research team also collected data from the patient's electronic medical record about the enrolled participant's induction of labor process, including gravity, parity, pregnancy complications, induction agents utilized, and delivery method (vaginal vs cesarean delivery). All of this data was entered into the de-identified Redcap database. Access to the participant's medical record was only available to the research team through the MFA's HIPAA compliant, password protected, firewalled electronic medical record (Allscripts) and GW hospitals' EMR (Cerner).
After the data was entered into Redcap, a second and different member of the research team re-checked the entry to ensure the answers were correctly captured into the system.
Statistical Analysis:
The investigators used specific methods to address our hypothesis: Those patients' shown a brief educational video will have a higher baseline knowledge about the induction process and higher satisfaction with their delivery course compared to patients who received the standard in-office counseling.
- Does a brief educational video improve patients' baseline knowledge of the induction of labor process when compared to patients' who receive the traditional care? The investigators used mean, standard deviation, and analysis via Mann-Whitney U tests.
- Does a brief educational video improve patients' overall satisfaction with their delivery course when compared to patients' who received the standard care?
The investigators used mean, standard deviation, and analysis via Mann-Whitney U, Chi-Square, and Fisher's exact tests.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were either enrolled in the control arm (no intervention) or the intervention group (3-minute educational video intervention)
| Arm | Type | Receives |
|---|---|---|
| Control Arm (Standard of Care) | No intervention | –The control group took the knowledge-based survey about induction of labor prior to meeting their provider (midwife or obstetrician) on the day of scheduled induction. Twenty-four to forty-eight hours after delivery, at a time convenient to the participant during the postpartum stay at GW, a research team member asked the participant to fill out a second survey, focused on satisfaction with the labor and delivery process. |
| Intervention Arm (Educational video) | Experimental | Behavioral: Educational VideoThe intervention group had the opportunity to watch the 3-minute educational video. The video shown to these participants is linked here: https://youtu.be/Pc9tcIV4Dm8. After watching the video, the participant was asked to take the knowledge-based survey. Twenty-four to forty-eight hours after delivery, at a time convenient to the participant during the postpartum stay at GW, a research team member asked the participant to fill out a second survey, focused on satisfaction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- English speaking
- Scheduled for induction of labor at the George Washington University Hospital
Key exclusion criteria (3 listed)
- < 18 years of age
- Does not speak English
- Not scheduled for an induction of labor
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 |
|---|---|---|
| Educational VideoThose in the intervention arm were asked to watch the 3-minute educational video prior to the knowledge questionnaire and meeting their provider (midwife or obstetrician). The video shown to these participants is linked here: https://youtu.be/Pc9tcIV4Dm8. | Behavioural | Intervention Arm (Educational video) |
Primary outcome
Knowledge of Induction of Labor
Time frame: 3 minute knowledge based questionnaire given to both arms prior to meeting with a provider (midwife or obstetrician).
Evaluating if a 3-minute educational video changes patients' baseline knowledge of the induction of labor process when compared to patients' who receive traditional care via a questionnaire.
1 secondary outcome
Satisfaction with Induction of Labor Process
Time frame: 3 minute satisfaction questionnaire given to both arms 24 to 48 hours after delivery at a time convenient for them.
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 3 Sep 2020.
- Derived from this study: PubMed 34571210Rahman S, Kripalani S, Keegan E, Sparks A, Amdur R, Moawad G, Sheth S, Klebanoff J. An educational video's impact on the induction of labor experience: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100495. doi: 10.1016/j.ajogmf.2021.100495. Epub 2021 Sep 24.
- 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.
Sara H Rahman, MD study director
Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video in people with Knowledge and Satisfaction, Patient, run by George Washington University at 1 site in United States.
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 3 inclusion and 3 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 3 Sep 2020. 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 United States. 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?
Knowledge of Induction of Labor (time frame: 3 minute knowledge based questionnaire given to both arms prior to meeting with a provider (midwife or obstetrician).). 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 NCT04537260, which also lists 1 linked publication.
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 3 Sep 2020.