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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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:

  1. Does a brief educational video improve patients' baseline knowledge of the induction of labor process when compared to patients' who receive traditional care?
  2. 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.

  1. 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.
  2. 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.

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 groups in NCT04537260
Study groupRoleWhat they receive
Control Arm (Standard of Care)No interventionThe 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)ExperimentalThe 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.

  1. 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)
  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.

  1. First posted3 Sep 2020
  2. Study start1 Oct 2019
  3. Primary completion29 Feb 2020
  4. Study completion29 Feb 2020

Resources

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)
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

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.

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