Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04537260
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2020-08-25
Brief Title:
An Educational Videos Impact on the Induction of Labor Experience
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
How Will an Educational Video About the Induction of Labor Process Impact Patients Knowledge of and Satisfaction With the Induction Process
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 impacts 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
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
Purpose Evaluate how an educational video impacts patients knowledge and satisfaction with the induction of labor process
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
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 andor opt out of the study at any time
The research team member assessed patients 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 httpsyoutubePc9tcIV4Dm8 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 hospitals 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 005 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 patients electronic medical record about the enrolled participants 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 participants medical record was only available to the research team through the MFAs 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 Fishers exact tests
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 andor opt out of the study at any time
The research team member assessed patients 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 httpsyoutubePc9tcIV4Dm8 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 hospitals 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 005 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 patients electronic medical record about the enrolled participants 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 participants medical record was only available to the research team through the MFAs 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 Fishers exact tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None