Pregnancy RelatedNCT04300725
Video Counseling: A Randomized Control Trial
A study testing Video Counseling in people with Pregnancy Related, run by University of Louisville at 1 site in United States.
Trial summary
Lack of standardized verbal counseling prior to an induction of labor can leave many patients feeling uninformed and unprepared. The purpose of this blinded, randomized controlled trial was to compare video vs verbal counseling in a cohort of patients undergoing an induction of labor. 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
- Pregnancy Related
- What is being tested?
- Video Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 May 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
- Patients undergoing an induction of labor who read, understand, and speak English.
- Patients undergoing an induction of labor who are age 18 and older.
- Any gestational age undergoing an induction of labor.
Who cannot join
- Patients undergoing an induction of labor who do not read, understand, or speak English.
- Patients undergoing an induction of labor less than age 18.
- Any patients who is admitted under a certified nurse midwife will not be eligible to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerisity of Louisville Hospital
Louisville, Kentucky, 40202
About this study
Official title: Video Counseling: A Randomized Control Trial Comparing Video Counseling and Verbal Counseling in Patients Undergoing an Induction of Labor.
Lack of standardized verbal counseling prior to an induction of labor can leave many patients feeling uninformed and unprepared. The purpose of this blinded, randomized controlled trial was to compare video vs verbal counseling in a cohort of patients undergoing an induction of labor. Here, an 11 minute and 30 second counseling video was created to counsel patients on the finer intricacies of an induction of labor. Patients were randomized to two groups: verbal counseling and video + verbal counseling. Patients were randomized just prior to beginning their induction of labor. After receiving verbal counseling or verbal and video counseling, patients completed a survey analyzing their awareness of the counseling process.
Read the detailed description
This is a Randomized Control Trial where English speaking patients undergoing and induction of labor at the University of Louisville hospital will be randomly assigned to either receive video counseling and verbal counseling or standard verbal counseling alone over the course of 1 year to obtain the desire number of participants. Participants in the video group will also receive standard verbal counseling provided by the resident. Data collection will be Survey based and with use of a lichert scale. Treatment randomization will be performed using a block randomization approach with block sizes of 10 individuals. Random assignments will be made and these will be placed in numbered envelopes to be opened by the intern resident after patient consent is obtained to participate in the study. Eligible participants will be recruited to the study at the time of presentation for their induction of labor. The intern resident will offer them a brief introduction to the project including risks/ benefits to participation and go over the consent process after they have been roomed in a private labor and delivery room. If agreeable to taking part in the study, participants will be given a consent form with an overview of the project with instructions to sign the consent form if agreeable to participating in the study. The intern resident will verbally consent the patient to participate in the study and discuss the study in detail including risks and benefits of participation. All conversations between the subject and co-investigators will take part in the privacy of the patient's labor and delivery room. There will be a short waiting period between the introduction of the study and the patient signing or declining the consent form. This will allow the patient to read the official consent form and ask any remaining questions. After informed consent is obtained, the consent form will be placed in a binder on labor and delivery, to be uploaded into redcap soon thereafter. This binder will be placed in a locked cabinet and only the research personnel identified on this IRB proposal will have access to this cabinet. Those who are randomized to video counseling will watch the counseling video on a portable iPad. This iPad is used for video interpreting on labor and delivery and is on wheels, which will allow for video counseling in any labor and delivery room at any time. This iPad device will be brought to the room by the intern resident. It has already been provided by the Labor and Delivery unit at the University of Louisville hospital. Those randomized to watch the video will watch this video immediately after obtaining consent to participate in the survey. A member of the research team will not be available during the time the patient is viewing the video. It is 10 minutes long. Its content includes introduction to labor and delivery residents, attendings, and staff as well as induction methods, pain control options, expectations for discharge, and common labor and delivery unit protocols including diet and visitors. The video will only be able to viewed by private link to YouTube. This link will be accessible on the iPad homescreen. The video link is as follows: https://www.youtube.com/watch?v=Lbb6E-4iizI. Paper surveys will then be provided to both groups of patients. Surveys will be completed at the exact same time for both groups when official hospital consent is obtained by the resident for cesarean section, vaginal delivery, and blood transfusion. This traditionally occurs after patients have received standard verbal counseling concerning their induction of labor.Those randomized to video counseling will complete the exact survey after completion of the induction of labor video and at the time of official hospital consent. This will ensure both groups of patients are completing the paper survey at the exact same time. Completed surveys and consents will be placed in a binder on labor and delivery in a locked cabinet. The difference in mean cumulative Lichert scores (primary outcome) between the counseling groups will be assessed using the two-sample t-test. Descriptive statistics (sample proportions, mean, standard deviation, etc) will be computed for demographic variables, and comparison between randomization groups will be carried out by chi-squared, Fisher exact, and two-sample t-tests. Linear regression may be used to measure the relationship between demographic variables and counseling experience (primary outcome). Transformations or non-parametrics tests may be used to account for non-normality in response variables. Differences in individual Lichert questions between treatment group may also be run using the t-test or non-parametric Mann-Whitney test. An R Statistical Software will be utilized.
- Conditions
- Pregnancy Related
- Being tested
- Video Counseling
- Keywords
- Induction of Labor, Video Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video CounselingOther
Patients in the other study arm receive verbal + video counseling prior to their induction of labor.
| Study group | Role | What they receive |
|---|---|---|
| Verbal Counseling | No intervention | Patients in one study arm receive only verbal counseling prior to their induction of labor. |
| Video Counseling | Experimental | Patients in other study arm will receive verbal + video counseling prior to their induction of labor. Receives: Other: Video Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counseling
A patient's awareness of counseling of the process of an induction of labor will be evaluated by lichert scale. A score of 5 (maximum) represents "strongly agree" and a score of 1 (minimum) represents "strongly disagree." Higher scores represent more awareness of the counseling process.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 May 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Marques, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300725
- Sponsor's protocol ID
- 19.0271
- Status last verified
- Apr 2021
- First submitted
- 25 Feb 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosaasen N, Mainra R, Kukha-Bryson A, Nhin V, Trivedi P, Shoker A, Wilson J, Padmanabh R, Mansell H. Development of a patient-centered video series to improve education before kidney transplantation. Patient Educ Couns. 2018 Sep;101(9):1624-1629. doi: 10.1016/j.pec.2018.04.014. Epub 2018 Apr 26.
PubMed 29729857Wilson ME, Krupa A, Hinds RF, Litell JM, Swetz KM, Akhoundi A, Kashyap R, Gajic O, Kashani K. A video to improve patient and surrogate understanding of cardiopulmonary resuscitation choices in the ICU: a randomized controlled trial. Crit Care Med. 2015 Mar;43(3):621-9. doi: 10.1097/CCM.0000000000000749.
PubMed 25479118Beckmann M, Cooper C, Pocock D. INFORMed choices: facilitating shared decision-making in health care. Aust N Z J Obstet Gynaecol. 2015 Jun;55(3):294-7. doi: 10.1111/ajo.12343. Epub 2015 Jun 5.
PubMed 26053591Winston K, Grendarova P, Rabi D. Video-based patient decision aids: A scoping review. Patient Educ Couns. 2018 Apr;101(4):558-578. doi: 10.1016/j.pec.2017.10.009. Epub 2017 Oct 18.
PubMed 29102063Davis SA, Carpenter DM, Blalock SJ, Budenz DL, Lee C, Muir KW, Robin AL, Sleath B. A randomized controlled trial of an online educational video intervention to improve glaucoma eye drop technique. Patient Educ Couns. 2019 May;102(5):937-943. doi: 10.1016/j.pec.2018.12.019. Epub 2018 Dec 18.
PubMed 30583913Staley SA, Charm SS, Slough LB, Zerden ML, Morse JE. Prenatal Contraceptive Counseling by Video. South Med J. 2019 Jan;112(1):8-13. doi: 10.14423/SMJ.0000000000000913.
PubMed 30608623Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns. 1997 Mar;30(3):239-45. doi: 10.1016/s0738-3991(96)00968-8.
PubMed 9104380Greene KA, Wyman AM, Scott LA, Hart S, Hoyte L, Bassaly R. Evaluation of patient preparedness for surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Aug;217(2):179.e1-179.e7. doi: 10.1016/j.ajog.2017.04.017. Epub 2017 Apr 18.
PubMed 28431952Farrell RM, Agatisa PK, Mercer MB, Mitchum AG, Coleridge MB. The use of noninvasive prenatal testing in obstetric care: educational resources, practice patterns, and barriers reported by a national sample of clinicians. Prenat Diagn. 2016 Jun;36(6):499-506. doi: 10.1002/pd.4812. Epub 2016 Apr 7.
PubMed 26991091Newsom E, Lee E, Rossi A, Dusza S, Nehal K. Modernizing the Mohs Surgery Consultation: Instituting a Video Module for Improved Patient Education and Satisfaction. Dermatol Surg. 2018 Jun;44(6):778-784. doi: 10.1097/DSS.0000000000001473.
PubMed 29642110Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Mathews TJ, Kirmeyer S, Osterman MJ. Births: final data for 2007. Natl Vital Stat Rep. 2010 Aug 9;58(24):1-85.
PubMed 21254725Cartwright A. Mothers' experiences of induction. Br Med J. 1977 Sep 17;2(6089):745-9. doi: 10.1136/bmj.2.6089.745.
PubMed 912282Nuutila M, Halmesmaki E, Hiilesmaa V, Ylikorkala O. Women's anticipations of and experiences with induction of labor. Acta Obstet Gynecol Scand. 1999 Sep;78(8):704-9.
PubMed 10468063Stewart P. Patients' attitudes to induction and labour. Br Med J. 1977 Sep 17;2(6089):749-52. doi: 10.1136/bmj.2.6089.749.
PubMed 912283Tong CT, Mackeen AD, Berghella V. The effect of standardized counseling on patient knowledge about induction of labor. J Matern Fetal Neonatal Med. 2012 Dec;25(12):2700-3. doi: 10.3109/14767058.2012.703726. Epub 2012 Jul 13.
PubMed 22708706
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Counseling: A Randomized Control Trial Comparing Video Counseling and Verbal Counseling in Patients Undergoing an Induction of Labor.
- ClinicalTrials.gov ID
- NCT04300725
- Acronym / sponsor ID
- 19.0271
- Conditions
- Pregnancy Related
- Keywords
- Induction of Labor, Video Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 9 Mar 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.
Lack of standardized verbal counseling prior to an induction of labor can leave many patients feeling uninformed and unprepared. The purpose of this blinded, randomized controlled trial was to compare video vs verbal counseling in a cohort of patients undergoing an induction of labor. Here, an 11 minute and 30 second counseling video was created to counsel patients on the finer intricacies of an induction of labor. Patients were randomized to two groups: verbal counseling and video + verbal counseling. Patients were randomized just prior to beginning their induction of labor. After receiving verbal counseling or verbal and video counseling, patients completed a survey analyzing their awareness of the counseling process.
Detailed description
This is a Randomized Control Trial where English speaking patients undergoing and induction of labor at the University of Louisville hospital will be randomly assigned to either receive video counseling and verbal counseling or standard verbal counseling alone over the course of 1 year to obtain the desire number of participants. Participants in the video group will also receive standard verbal counseling provided by the resident. Data collection will be Survey based and with use of a lichert scale. Treatment randomization will be performed using a block randomization approach with block sizes of 10 individuals. Random assignments will be made and these will be placed in numbered envelopes to be opened by the intern resident after patient consent is obtained to participate in the study. Eligible participants will be recruited to the study at the time of presentation for their induction of labor. The intern resident will offer them a brief introduction to the project including risks/ benefits to participation and go over the consent process after they have been roomed in a private labor and delivery room. If agreeable to taking part in the study, participants will be given a consent form with an overview of the project with instructions to sign the consent form if agreeable to participating in the study. The intern resident will verbally consent the patient to participate in the study and discuss the study in detail including risks and benefits of participation. All conversations between the subject and co-investigators will take part in the privacy of the patient's labor and delivery room. There will be a short waiting period between the introduction of the study and the patient signing or declining the consent form. This will allow the patient to read the official consent form and ask any remaining questions. After informed consent is obtained, the consent form will be placed in a binder on labor and delivery, to be uploaded into redcap soon thereafter. This binder will be placed in a locked cabinet and only the research personnel identified on this IRB proposal will have access to this cabinet. Those who are randomized to video counseling will watch the counseling video on a portable iPad. This iPad is used for video interpreting on labor and delivery and is on wheels, which will allow for video counseling in any labor and delivery room at any time. This iPad device will be brought to the room by the intern resident. It has already been provided by the Labor and Delivery unit at the University of Louisville hospital. Those randomized to watch the video will watch this video immediately after obtaining consent to participate in the survey. A member of the research team will not be available during the time the patient is viewing the video. It is 10 minutes long. Its content includes introduction to labor and delivery residents, attendings, and staff as well as induction methods, pain control options, expectations for discharge, and common labor and delivery unit protocols including diet and visitors. The video will only be able to viewed by private link to YouTube. This link will be accessible on the iPad homescreen. The video link is as follows: https://www.youtube.com/watch?v=Lbb6E-4iizI. Paper surveys will then be provided to both groups of patients. Surveys will be completed at the exact same time for both groups when official hospital consent is obtained by the resident for cesarean section, vaginal delivery, and blood transfusion. This traditionally occurs after patients have received standard verbal counseling concerning their induction of labor.Those randomized to video counseling will complete the exact survey after completion of the induction of labor video and at the time of official hospital consent. This will ensure both groups of patients are completing the paper survey at the exact same time. Completed surveys and consents will be placed in a binder on labor and delivery in a locked cabinet. The difference in mean cumulative Lichert scores (primary outcome) between the counseling groups will be assessed using the two-sample t-test. Descriptive statistics (sample proportions, mean, standard deviation, etc) will be computed for demographic variables, and comparison between randomization groups will be carried out by chi-squared, Fisher exact, and two-sample t-tests. Linear regression may be used to measure the relationship between demographic variables and counseling experience (primary outcome). Transformations or non-parametrics tests may be used to account for non-normality in response variables. Differences in individual Lichert questions between treatment group may also be run using the t-test or non-parametric Mann-Whitney test. An R Statistical Software will be utilized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal Counseling | No intervention | –Patients in one study arm receive only verbal counseling prior to their induction of labor. |
| Video Counseling | Experimental | Other: Video CounselingPatients in other study arm will receive verbal + video counseling prior to their induction of labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing an induction of labor who read, understand, and speak English.
- Patients undergoing an induction of labor who are age 18 and older.
- Any gestational age undergoing an induction of labor.
Key exclusion criteria (3 listed)
- Patients undergoing an induction of labor who do not read, understand, or speak English.
- Patients undergoing an induction of labor less than age 18.
- Any patients who is admitted under a certified nurse midwife will not be eligible to participate.
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 |
|---|---|---|
| Video CounselingPatients in the other study arm receive verbal + video counseling prior to their induction of labor. | Other | Video Counseling |
Primary outcome
Counseling
Time frame: Up to 1 year
A patient's awareness of counseling of the process of an induction of labor will be evaluated by lichert scale. A score of 5 (maximum) represents "strongly agree" and a score of 1 (minimum) represents "strongly disagree." Higher scores represent more awareness of the counseling process.
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 8 Apr 2021.
- Background: PubMed 29729857Rosaasen N, Mainra R, Kukha-Bryson A, Nhin V, Trivedi P, Shoker A, Wilson J, Padmanabh R, Mansell H. Development of a patient-centered video series to improve education before kidney transplantation. Patient Educ Couns. 2018 Sep;101(9):1624-1629. doi: 10.1016/j.pec.2018.04.014. Epub 2018 Apr 26.
- Results publication: PubMed 25479118Wilson ME, Krupa A, Hinds RF, Litell JM, Swetz KM, Akhoundi A, Kashyap R, Gajic O, Kashani K. A video to improve patient and surrogate understanding of cardiopulmonary resuscitation choices in the ICU: a randomized controlled trial. Crit Care Med. 2015 Mar;43(3):621-9. doi: 10.1097/CCM.0000000000000749.
- Results publication: PubMed 26053591Beckmann M, Cooper C, Pocock D. INFORMed choices: facilitating shared decision-making in health care. Aust N Z J Obstet Gynaecol. 2015 Jun;55(3):294-7. doi: 10.1111/ajo.12343. Epub 2015 Jun 5.
- Results publication: PubMed 29102063Winston K, Grendarova P, Rabi D. Video-based patient decision aids: A scoping review. Patient Educ Couns. 2018 Apr;101(4):558-578. doi: 10.1016/j.pec.2017.10.009. Epub 2017 Oct 18.
- Results publication: PubMed 30583913Davis SA, Carpenter DM, Blalock SJ, Budenz DL, Lee C, Muir KW, Robin AL, Sleath B. A randomized controlled trial of an online educational video intervention to improve glaucoma eye drop technique. Patient Educ Couns. 2019 May;102(5):937-943. doi: 10.1016/j.pec.2018.12.019. Epub 2018 Dec 18.
- Results publication: PubMed 30608623Staley SA, Charm SS, Slough LB, Zerden ML, Morse JE. Prenatal Contraceptive Counseling by Video. South Med J. 2019 Jan;112(1):8-13. doi: 10.14423/SMJ.0000000000000913.
- Results publication: PubMed 9104380Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns. 1997 Mar;30(3):239-45. doi: 10.1016/s0738-3991(96)00968-8.
- Results publication: PubMed 28431952Greene KA, Wyman AM, Scott LA, Hart S, Hoyte L, Bassaly R. Evaluation of patient preparedness for surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Aug;217(2):179.e1-179.e7. doi: 10.1016/j.ajog.2017.04.017. Epub 2017 Apr 18.
- Results publication: PubMed 26991091Farrell RM, Agatisa PK, Mercer MB, Mitchum AG, Coleridge MB. The use of noninvasive prenatal testing in obstetric care: educational resources, practice patterns, and barriers reported by a national sample of clinicians. Prenat Diagn. 2016 Jun;36(6):499-506. doi: 10.1002/pd.4812. Epub 2016 Apr 7.
- Results publication: PubMed 29642110Newsom E, Lee E, Rossi A, Dusza S, Nehal K. Modernizing the Mohs Surgery Consultation: Instituting a Video Module for Improved Patient Education and Satisfaction. Dermatol Surg. 2018 Jun;44(6):778-784. doi: 10.1097/DSS.0000000000001473.
- Results publication: PubMed 21254725Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Mathews TJ, Kirmeyer S, Osterman MJ. Births: final data for 2007. Natl Vital Stat Rep. 2010 Aug 9;58(24):1-85.
- Results publication: PubMed 912282Cartwright A. Mothers' experiences of induction. Br Med J. 1977 Sep 17;2(6089):745-9. doi: 10.1136/bmj.2.6089.745.
- 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.
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?
A study testing Video Counseling in people with Pregnancy Related, run by University of Louisville 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 8 Apr 2021. 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?
Counseling (time frame: Up to 1 year). 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 NCT04300725, which also lists 15 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 Apr 2021.