NCT04300725

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

February 25, 2020

Last Update Submit

April 6, 2021

Conditions

Keywords

Induction of LaborVideo Counseling

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 1 year

Study Arms (2)

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.

Other: Video Counseling

Interventions

Patients in the other study arm receive verbal + video counseling prior to their induction of labor.

Video Counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerisity of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Related Publications (15)

  • 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.

    PMID: 29729857BACKGROUND
  • Wilson 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.

  • Beckmann 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.

  • Winston 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.

  • Davis 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.

  • Staley 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.

  • Weston 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.

  • Greene 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.

  • Farrell 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.

  • Newsom 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.

  • Martin 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.

  • Cartwright A. Mothers' experiences of induction. Br Med J. 1977 Sep 17;2(6089):745-9. doi: 10.1136/bmj.2.6089.745.

  • Nuutila 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.

  • Stewart P. Patients' attitudes to induction and labour. Br Med J. 1977 Sep 17;2(6089):749-52. doi: 10.1136/bmj.2.6089.749.

  • Tong 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
• Randomization will occur after informed written consent has been obtained. Treatment randomization will be performed using a block randomization approach with block sizes of 10 individuals. A list will be created using www.sealedenvelope.com, and these will be placed in numbered envelopes to be opened after patient consent by the intern resident.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Department of Obstetrics, Gynecology and Women's Health

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 9, 2020

Study Start

May 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations