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临床试验/NCT04300725
NCT04300725已完成不适用

Video Counseling: A Randomized Control Trial Comparing Video Counseling and Verbal Counseling in Patients Undergoing an Induction of Labor.

University of Louisville2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
Counseling

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Single (Care Provider)

盲法说明

• 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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients undergoing an induction of labor who do not read, understand, or speak English.
  • Patients undergoing an induction of labor less than age
  • Any patients who is admitted under a certified nurse midwife will not be eligible to participate.

结局指标

主要结局

Counseling

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin Marques

Assistant Professor Department of Obstetrics, Gynecology and Women's Health

University of Louisville

研究点 (2)

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