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Clinical Trial Summary

Study design This is a randomized controlled trial study with two arms -teach-back group vs. controlled group. Education for Teach-back group and Control group During the trial, women from Teach Back group and controlled group will receive three education sessions arranged by trained nursing supervisors who played the educator role (Table 1). The first education session is arranged at the day or the following day of admission before delivery, with a group meeting involving three women and one educator. The main purpose of the first session is to help women understand and prepare for the labor. The topics discussed at the first session includ delivery mode, labor process and pain relief, newborn health and care (common health issues and care skills), perinatal die and excises, and perinatal psychological health. On the day of discharge after delivery, women will receive the second group education session hosted by an educator. The main purpose of the second session is to help women understand postpartum health issues, get to know the practice of postpartum recovery and learn newborn care skills. The topics discussed at the second session includ postpartum recovery, postpartum maternal health, perineum care (diet, oral care, perineal care, and hygiene), breastfeeding, postpartum blue and depression, neonatal care, neonatal screening tests, newborn vaccination and early child development. At two-week postpartum, a short online meeting will be arranged between one woman and one educator. During the meeting, the educator answer questions raised by the woman and give advices on the challenges and difficulties in postpartum recover and caring newborn faced by the woman. Teach-back group and Control group share same education content and communication methods, e.g. power-point presentation, educational video clips, live demonstration, information booklet, group discussion, and Q&A, expect that before the end of each education session, women in Teach-back group will be asked to use their own words to restate what was just learned and the educator assesses the patient's understanding of the subject, identifies misunderstandings, corrects the mistaken, and provides additional information if required until women can correctly restate what they were expected to learn.


Clinical Trial Description

Intervention Building a health education team, developing protocols and training staff Two obstetric care specialists, eight registered nursing supervisors and two masters-level research nurses comprised a health education team for this study. Obstetric care specialists will be primarily responsible for guiding and monitoring the execution of the intervention. Registered supervisor nurses will organize education sessions for participating women and communicated with women in education sessions. Research nurses will lead the work of designing the study, collected data and conducted analysis, but in order to avoid critical biases in data analysis and interpretation, they do not participate in any education sessions designed in the intervention protocols. Two research nurses approach pregnant women on the day when they are just admitted to hospital for delivery with pregnancies that are considered full term (pregnancy week is between 37+0 and 41+6) but with no sign of labor or getting into the first stage of labor (Women can prefer to stay in hospital as their pregnancies turn full, and wait for delivery). The research nurses ask women to complete a questionnaire designed with perinatal maternal health literacy scale for baseline MHL assessment. Eligible pregnant women will be informed about the aims, contents, and procedures of the study. Participation will be based on voluntary, and informed consent was signed by each participating woman. Before commencing the trial, a one-day team workshop will be organized Building a health education team, developing protocols and training staff Two obstetric care specialists, eight registered nursing supervisors and two masters-level research nurses comprise a health education team for this study. Obstetric care specialists will be primarily responsible for guiding and monitoring the execution of the intervention. Registered supervisor nurses organize education sessions for participating women and communicated with women in education sessions. Research nurses lead the work of designing the study, collected data and conducted analysis, but in order to avoid critical biases in data analysis and interpretation, they do not participate in any education sessions designed in the intervention protocols. Before commencing the trial, a one-day team workshop will organized. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04858945
Study type Interventional
Source Anhui Provincial Hospital
Contact Guizhi Cheng
Phone 15005517549
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date April 15, 2021
Completion date June 27, 2021

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