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“连接式剖宫产”:在母婴之间建立虚拟联系以改善母婴分娩体验——一项 PILOT 试验(e-motion-pilot)的研究方案。

'connEcted caesarean section': creating a virtual link between MOthers and their infanTs to ImprOve maternal childbirth experieNce - study protocol for a PILOT trial (e-motion-pilot).

机构信息

Woman-Mother-Child, Lausanne University Hospital, Lausanne, Switzerland

Anesthesiology, Lausanne University Hospital, Lausanne, Switzerland.

出版信息

BMJ Open. 2023 Jun 7;13(6):e065830. doi: 10.1136/bmjopen-2022-065830.

Abstract

INTRODUCTION

One-third of mothers rate their childbirth as traumatic. The prevalence of childbirth-related post-traumatic stress disorder (CB-PTSD) is 4.7%. Skin-to-skin contact is a protective factor against CB-PTSD. However, during a caesarean section (CS), skin-to-skin contact is not always feasible and mothers and infants are often separated. In those cases, there is no validated and available solution to substitute this unique protective factor. Based on the results of studies using virtual reality and head-mounted displays (HMDs) and studies on childbirth experience, we hypothesise that enabling the mother to have a visual and auditory contact with her baby could improve her childbirth experience while she and her baby are separated. To facilitate this connection, we will use a two-dimensional 360° camera filming the baby linked securely to an HMD that the mother can wear during the end of the surgery.

METHODS AND ANALYSIS

This study protocol describes a monocentric open-label controlled pilot trial with minimal risk testing the effects of a visual and auditory contact via an HMD worn by the mother airing a live video of her newborn compared with treatment-as-usual in 70 women after CS. The first 35 consecutive participants will be the control group and will receive the standard care. The next 35 consecutive participants will have the intervention. The primary outcome will be differences in maternal childbirth experience (Childbirth Experience Questionnaire 2) at 1-week postpartum between the intervention and control groups. Secondary outcomes will be CB-PTSD symptoms, birth satisfaction, mother-infant bonding, perceived pain and stress during childbirth, maternal anxiety and depression symptoms, anaesthesiological data and acceptability of the procedure.

ETHICS AND DISSEMINATION

Ethics approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 2022-00215). Dissemination of results will occur via national and international conferences, peer-reviewed journals, public conferences and social media.

TRIAL REGISTRATION NUMBER

NCT05319665.

摘要

简介

三分之一的母亲会对分娩感到创伤。与分娩相关的创伤后应激障碍(CB-PTSD)的患病率为 4.7%。皮肤接触是预防 CB-PTSD 的保护因素。然而,在剖宫产(CS)期间,皮肤接触并不总是可行的,母亲和婴儿经常分开。在这种情况下,没有经过验证和可用的解决方案来替代这种独特的保护因素。基于使用虚拟现实和头戴式显示器(HMD)的研究结果以及关于分娩体验的研究,我们假设使母亲能够与她的婴儿进行视觉和听觉接触可以改善她在与婴儿分离时的分娩体验。为了实现这种联系,我们将使用一台二维 360°摄像机拍摄婴儿的视频,并将其安全链接到 HMD,以便母亲在手术结束时佩戴,从而实现与婴儿的视觉和听觉接触。

方法和分析

本研究方案描述了一项单中心、开放性、对照试验,以最小风险测试通过母亲佩戴的 HMD 观看她新生儿的实时视频进行视觉和听觉接触对 70 名 CS 后妇女的影响,与常规治疗相比。前 35 名连续参与者将是对照组,并接受标准护理。接下来的 35 名连续参与者将进行干预。主要结果是干预组和对照组在产后 1 周时产妇分娩体验(分娩体验问卷 2)的差异。次要结果是 CB-PTSD 症状、出生满意度、母婴联系、分娩时感知到的疼痛和压力、产妇焦虑和抑郁症状、麻醉学数据以及程序的可接受性。

伦理和传播

该研究已获得沃州人类研究伦理委员会的批准(研究编号 2022-00215)。结果将通过全国和国际会议、同行评议期刊、公开会议和社交媒体进行传播。

试验注册号

NCT05319665。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3dc3/10255091/0f66d30d5eab/bmjopen-2022-065830f01.jpg

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