当前位置: X-MOL 学术Trials › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Postpartum Early EMDR therapy Intervention (PERCEIVE) study for women after a traumatic birth experience: study protocol for a randomized controlled trial
Trials ( IF 2.5 ) Pub Date : 2021-09-06 , DOI: 10.1186/s13063-021-05545-6
Y M G A Hendrix 1 , K S M van Dongen 1 , A de Jongh 2, 3, 4, 5, 6 , M G van Pampus 1
Affiliation  

Up to 33% of women develop symptoms of posttraumatic stress disorder (PTSD) after a traumatic birth experience. Negative and traumatic childbirth experiences can also lead to fear of childbirth, avoiding or negatively influencing a subsequent pregnancy, mother-infant bonding problems, problems with breastfeeding, depression and reduced quality of life. For PTSD in general, eye movement desensitization and reprocessing (EMDR) therapy has proven to be effective. However, little is known about the preventive effects of early intervention EMDR therapy in women after a traumatic birth experience. The purpose of this study is to determine the effectiveness of early intervention EMDR therapy in preventing PTSD and reducing PTSD symptoms in women with a traumatic birth experience. The PERCEIVE study is a randomized controlled trial. Women suffering from the consequences of a traumatic birth experience will be randomly allocated at maximum 14 days postpartum to either EMDR therapy or ‘care-as-usual’. Patients in the EMDR group receive two sessions of therapy between 14 (T0) and 35 days postpartum. All participants will be assessed at T0 and at 9 weeks postpartum (T1). At T1, all participants will undergo a CAPS-5 interview about the presence and severity of PTSD symptoms. The primary outcome measure is the severity of PTSD symptoms, whereas the secondary outcomes pertain to fear of childbirth, mother-infant bonding, breastfeeding, depression and quality of life. The study will be conducted at a large city hospital and at multiple midwifery practices in Amsterdam, the Netherlands. It is to be expected that the results of this study will provide more insight about the safety and effectiveness of early intervention EMDR therapy in the prevention and reduction of PTSD (symptoms) in women with a traumatic birth experience. Netherlands Trial Register NL73231.000.20 . Registered on 21 August 2020.

中文翻译:

产后早期 EMDR 治疗干预 (PERCEIVE) 研究针对经历过创伤性分娩经历的女性:随机对照试验的研究方案

多达 33% 的女性在经历创伤性分娩后会出现创伤后应激障碍 (PTSD) 的症状。负面和创伤性的分娩经历也会导致对分娩的恐惧、避免或负面影响随后的怀孕、母婴关系问题、母乳喂养问题、抑郁和生活质量下降。对于一般的 PTSD,眼动脱敏和再处理 (EMDR) 疗法已被证明是有效的。然而,关于早期干预 EMDR 治疗对经历创伤性分娩经历的女性的预防效果知之甚少。本研究的目的是确定早期干预 EMDR 治疗在预防 PTSD 和减少有创伤性分娩经历的女性的 PTSD 症状方面的有效性。PERCEIVE 研究是一项随机对照试验。遭受创伤性分娩经历后果的妇女将在产后最多 14 天被随机分配到 EMDR 治疗或“照常护理”。EMDR 组的患者在产后 14 (T0) 和 35 天之间接受两次治疗。所有参与者将在 T0 和产后 9 周 (T1) 进行评估。在 T1,所有参与者将接受关于 PTSD 症状的存在和严重程度的 CAPS-5 访谈。主要结果衡量指标是 PTSD 症状的严重程度,而次要结果涉及对分娩的恐惧、母婴关系、母乳喂养、抑郁和生活质量。该研究将在荷兰阿姆斯特丹的一家大型城市医院和多家助产士诊所进行。预计这项研究的结果将提供更多关于早期干预 EMDR 治疗在预防和减少有创伤性分娩经历的女性 PTSD(症状)方面的安全性和有效性的见解。荷兰试验注册 NL73231.000.20。2020 年 8 月 21 日注册。
更新日期:2021-09-06
down
wechat
bug