Fear of Childbirth - Comparison of Two Treatment Options: Internet Given Behavioral Therapy and Counseling by Midwife- a Clinical Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Level of childbirth related fear (FOBS)
研究概览
简要总结
Childbirth related fear is a public health issue strongly related to subsequent reproduction, a request for caesarean section and women's and children's health. Currently, women are offered 3-5 counseling sessions with specially trained midwives and obstetricians in most Swedish hospitals as standard care (SC). In general, women are satisfied with counseling but research show no major effect on cesarean section rates neither in decreased level of childbirth related fear. It is therefore important to find the best available treatment for this issue.
The aim of this program is to compare Internet given cognitive behavior therapy (ICBT) with standard counseling care for pregnant women reporting childbirth related fear.
Research questions: What effect does ICBT compared to SC have on a) the level of childbirth related fear b) a request for cesarean section c) compliance and satisfaction with treatment.
Design: A randomized controlled trial of women reporting childbirth related fear during pregnancy. One arm will receive SC and one arm ICBT though the U-CARE platform. Follow up of given treatment will occur at 30 and 36 weeks of pregnancy, two months and one year after birth. Intervention: The intervention will focus on management of childbirth related fear. This means that the participants do weekly sessions and homework assignments during pregnancy.
Primary outcome will be level of childbirth related fear measured at 36 weeks of pregnancy.
Secondary outcomes are level of childbirth related fear at 2 months and one year after birth, preferences for mode of birth, request for elective cesarean section, compliance and satisfaction with treatment and costs.
Expected benefits: This study will contribute to the development of new treatment methods for childbirth related fear. Evidence of the best treatment to reduce childbirth related fear based on the results from this study could be implemented in clinical practice and hopefully decreases the numbers of cesarean sections without medical indications.
详细描述
Project area
Childbirth related fear is a public health issue strongly related to subsequent reproduction and women's and children's health. It could be assumed that previous negative birth experiences are caused by interventions and/or lack of support from staff during birth which in turn could be linked to women's emotional wellbeing. Childbirth related fear often involves a request for a caesarean section, which in turn could have short and long term consequences for women's and children's health. The majority of studies on childbirth related fear have focused on maternal characteristics and the reasons for childbirth fear. Fewer studies have addressed treatment options for curing childbirth fear. Standard care for women with childbirth related fear in Sweden, is usually counseling with midwives and sometimes this counseling leads to an elective caesarean section. In general, women are satisfied with counselling. However, research shows no major effect of counselling, neither in decreased numbers of cesarean sections on maternal request nor in decreased levels of childbirth related fear one year after birth. Today a substantial financial amount of the budget for women's health care is allocated to treatment of childbirth fear using counselling teams. The introduction of such counseling teams was introduced without being preceded by any randomized trials about its effects. In other areas of health care, cognitive behavior therapy is recommended for psychosocial issues. The present project will compare Internet based cognitive behavior therapy (iCBT) with standard care (SC).
Survey of the field Childbirth related fear has gained major research interest particularly in the Scandinavian countries.Severe fear of childbirth has been reported to 6-10% in a Finish study, and fear comparable to PTSD 1.3%. Measures of childbirth related fear: The FOBS scale was developed in a cross-cultural comparative study where two VAS scales (measuring worries and fears in relation to childbirth) were combined.
Reported reasons for fear of childbirth are; fear of pain, childhood abuse, and feelings that the woman or the baby will be damaged during birth or even die, being denied help from caregivers or felt badly treated by delivery staff and, for multiparous women previous emergency caesarean sections or previous negative experiences of birth.
Treatment for childbirth fear Most Swedish hospitals have special counseling teams for women with childbirth fear, often called Aurora groups. Their antenatal midwife refers women to these special teams. The most common treatment model for these women are visits with a specially trained midwife, but psycho-somatic support, cognitive behavior therapy, and relaxation techniques are also used. This counseling treatment in Sweden has not been preceded by large randomized studies, but studies indicate that women are satisfied with the treatment. It has also been shown that women who are referred to the Aurora services more frequently have caesarean sections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mastery of the Swedish language,
- •FOBS above 60,
- •internet access
排除标准
- 未提供
研究组 & 干预措施
Therapy by iCBT
Internet Cognitive behavioral therapy (iCBT) is given by a psychologist in the U-CARE platform. The intervention will focus on management of childbirth related fear. This means that the participants read texts and do homework assignments instructed from an internet page. Additional resources such as pictures, animations, videos and sounds will be a part of the treatment program. A psychologist will communicate with the participants through internal text-messages and will give feed back on their home work assignments. The content of the intervention will be standard components from CBT, for example relaxation training, behavioral activation, exposure for fear related stimuli, cognitive restructuring, behavioral sleep treatment.
干预措施: Therapy by iCBT (Behavioral)
Standard care-Counselling
Counselling for childbirth fear is given by the antenatal care midwife and by specially trained midwives working in collaboration with obstetricians at approximately 3-5 face to face counselling sessions. Often a visit to the delivery unit is included in the program and a care plan for the coming birth.
干预措施: Standard care-counselling (Other)
结局指标
主要结局
Level of childbirth related fear (FOBS)
时间窗: 36 weeks of gestation
Level of childbirth related fear
次要结局
- Request for cesarean section (yes or no)(1 year postpartum)
- Preferred mode of birth (vaginal or cesarean section)(36 weeks of gestation)
- Level of childbirth related fear (FOBS)(1 year post-partum)
