The Effect of Exposure to an Informative Video About Amniocentesis Before the Procedure on Maternal Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessment of change in anxiety levels between before and after undergoing the amniocentesis
研究概览
简要总结
The effect of exposure to an informative video about amniocentesis before the procedure on maternal anxiety
详细描述
Amniocentesis is a common sonography-guided procedure that is usually preformed during the second trimester of pregnancy in order to obtain neonatal genetic information. Previous studies have shown that although the risk of a major complication is small, many women experience profound anxiety regarding the procedure.
Many stress-relieving techniques have been proposed and studied concerning stress-related interventions during pregnancy. However, the use of an informative video that is a simple, accessible, widely accepted tool has not been tested in the context of amniocentesis. In this interventional study the investigators aim to examine the effect of an informative pre-procedural video on anxiety and pain levels in women undergoing amniocentesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data regarding maternal characteristics, anxiety and pain levels as reported by the patients via the questioners will be stored according to random serial numbers without intervention type. The investigator handling the statistical analysis will be unaware of the patient's exposure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who come for amniocentesis in the Edith Wolfson Medical Center
- •Women who sign a consent form to enroll to the study.
排除标准
- •Women under 18 years of age.
- •Women who do not speak Hebrew
结局指标
主要结局
Assessment of change in anxiety levels between before and after undergoing the amniocentesis
时间窗: Each patient will answer the STAI questionnaire twice - within 2 hours before the operation and watching the video (S1) and within 30 minutes after performing amniocentesis (S2) to assess the change in anxiety levels before and after the operation
Women recruited to the study will answer the Spielberger's state-trait anxiety inventory questionnaire- a validated questionnaire for assessing anxiety which includes 20 statements expressing different states of anxiety. The patients will be asked to rate to what extent they currently relate to the statement written on a scale of 1 to 4 (1- does not agree at all and 4- strongly agrees). The final score in each questionnaire is obtained by summing the scores of each statement, while the scores of positive statements reflecting anxiety-free behavior will be reversely summed. Higher scores indicate higher level of anxiety.
次要结局
- Intensity of pain, discomfort, satisfaction with the video and satisfaction in general(The questionnaire will be filled within 30 minutes after performing amniocentesis)