An Assessment of the Effect of a Brief Psychological Intervention on Decreasing Drop-Out Rates in IVF Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Boston IVF
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Drop out rates
研究概览
简要总结
The most common reason why insured In Vitro Fertilization (IVF) patients drop out of treatment is the distress caused by the treatment.
The objective of this study is to determine the efficacy of a combined Cognitive Coping and Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients.
详细描述
Intervention participants will be given a packet containing the CCRI, which consists of two intervention components tailored to the Stimulation Phase and Waiting Phases of IVF. The cognitive component of the CCRI is the PRCI intervention (Boivin & Lancastle, 2008) tailored to the stimulation/waiting phases of an IVF cycle. The PRCI intervention consists of a series of ten statements that facilitate the use of cognitive reappraisal coping, a form of coping that helps people think more about the positive aspects of a difficult situation and dwell less on problems or uncertainties of the future.
The relaxation components of the CCRI consists of techniques that have been used for two decades in the mind/body infertility program as well as in randomized controlled research trials. For the Stimulation phase, participants will receive instructions on how to do "mini relaxation" techniques which are specifically designed to reduce anxiety in the moment, for example feelings of tension, worry, and nervousness that might occur prior to and during Stimulation phase procedures (e.g. injections, blood tests, and ultrasounds). For the Waiting Phase the relaxation intervention will include a relaxation CD. The CD contains narrated instruction on how to elicit the relaxation response through several techniques
This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes women ages 44 and below scheduled to undergo their first IVF cycle. Subjects are randomized to a CCRI or a control group. The primary outcome measure is dropout rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 44 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •First fresh IVF cycle
- •Using own eggs
- •Able to read, understand, and sign the informed consent in English
- •Must have insurance coverage for IVF cycle
排除标准
- •>1 previous IVF cycle
- •Donor egg cycle
结局指标
主要结局
Drop out rates
时间窗: 12 months
次要结局
未报告次要终点
研究者
Alice D. Domar, PhD
Alice D. Domar, PhD
Boston IVF
