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临床试验/NCT01318291
NCT01318291已完成不适用

An Assessment of the Effect of a Brief Psychological Intervention on Decreasing Drop-Out Rates in IVF Patients

Boston IVF2 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2011年4月最近更新:
适应症

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

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

发起方
Boston IVF
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alice D. Domar, PhD

Alice D. Domar, PhD

Boston IVF

研究点 (2)

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