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临床试验/NCT01406028
NCT01406028已完成不适用

Does Emotional Support During the Luteal Phase Decrease the Stress of IVF?

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
131
试验地点
1
主要终点
Perceived Stress Scale Scores

研究概览

简要总结

In vitro fertilization for infertility has been associated with a significant amount of treatment related stress for patients. In addition,stress levels increase between embryo transfer and pregnancy test, during this waiting period. The investigators evaluated whether or not brief interventions by phone by trained social workers influenced stress levels. Our data showed that these interventions did not change levels, but confirmed that stress did increase during this time and that patients report wanting additional emotional support to improve stress during this period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •All women (ages 18-45) undergoing their first fresh cycle of IVF using autologous oocytes where an embryo transfer occurred

排除标准

  • •> 2nd cycle of IVF IVF using donor eggs or a gestational carrier
  • •Transfers with Cryopreserved embryos
  • •Day 5 embryo transfers
  • •Self-reported history of depression or anxiety
  • •Already seeing a mental health professional
  • •Inability to speak or read English

研究组 & 干预措施

Standard of Care

No Intervention

Standard of care includes discharge instructions from one of our IVF nurses regarding medications and timing of follow-up, at which point patients are told what day they need to return for their pregnancy test. Patients have access to phone numbers for their IVF nurses and physicians, as well as information about how to contact the social workers if additional support is needed. They also are provided the emergency phone numbers for after-hour calls to the fellow on call. However, during the time between the embryo transfer and the pregnancy test, the current standard of care is that contact between the patient and our team is patient-initiated.

Intervention phone calls

Active Comparator

The intervention consisted of two phone calls from an IVF social worker during the time between embryo transfer and pregnancy test. The first phone call occurred between days 2-4 after transfer and the second phone call occurred between days 5 and 9 after embryo transfer. Standard language for introductions to phone calls and for voice mails was established prior to the start of the study.

干预措施: Phone calls (Behavioral)

结局指标

主要结局

Perceived Stress Scale Scores

时间窗: Day of embryo transfer (day 1) and 10 days later

The perceived stress scale is a validated instrument to assess psychological stress

次要结局

  • Patient perceived benefit(10 days after embryo transfer)

研究者

申办方类型
Other

研究点 (1)

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