Does Emotional Support Decrease In Vitro Fertilization Stress?
|ClinicalTrials.gov Identifier: NCT01406028|
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : July 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|In Vitro Fertilization Psychological Stress||Behavioral: Phone calls||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Does Emotional Support During the Luteal Phase Decrease the Stress of IVF?|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||June 2010|
No Intervention: Standard of Care
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.
Active Comparator: Intervention phone calls
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.
Behavioral: Phone calls
Phone calls to offer emotional support
- Perceived Stress Scale Scores [ Time Frame: Day of embryo transfer (day 1) and 10 days later ]The perceived stress scale is a validated instrument to assess psychological stress
- Patient perceived benefit [ Time Frame: 10 days after embryo transfer ]Exit questionnaires were administered 10 days after transfer to assess patient perceptions of the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406028
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|