Does Emotional Support Decrease In Vitro Fertilization Stress?
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
|Official Title:||Does Emotional Support During the Luteal Phase Decrease the Stress of IVF?|
- Perceived Stress Scale Scores [ Time Frame: Day of embryo transfer (day 1) and 10 days later ] [ Designated as safety issue: No ]The perceived stress scale is a validated instrument to assess psychological stress
- Patient perceived benefit [ Time Frame: 10 days after embryo transfer ] [ Designated as safety issue: No ]Exit questionnaires were administered 10 days after transfer to assess patient perceptions of the study.
|Study Start Date:||September 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406028
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|