Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2021-06-17
2022-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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SPIKES Protocol Compassionate Call
Nurses trained to contact IVF patients with negative pregnancy test results who were trained on the SPIKES-focused bad news delivery script.
Spikes-focused bad news protocol
Nurses trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients.
Control: Standard of Care Call
Nurses who will continue to deliver bad news as they have been in the past without a script.
No interventions assigned to this group
Interventions
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Spikes-focused bad news protocol
Nurses trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients.
Eligibility Criteria
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Inclusion Criteria
* Age \>18
* Underwent an embryo or blastocyst transfer using their own eggs at participating clinic
* Able to read and understand English
* Access to email
* Received a negative pregnancy test result phone call from a nurse involved in the research study
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Weill Medical College of Cornell University
OTHER
Boston IVF
OTHER
Responsible Party
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Alice Domar
Executive Director of Domar Center for Mind Body Health
Principal Investigators
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Alice Domar, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston IVF
Locations
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Boston IVF
Waltham, Massachusetts, United States
Weill Cornell Medical Center Division of Reproductive Medicine
New York, New York, United States
Countries
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References
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Domar AD, Korkidakis A, Bortoletto P, Gulrajani N, Khodakhah D, Rooney KL, Gompers A, Hacker MR, Grill E. The impact of an adapted SPIKES protocol vs routine care in the delivery of bad news to IVF patients: an exploratory pilot multicenter randomized controlled trial. J Assist Reprod Genet. 2024 Sep;41(9):2367-2377. doi: 10.1007/s10815-024-03198-3. Epub 2024 Jul 19.
Other Identifiers
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BN2021
Identifier Type: -
Identifier Source: org_study_id
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