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
422 participants
INTERVENTIONAL
2017-07-18
2018-04-05
Brief Summary
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If this study demonstrates higher patient satisfaction and lower perceptions of pain and anxiety levels in patients who have social support in the in-clinic abortion procedure room, this could change standard procedures in the in-clinic abortion procedure room, allowing for more positive patient experiences.
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Detailed Description
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This study aims to explore patient, support person, and health care providers' experience and satisfaction with social support in the abortion procedure room. Although some providers do allow a support person in the abortion procedure room, no study has formally examined the effects of this practice.
If this study demonstrates higher patient satisfaction and lower perceptions of pain and anxiety levels in patients who have social support in the in-clinic abortion procedure room, this could change standard procedures in the in-clinic abortion procedure room, allowing for more positive patient experiences.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
This arm of participants will not experience the intervention of having a support person of the patient's choice support the patient during their abortion.
No interventions assigned to this group
Support Person Intervention
This arm of participants will experience the intervention of having a support person of the patient's choice support them during their abortion procedure.
Support Person Intervention
The patient participant will have a support person of her choice accompany her during her abortion procedure.
Interventions
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Support Person Intervention
The patient participant will have a support person of her choice accompany her during her abortion procedure.
Eligibility Criteria
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Inclusion Criteria
* Any patient who presents and consents for dilation and curettage
* Patient participants 17 and younger must have a legal guardian provide consent for participation, and the patient must provide assent
* Ability to provide written informed consent in English and comply with all study procedures
Support Persons:
* Any person 18 years and older who the patient selects to accompany as their support person
* Ability to provide written informed consent in English and comply with all study procedures
Health Care Providers:
* Any health center staff attending to the enrolled patient in both intervention and control arms of the study
* Ability to provide written informed consent in English and comply with all study procedures
Exclusion Criteria
* Patients or support persons that are unable to provide written informed consent in English and comply with all study procedures.
ALL
Yes
Sponsors
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Planned Parenthood of Southwest and Central Florida
OTHER
Responsible Party
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Locations
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Planned Parentehood of Southwest and Central Florida (PPSWCF)
Tampa, Florida, United States
Countries
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References
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Major B, Cozzarelli C, Sciacchitano AM, Cooper ML, Testa M, Mueller PM. Perceived social support, self-efficacy, and adjustment to abortion. J Pers Soc Psychol. 1990 Sep;59(3):452-63. doi: 10.1037//0022-3514.59.3.452.
Kero A, Lalos A, Hogberg U, Jacobsson L. The male partner involved in legal abortion. Hum Reprod. 1999 Oct;14(10):2669-75. doi: 10.1093/humrep/14.10.2669.
Kero A, Lalos A. Reactions and reflections in men, 4 and 12 months post-abortion. J Psychosom Obstet Gynaecol. 2004 Jun;25(2):135-43. doi: 10.1080/01674820400000463.
Kero A, Lalos A, Wulff M. Home abortion - experiences of male involvement. Eur J Contracept Reprod Health Care. 2010 Aug;15(4):264-70. doi: 10.3109/13625187.2010.485257.
Veiga MB, Lam M, Gemeinhardt C, Houlihan E, Fitzsimmons BP, Hodgson ZG. Social support in the post-abortion recovery room: evidence from patients, support persons and nurses in a Vancouver clinic. Contraception. 2011 Mar;83(3):268-73. doi: 10.1016/j.contraception.2010.07.019. Epub 2010 Sep 15.
Chor J, Hill B, Martins S, Mistretta S, Patel A, Gilliam M. Doula support during first-trimester surgical abortion: a randomized controlled trial. Am J Obstet Gynecol. 2015 Jan;212(1):45.e1-6. doi: 10.1016/j.ajog.2014.06.052. Epub 2014 Jun 28.
Krohne HW, Slangen KE. Influence of social support on adaptation to surgery. Health Psychol. 2005 Jan;24(1):101-5. doi: 10.1037/0278-6133.24.1.101.
Jensen MP, Miller L, Fisher LD. Assessment of pain during medical procedures: a comparison of three scales. Clin J Pain. 1998 Dec;14(4):343-9. doi: 10.1097/00002508-199812000-00012.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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Pro00019968
Identifier Type: -
Identifier Source: org_study_id
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