Pain Clinical Trial
— FAIROfficial title:
Friends/Family in the Abortion Procedure Room (FAIR): Assessing Pain Level, Patient, Staff and Support Person Satisfaction With Support Person in Abortion Procedure Room: A Randomized Controlled Trial
NCT number | NCT03227614 |
Other study ID # | Pro00019968 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 18, 2017 |
Est. completion date | April 5, 2018 |
Verified date | September 2019 |
Source | Planned Parenthood of Southwest and Central Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 422 |
Est. completion date | April 5, 2018 |
Est. primary completion date | April 5, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Patients: - 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 without a support person on-site willing to participate - Patients or support persons that are unable to provide written informed consent in English and comply with all study procedures. |
Country | Name | City | State |
---|---|---|---|
United States | Planned Parentehood of Southwest and Central Florida (PPSWCF) | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Planned Parenthood of Southwest and Central Florida |
United States,
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. — View Citation
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. — View Citation
Kero A, Lalos A, Högberg U, Jacobsson L. The male partner involved in legal abortion. Hum Reprod. 1999 Oct;14(10):2669-75. — View Citation
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. — View Citation
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. — View Citation
Krohne HW, Slangen KE. Influence of social support on adaptation to surgery. Health Psychol. 2005 Jan;24(1):101-5. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety | Evaluating anxiety through State Trait Anxiety Inventory (STAI) | 1 day | |
Secondary | Perceived Pain | Patient Subject will take VAS Pain Scale to evaluate perceived pain | 1 day |
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