Friends/Family in the Abortion Procedure Room (FAIR)

Pain Clinical Trial

— FAIR  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227614
• Other study ID #: Pro00019968
• Status: Completed
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: April 5, 2018

Study information

• Verified date: September 2019
• Source: Planned Parenthood of Southwest and Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Having an abortion is a complexly emotional experience for many women. Women with strong social support, from a partner, friend or family member, report better psychological adjustment. During medication abortion, patients reported high satisfaction levels, in part, because of being able to share the experience with another person. During in-clinic abortion, patients report lower levels of anxiety when they have a support person (partner, spouse, friend or family member) in the post-abortion recovery room. Additionally, support persons indicate feeling they can successfully comfort the woman. In the abortion procedure room, doula support has a positive psychological impact on patients and decreases the need for additional clinic support resources. Because doula support in the abortion procedure room and social support in the post-abortion recovery room improves patient experience, it is reasonable to believe that having a support person in the procedure room may also improve patient experience. However, there are no data about the patient, support person, and health care provider's experience and satisfaction with a support person in the abortion procedure room.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Abortion
• Anxiety
• Pain

Intervention

Behavioral:
• Support Person Intervention
The patient participant will have a support person of her choice accompany her during her abortion procedure.

Locations

Country	Name	City	State
United States	Planned Parentehood of Southwest and Central Florida (PPSWCF)	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Planned Parenthood of Southwest and Central Florida

Country where clinical trial is conducted

United States, 

References & Publications (8)

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

Outcome

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