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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2019
Source Planned Parenthood of Southwest and Central Florida
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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