Clinical trial NCT03227614: Friends/Family in the Abortion Procedure Room (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Abortion
Keywords: abortion
social support
Anxiety
Pain
Lead sponsor: Planned Parenthood of Southwest and Central Florida
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 422
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety
timeFrame: 1 day
Secondary outcomes:
measure: Perceived Pain
timeFrame: 1 day
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Planned Parentehood of Southwest and Central Florida (PPSWCF)
state: Florida
Study officials:
References:
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