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Clinical Trials/NCT03227614
NCT03227614CompletedNot Applicable

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

Planned Parenthood of Southwest and Central Florida2 sites in 1 country422 target enrollmentStarted: July 18, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
422
Locations
2
Primary Endpoint
Anxiety

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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 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.

Arms & Interventions

Control

No Intervention

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.

Support Person Intervention

Experimental

This arm of participants will experience the intervention of having a support person of the patient's choice support them during their abortion procedure.

Intervention: Support Person Intervention (Behavioral)

Outcomes

Primary Outcomes

Anxiety

Time Frame: 1 day

Evaluating anxiety through State Trait Anxiety Inventory (STAI)

Secondary Outcomes

  • Perceived Pain(1 day)

Investigators

Sponsor
Planned Parenthood of Southwest and Central Florida
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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