Friends/Family in the Abortion Procedure Room (FAIR) (FAIR)

September 4, 2019 updated by: Planned Parenthood of Southwest and Central Florida

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

422

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33617
        • Planned Parentehood of Southwest and Central Florida (PPSWCF)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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.
Experimental: Support Person Intervention
This arm of participants will experience the intervention of having a support person of the patient's choice support them during their abortion procedure.
Behavioral: Support Person Intervention
The patient participant will have a support person of her choice accompany her during her abortion procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 1 day
Evaluating anxiety through State Trait Anxiety Inventory (STAI)
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Pain
Time Frame: 1 day
Patient Subject will take VAS Pain Scale to evaluate perceived pain
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Planned Parenthood of Southwest and Central Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2017

Primary Completion (Actual)

April 5, 2018

Study Completion (Actual)

April 5, 2018

Study Registration Dates

First Submitted

July 20, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

September 9, 2019

Last Update Submitted That Met QC Criteria

September 4, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00019968

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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