NCT03227614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2018

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

July 20, 2017

Last Update Submit

September 4, 2019

Conditions

Keywords

abortionsocial supportAnxietyPain

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    Evaluating anxiety through State Trait Anxiety Inventory (STAI)

    1 day

Secondary Outcomes (1)

  • Perceived Pain

    1 day

Study Arms (2)

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.

Behavioral: Support Person Intervention

Interventions

The patient participant will have a support person of her choice accompany her during her abortion procedure.

Support Person Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parentehood of Southwest and Central Florida (PPSWCF)

Tampa, Florida, 33617, United States

Location

Related Publications (8)

  • 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. doi: 10.1037//0022-3514.59.3.452.

    PMID: 2231279BACKGROUND
  • Kero A, Lalos A, Hogberg U, Jacobsson L. The male partner involved in legal abortion. Hum Reprod. 1999 Oct;14(10):2669-75. doi: 10.1093/humrep/14.10.2669.

    PMID: 10528006BACKGROUND
  • 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. doi: 10.1080/01674820400000463.

    PMID: 15715036BACKGROUND
  • 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.

    PMID: 20809674BACKGROUND
  • 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.

    PMID: 21310290BACKGROUND
  • 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.

    PMID: 24983679BACKGROUND
  • Krohne HW, Slangen KE. Influence of social support on adaptation to surgery. Health Psychol. 2005 Jan;24(1):101-5. doi: 10.1037/0278-6133.24.1.101.

    PMID: 15631568BACKGROUND
  • 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. doi: 10.1097/00002508-199812000-00012.

    PMID: 9874014BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 24, 2017

Study Start

July 18, 2017

Primary Completion

April 5, 2018

Study Completion

April 5, 2018

Last Updated

September 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations