Patient Support During Surgical Abortion

Study Overview
=================
Brief Summary
-----------------
This study will be a non-blinded randomized controlled trial (RCT) of women presenting for abortion at <13 6/7 weeks. Women will be randomized either to receive support by a trained abortion doula (intervention) or to have standard procedure (control) during the abortion procedure. The investigators hypothesize that women who receive doula support during a first trimester abortion will report less pain during the abortion procedure compared to women who do not receive abortion doula support.

Official Title
-----------------
Patient Support During Surgical Abortion

Conditions
-----------------
Surgical Abortion

Intervention / Treatment
-----------------
* Other: Doula Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged > 18 years Gestational age by sonogram < 13 6/7 weeks gestation Desires pregnancy termination Ability to understand the study and give informed consent Ability to read and comprehend informed consent document in English Exclusion Criteria: Aged < 18 years Gestational age by sonogram > 13 6/7 weeks gestation Inability to understand the study and give informed consent Inability to read and comprehend informed consent document in English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doula Arm<br>Women in the doula arm will have standard procedure protocol with addition of doula support at the time of the procedure. | Other: Doula Arm<br> <br> |
| No Intervention: Control Group<br>Women in the control arm will have standard procedure protocol at the time of the procedure. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at time of procedure | To determine the effect of abortion doula support during a 1st trimester abortion (< 13 6/7 wks gestational age) on the pain at the time of the abortion, as measured using a 100-mm Visual Analog Scale (VAS). | At time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with procedure | To assess the impact of abortion doula support on a woman's overall satisfaction with the abortion experience, as measured using a 100-mm Visual Analog Scale (VAS) | 10 minutes post-procedure | 
| Difficulty of procedure | To assess the impact of abortion doula support on the provider's assessment of difficulty of procedure, as measured using a 4-point Likert scale. | Immediately post-procedure | 
| Duration of procedure | To assess the impact of doula support on the duration of the procedure, from placement of the speculum to removal of the speculum upon completion of the procedure. | During procedure | 
| Pain at time of speculum insertion | To determine the effect of abortion doula support during a 1st trimester abortion on the pain at the time of speculum insertion, as measured using a 100-mm Visual Analog Scale (VAS). | At time of speculum insertion | 
| Anticipated pain | To assess pain anticipated prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS). | Prior to procedure | 
| Pre-procedure anxiety | To assess anxiety prior to procedure, as measured using a 100-mm Visual Analog Scale (VAS). | Prior to procedure | 
| Post-procedure recalled pain | To assess recalled pain 10 minutes post-procedure, as measured using a 100-mm Visual Analog Scale (VAS). | Post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Doula, Abortion, Pain, support