<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227614</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00019968</org_study_id>
    <nct_id>NCT03227614</nct_id>
  </id_info>
  <brief_title>Friends/Family in the Abortion Procedure Room (FAIR)</brief_title>
  <acronym>FAIR</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Planned Parenthood of Southwest and Central Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Planned Parenthood of Southwest and Central Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to explore patient, support person, and health care providers' experience and&#xD;
      satisfaction with social support in the abortion procedure room. Although some providers do&#xD;
      allow a support person in the abortion procedure room, no study has formally examined the&#xD;
      effects of this practice.&#xD;
&#xD;
      If this study demonstrates higher patient satisfaction and lower perceptions of pain and&#xD;
      anxiety levels in patients who have social support in the in-clinic abortion procedure room,&#xD;
      this could change standard procedures in the in-clinic abortion procedure room, allowing for&#xD;
      more positive patient experiences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Having an abortion is a complexly emotional experience for many women. Women with strong&#xD;
      social support, from a partner, friend or family member, report better psychological&#xD;
      adjustment. During medication abortion, patients reported high satisfaction levels, in part,&#xD;
      because of being able to share the experience with another person. During in-clinic abortion,&#xD;
      patients report lower levels of anxiety when they have a support person (partner, spouse,&#xD;
      friend or family member) in the post-abortion recovery room. Additionally, support persons&#xD;
      indicate feeling they can successfully comfort the woman. In the abortion procedure room,&#xD;
      doula support has a positive psychological impact on patients and decreases the need for&#xD;
      additional clinic support resources. Because doula support in the abortion procedure room and&#xD;
      social support in the post-abortion recovery room improves patient experience, it is&#xD;
      reasonable to believe that having a support person in the procedure room may also improve&#xD;
      patient experience. However, there are no data about the patient, support person, and health&#xD;
      care provider's experience and satisfaction with a support person in the abortion procedure&#xD;
      room.&#xD;
&#xD;
      This study aims to explore patient, support person, and health care providers' experience and&#xD;
      satisfaction with social support in the abortion procedure room. Although some providers do&#xD;
      allow a support person in the abortion procedure room, no study has formally examined the&#xD;
      effects of this practice.&#xD;
&#xD;
      If this study demonstrates higher patient satisfaction and lower perceptions of pain and&#xD;
      anxiety levels in patients who have social support in the in-clinic abortion procedure room,&#xD;
      this could change standard procedures in the in-clinic abortion procedure room, allowing for&#xD;
      more positive patient experiences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2017</start_date>
  <completion_date type="Actual">April 5, 2018</completion_date>
  <primary_completion_date type="Actual">April 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluating anxiety through State Trait Anxiety Inventory (STAI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived Pain</measure>
    <time_frame>1 day</time_frame>
    <description>Patient Subject will take VAS Pain Scale to evaluate perceived pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">422</enrollment>
  <condition>Anxiety</condition>
  <condition>Pain</condition>
  <condition>Abortion</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Support Person Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of participants will experience the intervention of having a support person of the patient's choice support them during their abortion procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Support Person Intervention</intervention_name>
    <description>The patient participant will have a support person of her choice accompany her during her abortion procedure.</description>
    <arm_group_label>Support Person Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  Any patient who presents and consents for dilation and curettage&#xD;
&#xD;
          -  Patient participants 17 and younger must have a legal guardian provide consent for&#xD;
             participation, and the patient must provide assent&#xD;
&#xD;
          -  Ability to provide written informed consent in English and comply with all study&#xD;
             procedures&#xD;
&#xD;
        Support Persons:&#xD;
&#xD;
          -  Any person 18 years and older who the patient selects to accompany as their support&#xD;
             person&#xD;
&#xD;
          -  Ability to provide written informed consent in English and comply with all study&#xD;
             procedures&#xD;
&#xD;
        Health Care Providers:&#xD;
&#xD;
          -  Any health center staff attending to the enrolled patient in both intervention and&#xD;
             control arms of the study&#xD;
&#xD;
          -  Ability to provide written informed consent in English and comply with all study&#xD;
             procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without a support person on-site willing to participate&#xD;
&#xD;
          -  Patients or support persons that are unable to provide written informed consent in&#xD;
             English and comply with all study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Planned Parentehood of Southwest and Central Florida (PPSWCF)</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>2231279</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10528006</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15715036</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20809674</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21310290</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24983679</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15631568</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9874014</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>September 4, 2019</last_update_submitted>
  <last_update_submitted_qc>September 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>abortion</keyword>
  <keyword>social support</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Pain</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03227614/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03227614/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227614
org study id: Pro00019968
nct id: NCT03227614
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Anxiety
time frame: 1 day
description: Evaluating anxiety through State Trait Anxiety Inventory (STAI)
measure: Perceived Pain
time frame: 1 day
description: Patient Subject will take VAS Pain Scale to evaluate perceived pain
arm group label: Control
arm group type: No Intervention
description: 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.
arm group label: Support Person Intervention
arm group type: Experimental
description: 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 type: Behavioral
intervention name: Support Person Intervention
description: The patient participant will have a support person of her choice accompany her during her abortion procedure.
arm group label: Support Person Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: 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: 2231279
citation: 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: 10528006
citation: 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: 15715036
citation: 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: 20809674
citation: 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: 21310290
citation: 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: 24983679
citation: 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: 15631568
citation: 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: 9874014
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 