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
Phase: NA
Conditions: Anxiety, Pain, Abortion
Sponsor: Planned Parenthood of Southwest and Central Florida

 
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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 
Principle Investigator: Sujatha Prabhakaran, MD, MPH 
Planned Parenthood of Southwest and Central Florida 
PROJECT SUMMARY 
 
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 [1]. During medication abortion, patients reported high satisfaction levels, in part, 
because of being able to share the experience with another person [2, 3, 4]. 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 [5]. In the abortion procedure room, doula 
support has a positive psychological impact on patients and decreases the need for additional clinic 
support resources [6]. 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. 
1. DESCRIPTION OF THE PROJECT 
1.1 Rationale and objectives of the study 
1.1.1 Rationale 
 
Following elective abortions, patients with strong social support report greater psychological 
adjustment than those without support [1]. In medication abortions, there is a psychological benefit 
to both men and women in being able to support one another and share the abortion process together 
[2].  

 
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The contraceptive partner often has similar motives and feelings as the female partner and is 
interested in being involved in the abortion experience [3, 4]. Following in-clinic abortion, patients 
report lower levels of anxiety when they have a social support person in the post-abortion recovery 
room, and support persons indicate feeling they can successfully comfort the patient [5].  
 
In out-patient surgery procedures, patients with strong social support have less anxiety, take 
lower doses of narcotics, and recover more quickly from operations [7]. Doula support has had a 
similar impact on patient experience in the abortion procedure room, resulting in less need for 
additional clinic support resources. No studies, however, have examined the impact of social 
support on the patient and provider experience in the in-clinic abortion procedure room. Due to the 
significant positive outcomes of having a support person in the post-abortion recovery room, doula 
support in the abortion procedure room and social support in out-patient surgical procedures, a more 
in-depth exploration of the patient, support person, and health care provider’s experience and 
satisfaction with social support in the in-clinic abortion procedure room is advantageous to 
improving the patient’s abortion process. Additionally, some patients have chosen a facility that 
allows a support person in the room over facilities that do not support this practice.    
 
In this study, we propose a randomized, controlled trial permitting a social support person of 
the patient’s choosing to join the patient in the in-clinic abortion procedure room.  
 
1.1.2 Hypotheses and Objectives 
Hypotheses:  
Social support in the abortion procedure room will decrease perceived pain and anxiety levels and 
increase satisfaction for the patient. 
1. Social support in the procedure room influenced the patient’s health outcomes in the 
following areas:  
1. Decreased pain 
2. Decreased anxiety 
3. Increased patient satisfaction  
2.  The social support person will report that they were able to give effective support to the 
patient. 
3. The physician and the nurse will find the support person effective in supporting the patient. 
Null Hypothesis:  
1.   Social support in the abortion procedure room will not change patient levels of perceived 
pain, anxiety, or satisfaction.  
2.   The social support person will report they did not give adequate support.  
3.   The health care provider and the surgical assistant will not find the support person effective 

 
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in supporting the patient.  
 
Objectives 
Primary Aims: 
● To assess a change in expected pain level from baseline, immediately after the procedure, 
and again ten minutes after arrival to the recovery room as determined by a 100mm visual 
analog scale (VAS) for patients with in-room social support during the procedure as 
compared to those who do not. 
● To assess pre- and post-procedure state anxiety levels as determined by the 20-question 
State-Trait Anxiety Inventory (STAI) for patients with in-room social support as compared 
to patients without in-room social support.   
Secondary Aims:  
● To measure acceptability and effectiveness of having social support in the procedure room as 
reported by the surgical assistant and healthcare providers as determined by a post-procedure 
questionnaire.  
● To evaluate if support was effectively given to the patient as reported by the support person 
as determined by a post-procedure questionnaire. 
 
1.2 Previous similar studies 
 
Veiga et al. (2011) evaluated the effects of social support in the post-abortion recovery room 
using a Medical Outcomes Survey (MOS), STAI, and a brief post-procedure questionnaire. The 
study found benefits to having a support person in the recovery room, with a significantly lower 
anxiety levels in accompanied patients. Evaluation of nurses’ perspective on accompaniment found 
that nurses thought the patients may benefit from accompaniment, however, the study also found 
the nurses had concerns related to noise level, patient privacy, and space [5]. Chor et al. (2015) 
examined the effects of doula support in the abortion procedure room. The study found that doula 
support addressed patient psychological needs as those with doula support required less additional 
clinic supportive resources. Despite the positive psychological impact, doula support did not 
significantly affect patient pain or satisfaction [6]. 
 
As these are the only studies examining support in the abortion clinic, the question regarding 
the benefit to patients having social support in the abortion procedure room remains unanswered.  
 
This study will also use the STAI and an adapted post-procedure questionnaire in addition to 
the 100mm VAS.  
 

 
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1.3 Design and methodology 
1.3.1 Research design and General Methodological Approach  
 
This study will be designed as a randomized, controlled trial to compare pain and anxiety 
levels before, during, and after in-clinic abortion in patients with and without a support person in 
the abortion procedure room.  Each procedure day will be randomized into “support person day” 
(“intervention group”) or “non-support person day” (“control group”). This randomization process 
was chosen as the most effective way to randomize without compromising patient care and study 
validity. Limitations to the physical space of the health center prevent patient randomization 
because there is no way to avoid patients knowing which arm of the study they are in: the 
intervention arm or the control arm. 
 
Randomization will occur at the beginning of each procedure day by a research assistant 
who will pull from an opaque envelope that contains ten slips of paper, five will be marked with ‘A’ 
and the other five marked with ‘B’. The half marked ‘A’ will indicate the procedure day will be 
assigned as an “intervention” day, and the other half marked ‘B’ will indicate the day will be 
assigned as a “control” day. After all ten slips of paper are pulled and ten of the procedure days have 
been randomized, the research assistant will replace the ten slips of paper and begin the same 
randomization process until the designated number of participants have been enrolled. The research 
assistant will initiate enrollment of patients in the study after they have consented for the abortion 
procedure. 
 
All patients who present at PPSWCF’s Tampa Health Center for a dilation and curettage 
(D&C), whether for elective pregnancy termination or management of early pregnancy 
complications and who are proficient enough in English to consent and understand the study 
procedures are eligible for participation and enrollment. Support people will be eligible for 
participation and enrollment if they are 18 years of age or older, are privately selected by the patient 
to be their support person, and who are proficient enough in English to consent and understand the 
study procedures. Support people for minors will be privately selected by the patient in conjunction 
with their parent/guardian consent.  
 
1.3.2 Sample Size 
 
A total of 400 subjects will be enrolled in this study; 200 participants will enroll in the 
control arm and 200 will enroll in the intervention arm. Within these two arms, 100 subjects will be 
“patients” and “support persons.” “Patients” are defined as people who will receive an in-clinic 
abortion on the day of their participation. “Support persons” are the individuals whom the patient 
chooses to accompany them during the in-clinic abortion procedure. Support persons will only 
actually accompany patients in the in-clinic procedure room if they are randomized to the 

 
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intervention arm of this study. Health care providers will also be invited to participate in this 
research study—and enrollment numbers will depend upon the amount of unduplicated staff who 
will perform or assist with the D&C procedure on days when enrollment will occur. “Health care 
providers” include the physician performing the abortion and nurses assisting the physician within 
the abortion procedure room. 
Prior studies indicate a 20mm difference in VAS is clinically significant and that the common 
standard deviation for VAS scores is 23 mm [8]. Based on these assumptions, a sample size of 28 with 
14 women in each arm will have 90% power to detect at least a 20mm difference between the change in 
pain score from baseline, to during the procedure, to after the procedure between the two groups, using a 
Student’s t-test evaluated at the 2-sided 0.05 significance level.  
We have chosen a larger sample size to also provide a representative sample of our patient 
population for our secondary aims of patient and support person satisfaction as well as nurse and 
physician satisfaction.  This sample size was calculated based on the total number of in-clinic 
abortion patients seen in the Tampa Health Center in 2015 with a Confidence Level of 95% and a 
Confidence interval of 10.  
 
1.3.4 Criteria for the selection of subjects 
This study will investigate perceptions of pain, anxiety, and satisfaction in patients with a 
support person in the abortion procedure room (“intervention group”). Recruitment will take place 
at PPSWCF’s Tampa Health Center. 
 
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:  

 
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 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. 
 
1.3.5. Criteria for discontinuation 
Participation will be discontinued following an eligibility screening for any of the following 
reasons: 
● Unable to receive an abortion at the health center as determined by the physician 
● Subject no longer wishes to have an in-clinic abortion procedure 
● The support person is perceived by staff as being dangerous or threatening to the safety of 
staff or patients 
● Subject is found to meet exclusion criteria after informed consent has been signed 
● The study is discontinued 
● Subjects chooses to end participation 
 
1.3.6. Subject recruitment 
 
All patients presenting for an in-clinic abortion at the PPSWCF Tampa Health Center will 
be approached by research staff and asked if they are interested in participating in the study after 
they have completed the informed consent for the D&C procedure.  They will be given an 
information sheet describing the study as well as inclusion and exclusion criteria, and will then 
inform research staff if they are interested in participating. If the patient is interested in participating 
in the study, their chosen support person will be given an information sheet describing the study, 
inclusion, and exclusion criteria, and will privately inform research staff if they are interested in 
serving as a support person. If both parties express interest in participating in the study, they will 
undergo the informed consent process together in a private setting.  
 
1.3.7 Admission Procedure 
Enrollment: See section 1.3.6 for details on recruitment.  Enrollment in the study will occur 
in person.   
 
1.3.8 Procedure: 
Eligibility confirmation and consent: 
After the potential patient-subject consents to have a D&C abortion procedure and both the 
patient and support person pass the eligibility screening, the patient and support person will undergo 

 
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the process of informed consent together where both subjects will have an opportunity to ask 
questions. In the cases of minors, a parent/guardian will also be present during this consent process.  
Both subjects will be reminded that participation is voluntary and that if either one decide not to 
participate, their decision will not affect the quality of the patient’s routine care, however neither 
will be eligible to participate, as all subjects must enroll in pairs (support person and patient). The 
research assistant will confirm that participating subjects understand the study and meet the 
inclusion and exclusion criteria. Informed consent for study participation will be signed before any 
study-related procedures are performed and a copy of the consent will be offered to the subject. 
Participation is considered to start when the subject signs the Informed Consent Form. 
Study procedures: 
1.3.8.1 Patient Procedure and Questionnaires 
1) After patients have consented for the D&C procedure and the study, they will complete a 
paper questionnaire. This questionnaire will contain demographic information and type of 
sedation chosen. Additionally, subjects will record their baseline level of expected pain prior 
to the start of the procedure. The subject will also complete the State Trait Anxiety Inventory 
(STAI) after the informed consent process and before the procedure starts.   
2) On randomized intervention days, the patient will be accompanied in the procedure room by 
a support person.  
3) The study physician will enter the room and perform the abortion procedure in the usual 
manner. The abortion procedure will remain the same on intervention days as on control 
days. Immediately after the procedure, the patient will complete the second 100mm VAS. 
Any deviations from this protocol will be recorded. 
4) Once the patient is in the post-abortion recovery room, the patient will complete the STAI 
again, a post-procedure questionnaire, and the final pain level on the 100mm VAS will be 
recorded at least ten minutes after arrival to the recovery room. After all questionnaires have 
been completed and returned to research staff, the subject will be given their reimbursement 
gift card for participation.  
5) The patient’s complete questionnaires will be manually entered in the Qualtrics data 
management software which will only be managed by designated research staff. Study 
documents, including surveys, will be stored in a locked filing cabinet and will be accessed 
by research personnel only. 
 
1.3.8.2 Support Person Questionnaires 
1) After the support person undergoes the informed consent process for the study, they will 
complete a paper questionnaire containing demographic information.  

 
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2) If the support person is in the control arm they will complete and return their paper surveys 
to the research staff before the patient is discharged, and will be given a gift card for their 
participation. 
3) If the support person is in the intervention arm they will then accompany the patient to the 
procedure room and will be given the option of sitting or standing near the head of the 
patient. The support person will return the paper survey to the research staff once completed, 
and will be given a gift card for their participation. 
4) The support person’s complete questionnaires will be manually entered in the Qualtrics data 
management software which will only be managed by designated research staff. Study 
documents, including surveys, will be stored in a locked filing cabinet and will be accessed 
by research personnel only. 
 
1.3.8.3 Health Care Staff Questionnaires 
1) Before the health care staff participates in the study- they will undergo informed consent and 
sign a copy of the informed consent form. Health care staff who choose not to participate 
will be informed that they will not receive any negative consequences for not participating. 
A copy of the informed consent form will be provided to the health care staff. 
2) After each procedure, the physician,  and nurse,  and other health center staff in the abortion 
procedure room caring for the patient will complete a post-procedure questionnaire.  
3) The complete questionnaires will be manually entered in the Qualtrics data management 
software which will only be managed by designated research staff. Study documents, 
including surveys, will be stored in a locked filing cabinet and will be accessed by research 
personnel only. 
 
A sample of the demographic survey, STAI, VAS, and the post-procedure questionnaires for 
the patient, support people, and health care staff is attached at the end of this proposal (see section 
4). 
 
1.3.9 Subject Reimbursement 
 
All participating patients and support people will be eligible to receive a $10 Target gift card 
after completion of study activities. Subjects who receive a gift card will sign a document 
acknowledging receipt of their reimbursement, and gift card logs will be stored in a locked research 
cabinet, as well as within the health center database. Gift card tracking data may be viewed by 
members of PPSWCF’s finance department for tracking and record keeping purposes.  
 
1.3.10. Data management 

 
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The PPSWCF Tampa Health Center research personnel, under the direction of the principal 
investigator, will create and maintain a database on the health center system, as well as in Qualtrics.  
Qualtrics is web-based software for building and managing online surveys and databases, and 
provides the ability for statistical data analysis. Collection of questionnaires and VAS data will be 
done on paper, and will then be directly entered into Qualtrics by research personnel.  Access to this 
database and the paper surveys will be restricted to research staff and study investigators.  Informed 
consent documents, the enrollment log, completed surveys and other study related documents will 
be maintained in a locked filing cabinet. Monitoring of data will be performed by the principal 
investigator and research manager to assure that the research personnel adheres to the protocol, that 
data are entered completely and accurately into the database, that regulatory requirements for 
conducting clinical research are followed, that facilities are adequate to conduct the trial, and that 
IRB approval is obtained. Record storage in Qualtrics is maintained for a maximum of one year.  
Only the research personnel are authorized entry into the research computers in the office. 
Appropriate firewall and virus scanning software are installed and updated routinely by the 
affiliate’s IT department. 
 The Chesapeake IRB will be notified of any serious adverse experiences as per the 
Chesapeake IRB Policy and Procedures Manual Section.  If any severe adverse events or 
complications occur, one of the investigators will notify the IRB within 24 hours and the 
investigators will meet with the Chair of the IRB to assess if the study can continue.   
The principal investigator and the research manager will be responsible for the daily 
monitoring of subject safety, data collection, recruitment, and confidentiality and will therefore 
serve as the foundation of the data and safety monitoring plan.  Enrollment, outcomes, and adverse 
events will be reviewed in weekly meetings.  The research manager will be responsible for 
providing summaries of monitoring reports to the Chesapeake IRB at the time of annual review.   
 
1.3.11 Data Analysis 
Analysis will be performed using Qualtrics statistical software.  Analyses will be performed 
on all control and experimental group data. The control group is defined as the standard care 
without presence of support person, whereas the intervention group is all those receiving standard 
care with the presence of a support person in the procedure room. Demographic, behavioral, and 
clinical characteristics will be compared between the two arms using frequency tests, Student’s t-
test, chi-squared tests, and two-way ANOVA, where appropriate. The change in pain score, as 
assessed by VAS, from baseline to recovery room will be compared within each group using paired 
Student’s t-test if the data are normally distributed or Wilcoxon signed-rank test if the data do not 
follow a Gaussian distribution. Similarly, the difference in the change in VAS scores between the 

 
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study arms will be compared using Student’s t- or Mann-Whitney U tests, where appropriate. 
Questionnaire answers will be compared between both arms of the study using chi-squared 
statistical analysis. Statistical analysis will be performed by both the Principal Investigator and 
statistician. 
 
1.3.12 Study Limitations 
Potential weaknesses in the internal validity of this study are addressed through the study 
design of a randomized controlled trial.  Through randomization, the two study groups should 
theoretically have similar subject characteristics.  One potential weakness is that blinding cannot 
occur.  Also, patients in the control group may be dissatisfied and more anxious at baseline due to 
knowing that they may not have their desired support person in the procedure room.   
One limitation in this study is the potential variation among different providers during in-
clinic abortion; however, all providers will follow the same set standards for the in-clinic abortion 
procedures. This, combined with the fact that there are only a small number of rotating providers 
should decrease this potential limitation. 
 
1.3.13 Duration of project 
Please refer to the attached timeline. 
 
1.4 Project Management 
Sujatha Prabhakaran, MD, MPH is the Principal Investigator for the project. Ashley Sweet, 
MA, is the research manager who will oversee the recruitment and enrollment on this project. Two 
research assistants from PPSWCF will assist in data collection and database maintenance. The 
facilities in this study are staffed by the primary investigator and other PPSWCF physicians. 
PPSWCF has appropriate and secure storage space for research documentation. Study 
documents will be kept at the PPSWCF Tampa Health Center in a locked filing cabinet.  
 
1.5 Links with other projects 
This study is not linked with any other ongoing projects. 
 
1.6 Problems Anticipated  
One of the greatest concerns regarding this study is provider support. Providers at the Tampa 
Health Center will be required to permit support persons in the room.    
Other potential problems include the potential frustration on the part of patients who may 
desire to have support person in the room but are not permitted to do so.    
 

 
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1.7 Expected outcomes of the study and dissemination of findings 
This study aims to evaluate pain and anxiety levels in patients undergoing in-clinic abortion 
as well as assess provider and support person satisfaction when support person is in procedure room 
compared to when support person not in the procedure room.   If this study demonstrates that 
having a support person in the room decreases pain and/or anxiety, this may help to support the 
inclusion of a support person in the procedure room and improve patient experience.  In addition, if 
providers have a good experience, it may help allay provider concerns about having a support 
person in the room.   
The final results will be presented at a national conference and submitted for publication in a 
peer-reviewed journal. 
 
2. ETHICAL CONSIDERATIONS 
This protocol will be submitted to the Chesapeake Institutional Review Board.  The trial will 
also be approved by Planned Parenthood of Southwest and Central Florida (PPSWCF) and Planned 
Parenthood Federation of America’s Clinical Research Department. 
No effective health care will be withheld from study subjects.  In clinical practice, support 
persons are not often allowed in the procedure room.  If a patient states that she would prefer a 
support person in the room, but does not want to participate then she will not be eligible for the 
study and will then be able to have a support person in the procedure room only at the discretion of 
the provider.  
 
2.1 Informed decision-making and confidentiality 
Potential subjects interested in the study will be educated about the risks, benefits, and 
alternatives of study participation. All subjects will be encouraged to ask questions and all questions 
will be answered. The potential subject will be reminded that their participation is voluntary, and 
not participating in the trial will not alter the medical care that the patient will receive. 
 
3. REFERENCES 
[1] Major B, Cozzarelli C, Sciacchitano AM, Cooper ML, Testa M, Mueller PM, Reis HT. 
Perceived social support, self-efficacy, and adjustment to abortion. J Pers Soc Psychol 1990; 59(3): 
452-463. 
 [2] Kero A, Lalos A, Ho ̈gberg U, Jacobsson L. The male partner involved in legal abortion. Hum 
Reprod 1990;14:2669–75.  
[3] Kero A, Lalos A. Reactions and reflections in men 4 and 12 months post-abortion. J Psychosom 
Obstet Gynecol 2004;25:135–43. 

 
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[4] Kero A, Lalos A, Wulff M, Home abortion—experiences of male involvement. Eur J Contracep 
Repr 2010; 15(4): 264-270. 
[5] Veiga MB, Lam M, Gemeinhardt C, Houlihan E, Fitzsimmons BP, Hodgson ZG. Social support 
in post-abortion recovery room: evidence from patients, support persons, and nurses in a Vancouver 
clinic. Contraception 2011; 83(3): 268-273. 
[6] Chor J, Hill B, Martins S, Mistretta S, Patel A, Gillian M. Doula support during first-trimester 
surgical abortion: a randomized controlled tiral. Am J Obstet Gynecol 2015; 212(1): 45.e-16. 
[7] Krohne HW, Slagen KE. Influence of social support on adaptation to surgery. Health 
Psychology 2005; 24(1): 101-105. 
[8] Jensen MP, Miller L, Fisher LD. Assessment of pain during medical procedures: a comparison 
of three scales. Clin J Pain.1998; 14(4): 343-9. 
 
 
 

 
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4. RESEARCH INSTRUMENTS/QUESTIONNAIRES 
4.1 SUBJECT DEMOGRAPHIC QUESTIONNAIRE – INTERVENTION ARM 
Please fill in the information below, if applicable: 
 
Age: ________________ 
 
 
Gestational age (How many weeks pregnant are you?) ________________ 
 
Number of children: ________________ 
 
Number of previous abortions: ________________ 
Religion: ___________________________________             
Please circle your answers below: 
Ethnicity:  
Hispanic 
Non-Hispanic 
 
Race:   
American Indian or Alaska Native 
 
 
Asian 
 
 
Black or African American 
 
 
Native Hawaiian or other Pacific Islander 
 
 
White 
 
 
Two or more races 
 
Marital Status:  
Single   
Married  
Divorced  
Widowed  
Separated  
 
Are you using your insurance for the procedure?  
 
Yes 
 
No 
 
Are you receiving sedation for the procedure? 
 
Yes 
 
No 
 
What is your relation to the patient/support person? ______________________________ 

 
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4.1 SUBJECT DEMOGRAPHIC QUESTIONNAIRE – CONTROL ARM 
Please fill in the information below, if applicable: 
 
Age: ________________ 
 
 
Gestational age (How many weeks pregnant are you?) ________________ 
 
Number of children: ________________ 
 
Number of previous abortions: ________________ 
Religion: ___________________________________             
Please circle your answers below: 
Ethnicity:  
Hispanic 
Non-Hispanic 
 
Race:   
American Indian or Alaska Native 
 
 
Asian 
 
 
Black or African American 
 
 
Native Hawaiian or other Pacific Islander 
 
 
White 
 
 
Two or more races 
 
Marital Status:  
Single   
Married  
Divorced  
Widowed  
Separated  
 
Are you using your insurance for the procedure?  
 
Yes 
 
No 
 
Are you receiving sedation for the procedure? 
 
Yes 
 
No 
 
What is your relation to the patient/support person? ______________________________ 
 

 
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4.2 POST-PROCEDURE QUESTIONNAIRE FOR PATIENT - INTERVENTION ARM 
Please circle your answers below: 
      
1. I would rate my overall satisfaction with the procedure as: 
 Very satisfied 
 Somewhat satisfied 
 Neutral 
 Somewhat dissatisfied  
 Very dissatisfied  
2. The amount of discomfort I experienced during the procedure was acceptable.  
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
 
3. I feel that the amount of support I received from my support person in the procedure room 
helped decrease my pain.  
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
 
4. I feel that I received all the support I needed from my support person in the procedure room. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 

 
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5. The presence of my support person in the procedure room made me feel uncomfortable. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
 
6. If you were uncomfortable in the procedure room, were you uncomfortable due to any of the 
following: (Circle all applicable options) 
- 
Facility (ex. too cold, too small, uncomfortable chair, etc) 
- 
Staff (instructions, attentiveness, respect, etc.) 
- 
Beliefs (religious ideology, aversion to medical procedures, etc.)  
- 
Other:___________________________  
- 
Not applicable 
Please provide any additional information: 
________________________________________________________________________________
________________________________________________________________________________
__________________________________________________________________________ 
 
7. During my procedure with my support person in the room, I felt concerned about the following: 
(Please circle all that apply) 
Privacy 
Security 
Other: ________________________________________________________________ 
Not applicable 
 
 
 

 
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8. If I had to re-live this experience, I would prefer/choose to be accompanied in the procedure 
room again.  
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
 
9. Do you have any additional comments or concerns about having a support person in the 
procedure room? 
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________ 
 
Thank You!

 
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4.3 POST-PROCEDURE QUESTIONNAIRE FOR PATIENT - CONTROL ARM 
Please circle your answers below: 
      
1. I would rate my overall satisfaction with the procedure as: 
 Very satisfied 
 Somewhat satisfied 
 Neutral 
 Somewhat dissatisfied  
 Very dissatisfied  
2. The amount of discomfort I experienced during the procedure was acceptable.  
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
3. I believe that having a support person in the procedure room would have helped decrease my 
pain.  
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
4. If I had to re-live this experience, I would prefer/choose to be accompanied in the procedure 
room. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
  

 
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5. Do you have any additional comments or concerns about having a support person in the 
procedure room? 
 
 
 
 
 
 
 
 
Thank You! 
 

 
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4.4 VISUAL ANALOG SCALE (VAS) 
For these questions we are going to ask you to make an X on a line. For example, let's say you are 
asked how much you like Oreo cookies: 
 
How much do you like Oreo cookies? (Make an X on the line) 
 
very       
 
 
 
 
 
 
 
very 
 
 
little  
 
 
 
 
 
 
 
much 
 
Answer the question by making an "X" on the line according to how much you like or dislike Oreo 
cookies. If you liked Oreo cookies a lot, then you might make an "X" on the line like so:  
 
 
very       
 
 
 
 
 
 
 
very 
 
 
little  
 
 
 
 
 
 
 
much 
 
If you liked Oreo cookies more than life itself(!), then you might make an "X" on the line like so: 
 
 
very       
 
 
 
 
 
 
 
very 
 
 
little  
 
 
 
 
 
 
 
much 
 
If you hated Oreo cookies, then you might make an "X" like so: 
 
 
very       
 
 
 
 
 
 
 
very 
 
 
little  
 
 
 
 
 
 
 
much 
 
If you thought Oreo cookies were just "OK," then you might make an "X" like so: 
 
 
very       
 
 
 
 
 
 
 
very 
 
 
little  
 
 
 
 
 
 
 
much 
 
The idea is that if you like Oreo cookies, you make an "X" on the line closer to the phrase "very 
much." The closer you make the "X," the more you are saying you like Oreo cookies.  If you don't 
like Oreo cookies, you make an "X" on the line closer to the phrase "very little." The closer you make 
the "X," the more you are saying you don't like Oreo cookies. 
 
 
 

 
Last updated: 4/10/2017 
21 
Please mark an X on the line to indicate your response to the following questions. 
1. How much pain do you think you will have during procedure? 
 
no 
worst pain 
 
pain 
 
in my life 
 
ACTUAL TIME OF ASSESSMENT __ __:__ __ 
2. How much pain you are having now (immediately at the end of the abortion 
procedure)?  
 
no 
worst pain 
 
pain 
 
in my life 
 
ACTUAL TIME OF ASSESSMENT __ __:__ __ 
3. How much pain you are having now (in the post-abortion recovery room)? 
 
no 
worst pain 
 
pain 
in my life 
 
ACTUAL TIME OF ASSESSMENT __ __:__ __ 
 
 
 
 
 

 
Last updated: 4/10/2017 
22 
4.5 POST-PROCEDURE QUESTIONNAIRE FOR SUPPORT PERSON- INTERVENTION 
Please circle your answers below: 
1) I had a clear understanding of my role as a support person during the procedure. 
 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
2) I feel I provided effective support to the patient in the procedure room. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
3) I feel that the patient was comforted by my presence in the room.  
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not  
4) I was comfortable in the procedure room. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
Don’t know/no opinion 

 
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23 
5) If you felt uncomfortable in the procedure room, were you uncomfortable due to any of the 
following: (circle all that apply) 
- Facility (ex. too cold, too small, uncomfortable chair, etc) 
- Staff (ex. instructions, attentiveness, respect, etc.) 
- Beliefs (ex. religious ideology, aversion to medical procedures, etc.) 
- Other:___________________________  
- Not applicable 
Please provide additional information: 
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________ 
6) Based on my experience today, I would serve as a support person during an abortion procedure 
again.  
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
Don’t know/no opinion 
10) Do you have any additional comments or concerns about being a support person in the 
procedure room?  
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________ 
 
Thank You!  
 

 
Last updated: 4/10/2017 
24 
4.6 POST-PROCEDURE QUESTIONNAIRE FOR SUPPORT PERSON- CONTROL 
Please circle your answers below: 
 
1. I had a clear understanding of what my role as a support person would have been during the 
procedure. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
2. I feel I would have provided effective support to the patient in the procedure room. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
3. I feel that the patient would have been comforted by my presence in the room.  
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not  
 
 
 
 
 

 
Last updated: 4/10/2017 
25 
4. I believe I would be comfortable being in the procedure room during the in-clinic abortion 
procedure. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
Don’t know/no opinion 
  
5. Do you have any additional comments or concerns about being a support person in the procedure 
room? 
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________ 
 
Thank You!  
 
 

 
Last updated: 4/10/2017 
26 
4.7 POST-PROCEDURE QUESTIONNAIRE FOR HEALTH CARE STAFF  - 
INTERVENTION ARM  
Please circle your answers below: 
1. The presence of the support person in the procedure room was helpful to me. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
2. The presence of a support person in the procedure room was helpful to the patient.  
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
3. I felt uncomfortable with the support person’s presence in the procedure room. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
4. During the patient’s procedure, I felt concerned about the following due to the support person’s 
presence: (Please circle all that apply)  
Privacy; please specify _______________________________ 
Security; please specify _______________________________ 
Other ________________________ 
Not applicable  

 
Last updated: 4/10/2017 
27 
 
Please provide additional information: 
_____________________________________________________________________________
_____________________________________________________________________________
_______________________________________________________________________ 
5)  I felt that I had to provide support to the support person in the procedure room.  
 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
6)  I would like the accompaniment in the procedure room to become a permanent arrangement. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
Don’t know/no opinion 
7) MVA: 
 
 
YES  
or  
NO 
 
8) Complications: 
 
 
YES  
or  
NO 
 
9) Do you have any additional comments or concerns about having a support person in the 
procedure room?  
 
 
Thank You! 

 
Last updated: 4/10/2017 
28 
4.8 POST-PROCEDURE QUESTIONNAIRE FOR HEALTH CARE STAFF - CONTROL 
ARM  
Please circle your answers below: 
1. The presence of the support person in the procedure room would have been helpful to me. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
2. The presence of a support person in the procedure room would have been helpful to the patient.  
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
3. I would have felt uncomfortable with the support person’s presence in the procedure room. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
4. During the patient’s procedure, I believe I would have concerns in the following areas if the 
support person was present: (Please circle all that apply)  
Privacy; please specify _______________________________ 
Security; please specify _______________________________ 
Other ________________________ 
Not applicable  
Please provide additional information: 

 
Last updated: 4/10/2017 
29 
______________________________________________________________________________
______________________________________________________________________________
_____________________________________________________________________ 
5. If the patient was accompanied by a support person, I feel like I would have had to provide 
additional support for the support person.  
 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
6. I would like the accompaniment in the procedure room to become a permanent arrangement. 
Definitely yes 
Probably yes 
Neutral 
Probably not 
Definitely not 
7. MVA: 
 
 
YES  or  
NO 
 
8. Complications: 
 
 
YES  or  
NO 
 
9. Do you have any additional comments or concerns about having a support person in the 
procedure room?      
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________ 
 
Thank You! 

 
Last updated: 4/10/2017 
30 
5. PROJECT TIMELINE 
Project Title: Assessing pain level, patient and staff satisfaction with support person in 
abortion procedure room: A randomized controlled trial 
 
 
 
 
Time Period: October 2014 – January 2018 
 
 
Year 1 &2 
Oct 
- 14 
Nov 
- 14 
Dec 
- 14 
May - 
16 
Jun-
16 
Jul- 
16 
Au
g - 
16 
Sept- 
16 
Oct - 
16 
Nov -16 
 
Protocol 
development 
x 
  
  
 x 
 x 
x 
 x 
     x 
    x 
    x 
 
Consent material 
development 
 
x 
x  
x  
x  
x 
 x 
  
  
  
 
Year 3 
Feb 
17 
May 
-17 
Jun 
-17 
Jul -17 
Aug
- 17 
Sep
-17 
Oct
-17 
Nov-
17 
Dec-
17 
Jan-18 
 
IRB Submission 
x 
 
 
 
 
 
 
 
 
 
 
Staff training 
 
x 
x 
 
 
 
 
 
 
 
Database 
Development 
 
x 
x 
 
 
 
 
 
 
 
Subject recruitment 
& Enrollment 
 
 
 
x 
x 
x 
 
 
 
 
Data collection 
  
 
 
x 
 x 
x 
 
 
 
 
Data analysis 
  
 
 
 
  
x 
x 
 
 
 
Final report and 
manuscript writing 
  
  
  
 
 
 
 
x 
x 
x