Although intrauterine devices (IUDs) have been available in the United States for decades, utilization rates remain low among adolescent and young adult women.1 Only 4% use IUDs compared with 12% of women older than age 20 years.2–4 The contraceptives most commonly used by young women (pills, patch, and ring) are 20 times less effective than IUDs.5,6 Given the high rate of unintended pregnancies in this population, improving IUD use is important.5,6 Barriers to IUD utilization include lack of knowledge, negative personal attitudes, negative social norms, and limited IUD access, particularly in pediatric care settings.7–9 Interventions have focused on improving access, promoting patient-centered counseling, and endorsing long-acting methods.10,11
An understudied aspect of IUD utilization is women's perceptions of the insertion procedure. For young women, concern about discomfort during placement is a major barrier to IUD use. Improving our understanding of young women's experiences during the procedure may aid with counseling and service delivery, help address preprocedure anxiety, identify modifiable aspects of the procedure, and improve IUD uptake.7–9,12 Existing studies assess young women's satisfaction with the IUD measure 6–12 months after device placement; we are not aware of any studies among young women that assess this construct immediately after IUD insertion.13–15 In the current study, we examine satisfaction with the IUD insertion procedure and among adolescent and young adult women participating in a randomized clinical trial that examined the effectiveness of a 1% lidocaine paracervical nerve block on pain reported during IUD insertion compared with a sham block.
MATERIALS AND METHODS
This was a secondary analysis of data from a multisite, single-blind, sham-controlled randomized trial to examine differences in pain scored using a visual analog scale during IUD insertion. The study was conducted at three clinics in Philadelphia, Pennsylvania, from March 2015 to July 2016 that involved one study visit. The sample size of 43 participants per treatment group was estimated to address the primary outcome of pain during IUD insertion using a two-sided test, assumed a SD of 28 mm, a 20-mm difference in visual analog scale scores, an α of 0.05, and 90% power.16,17 The Consolidated Standards of Reporting Trials guidelines were followed to design and report the trial; full details regarding the trial are reported elsewhere.18 The protocol is available by request. Institutional review board approval was obtained from the Children's Hospital of Philadelphia (which was the institutional review board of record), Hospital of the University of Pennsylvania, and Thomas Jefferson University, all of which performed study visits. Approval was also obtained from AccessMatters, which funds Title X clinics in southeastern Pennsylvania, which allowed study recruitment flyers to be posted in Title X clinics that refer adolescents to Children's Hospital of Philadelphia for IUD insertions. The trial was registered with Clinicaltrials.gov (NCT# NCT02352714).
Women presenting to a study site requesting a hormonal IUD were asked by a clinician whether they were interested in talking with research staff about the study. Interested women seeking reproductive health services at a nonenrolling study site who saw a recruitment flyer called the study coordinator who described the study and scheduled a study visit. Patients were eligible for inclusion if they were between ages 14 and 22 years, nulliparous, not pregnant currently, not pregnant in the prior 6 weeks, interested in the Skyla IUD (13.5-mg levonorgestrel IUD), and English-speaking. The cutoff of 22 years, rather than 24 years, was chosen to minimize the number of older, young adult women. Patients were excluded if they did not meet medical eligibility criteria for an IUD19; had a contraindication to taking amino amide anesthetics or nonsteroidal antiinflammatory agents; were unwilling to be randomized; were at high risk for pregnancy; used narcotics or benzodiazepine in the prior 24 hours; previously used an IUD; or had a prior unsuccessful IUD insertion. Women could enroll at a later date if inclusion criteria were not initially met. Written informed consent was obtained from all participants, regardless of age, because females 13 years of age and older in Pennsylvania can legally consent for reproductive services and research studies regarding reproductive services and because requiring parental permission for study participation would have compromised confidentiality.
Participants completed a questionnaire assessing demographic characteristics and their medical and reproductive history. Before randomization, participants received 800 mg ibuprofen orally at least 20 minutes before the procedure to reduce postprocedure pain.20 Randomization was performed by a research coordinator in the Research Data Capture software in block sizes of four with stratification by age (14–17 or 18–22 years), race, and recruitment site after completion of the demographic questionnaire. Only patients were blinded to group assignment. The lidocaine block group received 1 mL of 1% lidocaine at the tenaculum site and 4.5 mL at 4 o'clock and 8 o'clock at the cervicovaginal junction. For the sham block, pressure was applied to these same three sites with the unbroken, wood end of a cotton-tipped applicator to depress the vaginal epithelium 1 mm. There was a 3-minute delay after administering the lidocaine and sham block before IUD insertion to allow onset of action for the lidocaine. Intrauterine device insertion followed the manufacturer's instructions, including sounding the uterus before inserting the IUD. All devices were inserted by an experienced health care provider who was an attending physician or a family planning fellow.
After IUD insertion, clinicians completed a questionnaire assessing procedural details (uterine size and depth, need for dilation or ultrasound guidance, and adverse events). One item assessed health care provider-rated patient anxiety by asking whether the patient's general affect seemed “pleasant and appropriately engaging” or “anxious.” After IUD insertion, a postprocedure questionnaire was administered to participants by a research coordinator to rate their satisfaction with and discomfort during the procedure.
Participants who completed all study activities received $50 for their time. Devices were provided free of charge by the study funder. Participants' insurance was billed for the clinical procedure fee. Clinicians were not compensated for performing the IUD insertion nor for completing the questionnaire.
Satisfaction with the IUD insertion procedure was measured using three single-item satisfaction measures adapted from items commonly used to assess satisfaction with various dimensions of clinical care. Overall satisfaction was assessed with an item that asked, “How would you rate your overall satisfaction with your IUD placement?” Response options ranged from “very dissatisfied” (1) to “very satisfied” (5). Participants were classified as satisfied if they responded “very satisfied.” The second item asked whether participants would “recommend an IUD to a friend.” Response options included, “definitely yes,” “probably yes,” “neutral,” “probably not,” “definitely not,” and “don't know, no opinion.” Participants were classified as satisfied if they responded “definitely yes.” The third item asked whether getting the IUD “was worth the discomfort.” Response options were “yes,” “no” or “unsure.” Higher scores denoted greater satisfaction, higher IUD recommendation, or the belief that the procedure was worthwhile, respectively.
Demographic variables included age, race, Hispanic ethnicity, marital status, insurance status, and education level. Sexual and reproductive history variables included age at menarche and whether participants had ever been sexually active, pregnant, used hormonal birth control, had a gynecologic examination, or were currently using birth control. As part of the medical history, participants completed the four-item Patient Health Questionnaire-4, which consists of a two-item depression scale and a two-item anxiety scale. Scores greater than 3 suggest clinical depression or anxiety, respectively.21 The single-item health care provider-rated anxiety variable was dichotomous (yes or no). Pain at IUD insertion was recorded using a 100-mm visual analog scale. Participants touched a line anchored from “no pain” (0 mm) to “worst pain in my life” (100 mm) using an iPad at seven time points: baseline (before placement in lithotomy), immediately after speculum placement, tenaculum placement, block administration, uterine sounding, IUD insertion, and 5 minutes after speculum removal. The pain score reported immediately after IUD insertion, which was the primary outcome for the parent study, was included in the models. Treatment group assignment (paracervical block compared with sham block group) was also included. Between-group differences in the baseline characteristics for the treatment groups were compared using χ2 test for proportions, Fisher exact test for small numbers, and Wilcoxon rank-sum tests for continuous data that were not normally distributed.
Each of the three outcome variables were ordinal and highly skewed, with more than two thirds of participants selecting the highest response category reflecting high overall satisfaction with the procedure, high likelihood of recommending an IUD to a friend, and a strong belief that the IUD was worth the discomfort. All three outcomes were therefore dichotomized to compare the highest response category with all the other response categories combined. Separate logistic regression models were run for each of the three dependent variables.
Predictor variables with small sample sizes (less than 10% of respondents per cell) were excluded from analysis (ie, Hispanic ethnicity, marital status, ever sexually active, prior pregnancy, self-reported depression and anxiety, and health care provider rating of participant's anxiety). The variable assessing whether participants had “ever used birth control” was excluded because it was highly correlated with the variable assessing “current birth control use,” which was included. Age was dichotomized to assess whether younger age (14–17 years) or older age (18–22 years) was a significant predictor of each outcome. Race was dichotomized as white compared with nonwhite. Education level was continuous with higher levels reflecting more education. Number of prior gynecologic examinations and pain scores after IUD insertion were used as predictors of each outcome as well. Odds ratios (ORs) and 95% CI estimates in the multivariable models were robust to the number of predictors selected. Two-tailed P values <.05 were considered significant. Analyses were completed with SAS 9.3.
Of the 95 participants who enrolled in the trial, 93 were included in the outcome analysis. One was dropped as a result of missing insurance data and the other as a result of missing pain score at IUD insertion. Participant characteristics are shown in Table 1. The mean age of the sample was 19.4±2.1 years. Almost half (45) were white (47.4%) and one third were black (36.0%). Most were ages 18–22 years (80.0%), never married (95.8%), had at least some college education (67.4%), and were privately insured (66.0%). Most also reported having had sex at least once (91.6%) and prior contraceptive use (79.0%); few reported current contraceptive use (43.2%) or a prior pregnancy (4.2%). Two thirds (69.5%) reported having a prior gynecologic examination; the types of gynecologic examinations varied with 59.0% reporting a prior visual inspection of the vulva, 51.6% reported a prior bimanual examination, 44.2% reported a prior speculum examination, and 30.5% reported a prior Pap test.
Participants were equally distributed among the treatment groups with 47 randomized to the paracervical block group and 48 to the sham group (Fig. 1). The baseline characteristics were similar in both groups, except those in the paracervical block group were less likely to be current contraceptive users compared with those in the sham group (31.9% vs 54.2%, P=.03). The median pain score (±interquartile range) reported immediately after IUD insertion for the sample was 63.5±53 with lower scores in the lidocaine paracervical block group compared with the sham block group (30.0±52 vs 71.5±23.5, P<.001).
Most participants reported being “very satisfied” with their IUD insertion procedure (n=73 [76.8%]) with 14 (14.7%) being “somewhat satisfied,” six (6.3%) were “neutral,” one (1.1%) was “somewhat dissatisfied,” and one (1.1%) was very dissatisfied. There were no differences in satisfaction between the lidocaine block group compared with the sham group (91.5% vs 91.7%, P=.30).
As shown in Table 2, the odds of reporting higher overall satisfaction were lower among younger adolescents compared with older adolescents (OR 0.07, 95% CI 0.008–0.68) and among those who had never had a gynecologic examination compared with those who had (OR 0.26, 95% CI 0.069–0.99), and they decreased as the pain score after IUD insertion increased (OR 0.96, 95% CI 0.94–0.99). When asked whether they would recommend an IUD to a friend, 64 (67.4%) said “definitely yes,” 20 (21.1%) “probably yes,” six (6.3%) were neutral, three (3.2%) “probably no,” and two (2.1%) “definitely no.” There were no differences in recommending an IUD insertion to a friend among the lidocaine block group compared with the sham group, (91.5% vs 85.4%, P=.45). As shown in Table 2, the odds of recommending an IUD to a friend decreased as the pain score after IUD insertion increased (OR 0.96, 95% CI 0.941–0.986). Odds of recommending an IUD to a friend were lower among those who had never had a gynecologic examination compared with those who had, but this did not reach statistical significance (OR 0.32, 95% CI 0.10–1.01).
Most participants endorsed that getting the IUD was “worth the level of discomfort” (n=79 [83.2%]), none reported that it was “not worth the level of discomfort,” and 16 (16.8%) were “unsure at this time.” There were no differences between the lidocaine block group compared with the sham group (44.2% vs 39.0%, P=.11). As shown in Table 2, the odds of reporting that getting the IUD was worth the discomfort decreased as the pain score after IUD insertion increased (OR 0.96, 95% CI 0.93–0.99).
Utilization of IUDs is low among adolescents and young adult women, in part as a result of fears regarding discomfort during the insertion process.7,8,12 In this secondary data analysis study, we examined three dimensions of satisfaction with the IUD insertion procedure among adolescent and young adult women. We found that the majority of young women reported high satisfaction with the IUD insertion procedure. Eight of 10 women reported high overall satisfaction with the procedure and believed the procedure was worth the discomfort they experienced. Seven of 10 would recommend an IUD to a friend. Higher pain during IUD insertion was the only variable associated with lower odds of satisfaction with the procedure on all three satisfaction measures.
Patient satisfaction is an important aspect of evaluating the quality of health care services,16,22 with pain management increasingly recognized as being highly correlated with satisfaction.22 Few studies have examined associations between pain management and patient satisfaction with procedures performed in outpatient clinic settings. This study therefore fills an important gap.
Our finding that higher pain during the IUD insertion procedure was the only variable consistently associated with reduced odds of satisfaction with the IUD insertion procedure suggests that pain reduction interventions may be important for young women. Moreover, the finding that younger adolescents and those with no prior gynecologic examination were less likely to be satisfied with the IUD insertion procedure suggests that patients with these characteristics, in particular, may derive benefit from routine use of a paracervical block, other interventions designed to enhance procedure tolerance, or the opportunity to undergo IUD placement under sedation. In the current study, a 10-mL paracervical block with 1% lidocaine was used. Future studies should consider examining the effectiveness of other pain control interventions that are currently understudied in this population, including the four-site paracervical block, lidocaine spray or gel applied to the cervix before placing a paracervical block, or using a higher dose of a lidocaine paracervical block.
We found no differences in patient satisfaction in the sham block group and paracervical block group despite the sham group reporting significantly more pain with the procedure. Similar to our study, prior randomized controlled trials assessing the effectiveness of various pain medications in reducing pain during IUD insertion have consistently noted high rates of satisfaction with the IUD insertion procedure, regardless of the pain control regimen used.17,23,24 None of these studies, including our current study, assessed how motivated women were to have an IUD placed. Patients who are highly motivated to get an IUD may report high satisfaction as a result of receiving the contraceptive method of their choice, despite experiencing pain during the insertion procedure. Assessing young women's motivations for using an IUD is an underexplored area that may be important for better understanding the relationship between patient satisfaction and reported pain.
There are a number of limitations in the current study. Although there are four hormonal IUDs on the market, we examined satisfaction with insertion of only the 13.5-mg levonorgestrel IUD; these findings may not extend to other types of IUDs. We only examined satisfaction immediately after the IUD insertion, but patient satisfaction might change over time. In particular, participants' perception that going through the IUD insertion process was worth the discomfort and their willingness to recommend an IUD to a friend might change depending on their experience with the method over time. Another key limitation was that our study was powered to assess pain control, not patient satisfaction. It is possible that had we powered the study to assess patient satisfaction, we may have seen different results. Young age (age 14–17 years) was noted to be associated with decreased overall satisfaction, but the small size of this group (less than one fourth of analyzed participants) likely limited subgroup analyses by age. Finally, there are some predictors that may influence patient satisfaction that we could not analyze as a result of too few of our participants reporting those predictors. If we had a larger sample size, predictors such as anxiety or depression may have influenced patient satisfaction.
Adolescents and young women report high overall satisfaction with the IUD insertion procedure, whether or not they receive a paracervical block. Although younger age, lack of experience with a gynecologic examination, and higher pain were inversely associated with satisfaction, most young women consider receiving an IUD to be worth the discomfort. Future research should evaluate satisfaction with the IUD over a longer time period as well as other interventions to improve the IUD insertion experience for younger adolescents.
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