Auricular acupressure and auricular acupuncture as an adjunct for pain management during first trimester aspiration abortion: A randomized, double-blinded, three-arm trial.

OBJECTIVES: To measure pain and anxiety during first trimester uterine aspiration when using auricular acupressure or acupuncture as an adjunct to usual care. METHODS: This randomized, double-blinded, three-arm trial enrolled patients undergoing an aspiration procedure for an induced abortion, a miscarriage, or other abnormal intrauterine pregnancy. Trial participants received auricular acupressure, auricular acupuncture, or placebo immediately prior to their procedures. The study began with 1:1:1 randomization, but later overenrolled into the acupressure group after providing retraining for greater fidelity to that intervention. All participants received ibuprofen and a paracervical block. Participants reported pain and anxiety levels via visual analog scores (0-100). Our analysis compared pain scores of those receiving acupressure versus placebo, and those receiving acupuncture versus placebo. RESULTS: We randomized 177 participants over nine months and excluded data from four participants. We analyzed data from 70 participants who received acupressure, 51 who received acupuncture, and 52 who received placebo. The groups had similar baseline characteristics, including baseline pain and anxiety scores. For acupressure, acupuncture, and placebo groups, respectively, immediate post-procedure median pain scores were 50, 55, 47.5 (p = 0.88); maximum pain scores during the procedure were 77, 79, 79.5 (p = 0.96); postprocedure anxiety scores were 26, 28, and 21 (p = 0.47). The acupressure group results were similar before and after retraining. CONCLUSIONS: Receiving auricular acupressure or acupuncture did not result in lower pain or anxiety scores among women undergoing vacuum aspiration compared to a placebo group. IMPLICATIONS: The results of this trial were null, thus differing from our previous study that had shown a benefit from auricular acupuncture. Given the conflicting results, incorporating these acupuncture techniques into abortion practice would be premature.

Factors associated with participant and provider pain rating during office-based first-trimester vacuum aspiration.

OBJECTIVE: The objective was to describe factors associated with reported pain and assess correlations between participant and provider pain assessments during first-trimester vacuum aspiration. STUDY DESIGN: Participants and providers in a trial evaluating music for pain reduction reported procedure-related pain using a 100-mm visual analog scale. RESULTS: The mean participant-reported maximum pain was 65.9±23.0 compared to 41.3±22.0 by provider assessment. Provider-reported scores correlated poorly with participant maximum pain (r=0.28) and participant maximum pain adjusted for baseline (r=0.27). Previous abortion (60.5 versus 71.4, p=.02) and immediate intrauterine device insertion (46.1 versus 68.6, p=.03) were associated with lower participant-reported pain. CONCLUSIONS: Providers underestimate pain reported during vacuum aspiration; provider estimates correlate poorly with participant self-report. IMPLICATIONS: To improve management of pain during first-trimester vacuum aspiration, we need to better understand factors that influence patient and provider pain rating. When assessing patient pain in this setting, providers should not assume a baseline of zero pain.

A randomized controlled trial of daily text messages versus monthly paper diaries to collect bleeding data after intrauterine device insertion.

OBJECTIVE: Bleeding data in contraceptive trials are often collected using daily diaries, but data quality may vary due to compliance and recall bias. Text messaging is a widespread and promising modality for data collection. STUDY DESIGN: This trial randomized participants 1:1 to use text messages or paper diaries to report on bleeding experienced during the 90 days after intrauterine device (IUD) insertion. Participants chose either the copper T380A or the 52-mg levonorgestrel IUD. Our primary outcome was number of days of reported bleeding data. We hypothesized that data gathered with daily text messages would have fewer missing values than paper diaries. Intention to treat analyses used the rank-sum test to compare medians. RESULTS: Two hundred thirty women enrolled, and randomization yielded groups similar in baseline characteristics. Twenty percent of participants provided no bleeding data; of these, 77% were assigned to paper diaries. With 90 days of reporting, approximately 20% in each group provided complete bleeding data. The text group reported a median of 82 days [interquartile range (IQR) 40-89] and the paper group reported a median of 36 days (IQR 0-88) (p≤.001). The number of responses received decreased gradually over the 90-day period but was always higher in the text group. Women who had attained higher levels of education did well regardless of data collection modality, while response rates of text messages were greater among those with a high school education or less (p<.01). CONCLUSIONS: Participants reporting bleeding via text messages provided more complete data than women using paper diaries. IMPLICATIONS: Depending on resources and population of interest, text messages may be a useful modality to improve data collection for patient-reported outcomes.