Review
Material and methods
The scoping review methodology was performed in accordance with the Joanna Briggs Institute (JBI) standards, ensuring a thorough examination of the literature regarding IUD insertion, pain management, and nulliparous women. The JBI methodology utilizes an evidence-based approach that considers the feasibility, appropriateness, meaningfulness, and effectiveness (FAME) of each article. The base search strategy was constructed by analyzing key terms in Covidence and from relevant articles in Cumulated Index in Nursing and Allied Health Literature (CINAHL), Medline, Web of Science, and Embase. The researchers then limited articles to those written between 2014 and 2024. To meet inclusion criteria, articles had to be peer-reviewed, written in English, and based on research studies taking place at any time within the last 10 years. Other criteria included women of at least 18 years of age, nulliparous, and receiving their first IUD with no contraindications, such as pelvic inflammatory disease and pregnancy.
Researchers performed the initial search on September 12, 2023, and used the Population, Intervention, Comparison, Outcomes, and Study (PICOS) design as a framework to formulate eligibility criteria. Initially, electronic databases such as CINAHL, Medline, Web of Science, and additional databases within Embase were searched for articles published within the last five years using the Boolean phrase (IUD insertion OR (iud AND insertion)) AND (pain control OR (pain AND control) OR analgesia OR anesthesia) AND (nulliparous OR nulliparity). However, there was an inadequate number of sources found. A second search expanded to the last 10 years, using the same Boolean phrase, of case reports, clinical trials, comparative studies, and randomized controlled trials, which yielded 240 articles. From the initial search, 139 duplicates were removed and 101 articles remained for screening. Additionally, researchers excluded 72 articles that did not meet inclusion criteria, such as multiparous women, or studies not conducted within the last 10 years, and two articles that could not be accessed. From the remaining 29 articles, the researchers were able to eliminate 13 resources due to the following reasons - two studies took place outside of the specified time frame, one study was not written in the English language, four studies had the wrong study design, and four studies included the wrong patient population, such as multiparous women. The reviewers then discussed each full-text article that was being considered for inclusion. After studies were screened and assessed in full text for eligibility, the researchers determined that 16 studies were able to be included in the review.
The two authors then conducted the third research stage independently using Covidence to organize the results of the 16 studies. The search strategy was reviewed with a physician to ensure that the search question was relevant to clinical obstetrics and phrased correctly. Data were extracted on article characteristics, types of intervention used during IUD insertion, and results of pain during various stages, including during and after IUD insertion. Researchers used Covidence to organize the summaries and analyses, including, population, study design, measures, and findings of the chosen articles.
Figure 1 shows the preferred reporting items for systematic reviews and meta-analyses (PRISMA) flow diagram to demonstrate the search methods utilized by the research team. Within the 16 studies of review, researchers grouped findings based on treatment modality, including oral analgesics, cervical blocks, and cervical softening with dilation.
Results
After further analysis of the results from the selected articles in this systematic review, researchers found that there were three main strategies used for the management of pain during IUD insertion. Most commonly, these included oral analgesics, such as ibuprofen or tramadol, cervical blocks with lidocaine, and softening and dilation of the cervix with the use of prostaglandins.
Characteristics of Included Studies
The 16 studies that were included in the study were conducted between 2014 and 2024. The selected studies were all randomized controlled trials (n=16). The included studies were completed in the United States of America (n=6), Egypt (n=4), Brazil (n=2), Israel (n=1), Switzerland (n=1), France (n=1), and Sweden (n=1). There were no notable demographic differences noted amongst any of the studies. The characteristics of the included studies are summarized in Table 1 .
RCT: Randomized controlled trial; IUD: Intrauterine device
Quality Assessment of Studies
The quality of the 16 eligible studies was evaluated using the quality assessment feature on Covidence. Each of the studies was assigned a quality assessment value out of the possible poor, fair, and good ratings and assessed based on randomization, treatment of concealment, blinding of participants and personnel, blinding of outcome assessors, incomplete outcome data, selective outcome reporting, and other extra sources of bias. Each of the studies utilized in this review received a quality assessment value of good.
Level of Pain Control with Oral Analgesics
The use of oral analgesics, specifically 800 mg of ibuprofen one hour prior to the procedure, is currently recommended prior to an IUD insertion. However, the data surrounding the clinical significance of pain reduction with the use of oral analgesics are contradictory, with some studies supporting the use of oral analgesics and other studies showing no significant pain reduction with the use of oral analgesics. The use of 50 mg of tramadol one hour prior to IUD insertion was not found to have any clinical significance on pain reduction during the IUD insertion procedure (p=0.610) [ 4 ]. However, it was found that 550 mg of naproxen sodium taken prior to the insertion procedure led to a clinically significant reduction in pain post IUD insertion with average visual analog scale (VAS) scores of 26 and 16.5 for the control and treatment groups, respectively (p=0.01). However, this intervention did not provide any significant pain relief during cervical grasping (p=0.97) or during the actual insertion procedure (p=0.89) [ 5 ].
Level of Pain Control with Cervical Blocks
Cervical blocks are also a method of pain control that can be offered to individuals undergoing an IUD insertion. However, the use of a cervical block is not a standard procedure as a method of pain control. Studies that measured pain management with cervical blocks show inconsistent results. One study found that using 20 cc of buffered 1% lidocaine injected into the cervix led to a clinically significant reduction in pain during IUD insertion with average VAS scores for the control and treatment groups being 54 and 33, respectively (p=0.001). This study also showed a statistically significant reduction in pain post IUD insertion with the average VAS scores for the control and treatment groups being 27 and 12, respectively (p=0.005). However, there was no significant reduction in pain with cervical grasping when 1% lidocaine was injected into the cervix (p=0.268) [ 6 ]. Another study found that the use of 2% lidocaine injected into the cervix did not lead to any significant reduction in pain during IUD insertion (p=0.4) or post IUD insertion (p=0.1) [ 7 ]. Alternatively, another study found that the use of 3.6 mL of 2% lidocaine was associated with a significant reduction in pain with cervical grasping, IUD insertion, and pain control post IUD insertion. This study compared three groups: a group receiving a sham block, a group receiving a lidocaine block, and a group receiving no intervention. This study reported pain levels based on participants' classification of pain as mild, moderate, or severe pain. During tenaculum placement, 2% of the participants who received 2% lidocaine reported severe pain, while 30.2% of participants in the sham block group reported severe pain, and 15.2% of participants who received no intervention reported severe pain (p<0.0001). During IUD insertion, 26.5% of participants receiving the 2% lidocaine experienced severe pain, 59.4% of participants receiving the sham block experienced severe pain, and 50.5% of the participants who received no intervention experienced severe pain (p<0.0001) [ 8 ]. Another study compared the use of sole usage of 800 mg of ibuprofen with the usage of a combination of 800 mg of ibuprofen with 1 mL of 1% lidocaine at the tenaculum site and 4.5 mL of 1% lidocaine at the cervicovaginal junction. The results from this study show that the average VAS scores during tenaculum placement were 60 and 23.5 for the control and treatment groups, respectively (p<0.001). The average VAS scores during IUD insertion were 71.5 and 30 for the control and treatment groups, respectively (p<0.001). The average VAS scores post IUD insertion were 29 and 5 for the control and treatment groups, respectively (p<0.001) [ 9 ]. Lastly, a study comparing the use of 10 mL of 1% mepivacaine to placebo did not result in any significant pain management during cervical grasping (p=0.487), IUD insertion (p=0.062), or post IUD insertion (p=0.545) [ 10 ]. Furthermore, the injection of lidocaine, or another analgesic, into the cervix causes pain when the needle penetrates the cervix. For this reason, the use of lidocaine in the form of gel was also studied in order to prevent the pain that is associated with injecting analgesics into the cervix. The first study analyzing the use of analgesic gel found that using dual responsive in situ lidocaine gel led to a significant reduction in pain with cervical grasping, IUD insertion, and post IUD insertion. The average VAS scores for the control and treatment groups with cervical grasping were four and two, respectively (p=0.001). The average VAS scores for the control and treatment groups with IUD insertion were six and three, respectively (p=0.001). The average VAS scores for the control and treatment groups post IUD insertion were 2.5 and 1, respectively (p=0.001) [ 11 ]. The use of 4 mL of 2% lidocaine gel self-administered vaginally also led to a significant reduction in pain with cervical grasping, with average VAS scores of 56 and 32 for the control and treatment groups, respectively (p=0.03). However, there was no significant reduction in pain with IUD insertion (p=0.13) or pain post IUD insertion (p=0.52) [ 12 ].
Level of Pain Control with Innovative Techniques
There were also some studies that evaluated the level of pain control with innovative techniques that are not offered to individuals or routinely used during the IUD insertion procedure. One study examined the use of a cervical suction stabilizer rather than a tenaculum to grasp the cervix during IUD insertion. This study found that there was a clinically significant reduction in pain during cervical grasping with average VAS scores of 39 vs 11 for control and treatment groups (p<0.001), respectively, and during IUD insertion with average VAS scores of 57.8 vs 32.4 for control and treatment groups, respectively (p<0.001). However, there was no significant reduction in pain post IUD insertion when using a cervical suction stabilizer (p=0.100). In addition, this study found that there was significantly more cervical bruising with the use of the cervical suction stabilizer compared to the use of a tenaculum with 8 out of the 28 participants in the treatment group developing ecchymosis of the cervix, while none of the participants in the control group developed ecchymosis of the cervix [ 13 ]. Another study evaluated the use of nitroglycerin ointment on the cervix, which demonstrated no significant reduction in pain during the IUD insertion procedure (p=0.82) [ 14 ]. Another study evaluated the use of a cold compress applied to the abdomen for five minutes prior to IUD insertion. This study found no significant reduction in pain during the IUD insertion procedure (p=0.805) [ 15 ]. The last study compared the use of virtual reality and no standard treatment with just standard treatment. The findings from this study determined that there was significant pain reduction with the use of virtual reality during the IUD insertion procedure (p=0.54) [ 16 ].
Level of Pain Control with Cervical Softening and Dilation
Another method of pain control that is offered to some individuals is prostaglandins, which function to soften and dilate the cervix so that the insertion of the IUD is theoretically less painful. One research group completed three studies comparing the use of two prostaglandin E2 medications, dinoprostone, and misoprostol, administered at various time points prior to the insertion procedure. One of these studies compared vaginal administration of a placebo pill with vaginal administration of a 3 mg dinoprostone pill 12 hours prior to the IUD insertion procedure. The results from this study demonstrated a significant reduction in pain during cervical grasping and IUD insertion with the use of both dinoprostone. However, there was no significant reduction in pain post IUD insertion (p=0.59), and participants did experience significantly more abdominal cramping than the control group. During cervical grasping, this study found average VAS scores of 4.55 vs 2.97 for the control and treatment groups, respectively (p<0.001). During IUD insertion, this study found average VAS scores of 3.95 vs 2.83 for the control and treatment groups, respectively (p<0.01) [ 17 ]. The second study compared the use of 3 mg of dinoprostone administered vaginally six hours prior to the procedure with vaginal administration of a placebo pill and found that there was a significant reduction in pain with IUD insertion, with the average VAS scores with IUD insertion being 5 and 3.7, respectively (p<0.01). However, pain control with cervical grasping and post IUD insertion was not measured [ 18 ]. The third study compared the use of vaginally administered 3 mg of dinoprostone with the use of vaginally administered 3 mg of misoprostol with vaginally administered placebo, each administered three hours prior to the insertion procedure. This study found that there was a significant reduction in pain during cervical grasping, IUD insertion, and post IUD insertion. With cervical grasping, the average VAS scores for the control vs 3 mg misoprostol vs 3 mg dinoprostone were 4 vs 3.2 vs 2.2, respectively (p<0.001). With IUD insertion, the average VAS scores were 4.4, 2.4, and 3.1, respectively (p=0.02 ). Post IUD insertion, the average VAS scores were 3.4, 2.7, and 2.0, respectively (p<0.001) [ 19 ].
Discussion
Current guidelines for pain management during intrauterine device insertions only indicate the administration of 800 mg of ibuprofen one hour prior to the procedure [ 2 ]. However, the research surrounding the advantages of using ibuprofen is contradictory, with not many patients having any significant pain reduction with the use of 800 mg of ibuprofen. In addition, other studies that measured the effects of oral analgesics did not find any clinically significant reductions in pain levels among participants, which suggests that oral analgesics are not a completely effective method to manage pain during IUD insertions [ 4 , 5 ]. The use of cervical blocks as a pain management technique is also contradictory. In one study, injection of 2% lidocaine into the cervix yielded clinically significant pain management during the IUD insertion procedure [ 8 ]. In addition, there was another study that used 800 mg of ibuprofen with a total of 4.5 mL of 1% lidocaine injected into the cervix, and this study showed that this combination significantly reduced pain during the IUD insertion procedure [ 9 ]. However, another study determining the effects of the injection of 2% lidocaine into the cervix showed that there was no clinically significant reduction in pain during any portion of the IUD insertion [ 7 ]. Due to the conflicting evidence, there is minimal support for the use of injected lidocaine into the cervix, especially given that the injection itself would cause the patient discomfort. However, one study determining the effects of dual responsive in situ lidocaine gel found that there was clinically significant pain reduction during the procedure. In addition, since this study used lidocaine gel on the participants rather than lidocaine injections, there is the additional benefit of no discomfort during the injection of lidocaine. For this reason, the application of lidocaine gel appears to be advantageous to an individual's pain management during the IUD procedure [ 11 ]. However, as there was only a singular study completed on the application of in situ lidocaine gel prior to IUD insertions, it would be beneficial to complete future research studies analyzing the effects of lidocaine gel during IUD insertion procedures in order to confirm the findings in the initial study.
New and innovative techniques being studied for the first time were also included in this review. One of those new techniques was the use of a cervical suction stabilizer, rather than a tenaculum, to grasp the cervix. According to patients, one of the most painful steps of the IUD insertion procedure is when the tenaculum is used to grasp the cervix. This study used suction, rather than a tenaculum, to grasp the cervix in an attempt to mitigate the pain associated with the use of the tenaculum. The results from this study showed a clinically significant decrease in pain during both cervical grasping and IUD insertion. However, it is to be noted that there were more instances of cervical ecchymosis with the use of the cervical suction stabilizer rather than the tenaculum [ 13 ]. Despite the resulting ecchymosis, the benefits of pain management with the cervical suction stabilizer make this technique a good option for providers looking to improve patient satisfaction during IUD insertion. Other innovative techniques such as using virtual reality, using cold compresses on the abdomen, and using nitroglycerin ointment on the cervix were also studied [ 14 - 16 ]. However, none of these studies demonstrated any clinically significant changes in pain during the IUD insertion procedure. Therefore, these techniques do not have any evidence supporting their use in the clinical setting. However, because these are innovative techniques with the potential for improvement, other studies could be done to measure the effects of these techniques as they improve. Specifically, virtual reality is an up-and-coming technology that is continually making advances. As these advances continue, there may be more benefits of using virtual reality as both a relaxation and pain management technique for IUD insertions in the future.
Lastly, the use of prostaglandins showed advantageous effects on pain management during IUD insertion. Both the use of vaginal dinoprostone and vaginal misoprostol showed clinically significant reductions in pain during the IUD insertion procedure. There were three different studies comparing these medications to a placebo, and they were tested when given at three hours, six hours, or 12 hours prior to the procedure. All three studies showed clinically significant improvement in pain during the procedure, suggesting that there is no advantage or disadvantage to administering these medications at different time intervals [ 17 - 19 ]. In addition, this is one of the options that actually provides benefits, in regards to pain management during the IUD insertion procedure, and should therefore be heavily considered as an option for pain control. However, these medications cause additional discomfort in the way of abdominal cramping. Thus, if these medications were to be utilized as a method of pain management during IUD insertion procedures, the benefits would have to be weighed with the disadvantages of the added abdominal cramping. In addition, the three studies comparing the use of dinoprostone and misoprostol to placebo were only completed by one research group. For this reason, bias needs to be considered as a possibility for the positive outcomes of the studies [ 17 - 19 ]. However, because there were positive outcomes to the studies, it would be beneficial to complete future studies analyzing the use of dinoprostone and misoprostol during IUD insertions to accurately determine whether or not the use of these medications would actually be of clinical benefit to patients receiving an IUD insertion.
Although there were some studies that found significant results in pain management during IUD insertions, further studies should be done to strengthen the power of these results since many of the studies that were included in this review contain low sample sizes. Abd Ellah et al., who found a significant reduction in pain during the IUD insertion procedure, had a sample size of 48 [ 11 ]. Samy et al., who found a significant reduction in pain during IUD insertions when using dinoprostone or misoprostol, had sample sizes of 118, 200, and 130 in three studies, respectively [ 17 - 19 ]. Yaron et al., who found a significant reduction in pain during IUD insertions when using a cervical suction grasper, had a sample size of 55 [ 13 ]. In order to support the findings in these studies, further critical evaluation of the use of these techniques during IUD insertions is necessary.
Limitations
The inclusion criteria indicated that articles had to be peer-reviewed, written in English, and written within the last 10 years. Based on the inclusion criteria, the scoping review was limited to analyzing only 16 articles. The limited amount of articles consequently led to a limited sample size and outcomes assessed for each modality of pain management. Limitations specific to the various articles are outlined in the results section above. Additionally, the study criteria limited the participants to be women of at least 18 years of age and nulliparous.
Future Research Implications
Future research may benefit by including a measurement of preconceived pain or anxiety about IUD insertion to assess whether they play a role in the overall pain experienced during IUD insertion. Researchers could also combine oral analgesic pain control and either cervical block or cervical softening to optimize the management of pain control during and after IUD insertion. This approach has the potential to improve patient satisfaction with IUD insertion. Additionally, in the future, there have been some studies that have found that transcutaneous electrical nerve stimulation (TENS) may play a beneficial role in decreasing pain during IUD insertion [ 20 ]. Overall, a decrease in pain and an increase in patient satisfaction may ultimately encourage more women to get an IUD, which can play a beneficial role in women who experience menstrual complications such as cramping and anemia.