LI4 Acupuncture for Pain During Intrauterine Device Insertion

Pain during intrauterine device (IUD) insertion may affect procedure tolerance and patients' experience with this highly effective contraceptive method. Although several pharmacological approaches have been investigated for pain control during IUD insertion, their effectiveness has been inconsistent, and there is no universally accepted analgesic approach.

LI4 (Hegu) is an acupuncture point commonly used for analgesia. In a previous randomized controlled trial conducted by the investigators, bilateral LI4 acupuncture before IUD insertion was associated with lower post-procedural pain scores compared with no intervention. However, the absence of a sham control in that study did not allow specific effects of acupuncture to be distinguished from placebo and other nonspecific effects.

The present randomized, sham-controlled trial is therefore designed to evaluate the analgesic effect of bilateral LI4 acupuncture using a non-penetrating Park sham procedure as the comparator. The primary focus is pain experienced during the IUD insertion procedure. The sham-controlled and masked design is intended to reduce expectancy and assessment bias and provide a more rigorous estimate of the effect of LI4 acupuncture on procedure-related pain.

The IUD insertion procedure will be standardized across both study groups. No routine analgesic premedication will be administered before the procedure. IUD insertion will be performed according to the same standardized clinical protocol in all participants, including speculum placement, visualization of the cervix, tenaculum application, measurement of the uterine cavity, and IUD insertion. No analgesic medication will be routinely administered during the procedure. After completion of the scheduled pain assessments, an NSAID may be administered as rescue analgesia if clinically required, and its use will be recorded. Apart from the assigned acupuncture or sham acupuncture intervention, procedural management will be identical between the two groups.

• LI4 Acupuncture (Procedure): Bilateral acupuncture will be performed at the LI4 (Hegu) point 15 minutes before IUD insertion using sterile 0.25 × 25 mm acupuncture needles. Needles will be inserted to a depth of approximately 1.5-2 cm, and manual stimulation will be applied to elicit de qi. The needles will remain in place for 15 minutes and will then be removed before the IUD insertion procedure.
• Sham Acupuncture (Procedure): Bilateral sham acupuncture will be performed at the LI4 (Hegu) point 15 minutes before IUD insertion using Park-type non-penetrating sham needles. The sham needles will not penetrate the skin, and no de qi or manual stimulation will be elicited. The sham procedure will last 15 minutes and will be completed before IUD insertion. Treatment duration and participant-practitioner interaction will be standardized to match the LI4 acupuncture intervention.

Primary outcomes

• Maximum Procedure-Related Pain During IUD Insertion [During the IUD insertion procedure]: Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at three predefined procedural stages: tenaculum application, passage through the uterine cavity, and fundal placement of the IUD. For each participant, the highest VAS score recorded across these three stages will be defined as the maximum procedure-related pain score. Higher scores indicate greater pain.

Secondary outcomes

• Pain During Tenaculum Application [During tenaculum application]: Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), during tenaculum application. Higher scores indicate greater pain.
• Pain During Passage Through the Uterine Cavity [During passage through the uterine cavity]: Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), during passage through the uterine cavity. Higher scores indicate greater pain.
• Pain During Fundal Placement of the IUD [During fundal placement of the IUD]: Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), during fundal placement of the IUD. Higher scores indicate greater pain.
• Pain at 3 Minutes After IUD Insertion [3 minutes after completion of IUD insertion]: Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain.
• Pain at 10 Minutes After IUD Insertion [10 minutes after completion of IUD insertion]: Pain will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain.
• Occurrence of Vasovagal Reaction [During IUD insertion and through 10 minutes after the procedure]: Occurrence of a clinically observed vasovagal reaction associated with the IUD insertion procedure will be recorded as yes or no.
• Use of Rescue Analgesia [During IUD insertion and through 10 minutes after the procedure]: The need for rescue analgesic medication related to pain during or immediately after the IUD insertion procedure will be recorded as yes or no.
• Procedure Tolerance [10 minutes after completion of IUD insertion]: Participants will rate their overall tolerance of the IUD insertion procedure using an 11-point numerical rating scale ranging from 0 (completely intolerable) to 10 (completely tolerable). Higher scores indicate better procedure tolerance.
• Patient Satisfaction [10 minutes after completion of IUD insertion]: Participants will rate their overall satisfaction with the IUD insertion experience using an 11-point numerical rating scale ranging from 0 (not at all satisfied) to 10 (completely satisfied). Higher scores indicate greater satisfaction.
• Willingness to Choose the Same Method Again [10 minutes after completion of IUD insertion]: Participants will be asked whether they would choose the same contraceptive method again based on their current IUD insertion experience. Responses will be recorded as yes or no.
• Pain Compared With Preprocedural Expectation [10 minutes after completion of IUD insertion]: Participants will be asked to compare the pain experienced during IUD insertion with the pain they expected before the procedure. Responses will be categorized as less painful than expected, approximately as painful as expected, or more painful than expected.

Other outcomes

• Acupuncture-Related Adverse Events [From initiation of the acupuncture or sham procedure through 10 minutes after IUD insertion]: Adverse events potentially related to the acupuncture or sham acupuncture intervention will be assessed, including local pain, minor bleeding, hematoma, and dizziness. The occurrence of one or more of these events will be recorded for each participant.
• Participant Blinding Assessment [10 minutes after completion of IUD insertion, after completion of the other outcome assessments]: Participants will be asked to indicate which intervention they believe they received. Response options will be: real acupuncture, sham acupuncture, or do not know. The distribution of responses will be compared between randomized groups to assess the success of participant blinding.

Sex: Female, ages: 18 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

* Women aged 18-50 years
* Scheduled to undergo copper intrauterine device (IUD) insertion for contraception
* Able to communicate in Turkish
* Able to understand and use the Visual Analog Scale (VAS) for pain assessment
* Able and willing to provide written informed consent

Exclusion Criteria:

* Confirmed or suspected pregnancy
* Active pelvic infection
* Unexplained abnormal uterine bleeding
* Any contraindication to IUD insertion
* Use of opioid analgesic or sedative medication within the preceding 24 hours
* Known allergy or hypersensitivity to acupuncture needle materials
* Needle phobia
* Infection, wound, or other significant skin lesion at or near the acupuncture site
* Serious psychiatric disorder or cognitive impairment that may interfere with pain assessment or study participation
* Neurological disease or sequelae that may interfere with pain perception or pain assessment
* Requirement for an emergency procedure
* Previous participation in this study