LI4 Acupuncture for Pain During Intrauterine Device Insertion

Condition(s) studied

Investigational drug(s) / intervention(s)

LI4 Acupuncture: 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: 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.

Study summary

This study will evaluate whether acupuncture can reduce pain during intrauterine device (IUD) insertion. Women undergoing IUD insertion will be randomly assigned to receive either real acupuncture at the LI4 point on both hands or a sham acupuncture procedure that does not penetrate the skin. Both interventions will be applied for 15 minutes before IUD insertion. Participants will not know which treatment they receive. The clinician performing the IUD insertion and the researcher assessing the outcomes will also be unaware of the treatment assignment. Pain will be measured at different stages of the IUD insertion procedure and shortly after the procedure. The main outcome will be the highest pain score reported during IUD insertion. The study will also assess procedure tolerance, patient satisfaction, need for additional pain medication, and adverse events.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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