LI4 Acupuncture for Pain During Intrauterine Device Insertion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorNigde Omer Halisdemir University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Confirmed or suspected pregnancy
Active pelvic infection
Unexplained abnormal uterine bleeding
Any contraindication to IUD insertion
Trial design
Design model
Parallel
Treatments tested in this trial
LI4 Acupuncture
Procedure/SurgeryBilateral 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/SurgeryBilateral 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: LI4 AcupunctureExperimental treatment 1 intervention
Group B: Sham AcupunctureSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Procedure-Related Pain During IUD Insertion
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.
Time frame
During the IUD insertion procedureSecondary outcomes
1
Pain 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.
Time frame
During tenaculum application2
Pain 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.
Time frame
During passage through the uterine cavity3
Pain 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.
Time frame
During fundal placement of the IUD4
Pain at 3 Minutes After 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.
Time frame
3 minutes after completion of IUD insertionOther outcomes
1
Acupuncture-Related Adverse Events
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.
Time frame
From initiation of the acupuncture or sham procedure through 10 minutes after IUD insertion2
Participant Blinding Assessment
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.
Time frame
10 minutes after completion of IUD insertion, after completion of the other outcome assessmentsSponsors and contacts
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Source ClinicalTrials.gov
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