LI4 Acupuncture for Analgesia in Intrauterine Device Insertion

NCT04963582 | Completed

• 1 other identifier: 08.06.2021/30
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Pain during IUD insertion is substantially psychologic in origin, responds extremely well to non-pharmacologic interventions. Considering the fact that acupuncture is a modality exerting both psychologic and physiologic effects, the authors presume that acupuncture administration before IUD insertion may have positive effects on pain control. From this point of view, the aim of this study to investigate the effects of LI4 acupuncture administered shortly before IUD insertion on pain perception and discomfort of the women.

Conditions

IUD Insertion Complication; Acute Pain

Keywords

IUD insertion; Acupuncture; Pain management; Acute pain

Outcome Measures

Primary Outcomes (2)

• Pain perception

  Pain perception is measured by using 10-point rated Visuel Analog Scale. Zero point in the scale refers to no pain whereas 10 points refers to worst pain experienced by the patient.

  At the 3rd minute after IUD insertion is completed

• Pain perception

  Pain perception is measured by using 10-point rated Visuel Analog Scale. Zero point in the scale refers to no pain whereas 10 points refers to worst pain experienced by the patient.

  At the 10th minute after IUD insertion is completed

Study Arms (2)

Acupuncture Group

EXPERIMENTAL

Bilateral LI4 acupuncture is administered before IUD insertion. Pain perception is evaluated by 10 points rated VAS after completion of the procedure.

Procedure: Acupuncture

Control Group

NO INTERVENTION

IUD insertion is proceeded without any intervention. Pain perception is evaluated by 10 points rated VAS after completion of the procedure.

Interventions

Acupuncture PROCEDURE

LI4 is located on the dorsum of the hand, midway between the 1st and 2nd metacarpal bones, approximately in the middle of the 2nd metacarpal bone on the radial side. Acupuncture is practiced by using 0,25x25mm sized needles. LI4 point is punctured perpendicularly 2cm in the direction of the palm center.

Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who wish to use IUD as contraception and who refer to Community Health Center for the procedure of IUD insertion.

You may not qualify if:

• Women who use anti-coagulant drugs or who have blood diseases.
• Women with dermatologic lesions on the area of LI4 point location.
• Women with previously diagnosed neurologic diseases.

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Community Health Center

Niğde, Turkey (Türkiye)

Location

Related Publications (16)

• Miles SM, Shvartsman K, Dunlow S. Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial. Contracept Reprod Med. 2019 Sep 10;4:13. doi: 10.1186/s40834-019-0094-0. eCollection 2019.

  PMID: 31516731 RESULT

• Bracken J, Graham CA. Young women's attitudes towards, and experiences of, long-acting reversible contraceptives. Eur J Contracept Reprod Health Care. 2014 Aug;19(4):276-84. doi: 10.3109/13625187.2014.917623. Epub 2014 Jun 2.

  PMID: 24882426 RESULT

• Dijkhuizen K, Dekkers OM, Holleboom CA, de Groot CJ, Hellebrekers BW, van Roosmalen GJ, Janssen CA, Helmerhorst FM. Vaginal misoprostol prior to insertion of an intrauterine device: an RCT. Hum Reprod. 2011 Feb;26(2):323-9. doi: 10.1093/humrep/deq348. Epub 2010 Dec 15.

  PMID: 21159683 RESULT

• Ngo LL, Ward KK, Mody SK. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):29-36. doi: 10.1097/AOG.0000000000000912.

  PMID: 26241253 RESULT

• Daykan Y, Battino S, Arbib N, Tamir Yaniv R, Schonman R, Klein Z, Pomeranz J, Pomeranz M. Verbal analgesia is as good as oral tramadol prior to intrauterine device (IUD) insertion, among nulliparous women: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2021 Mar;258:443-446. doi: 10.1016/j.ejogrb.2020.09.019. Epub 2020 Sep 16.

  PMID: 33187752 RESULT

• Abu-Zaid A, Alshahrani MS, Albezrah NA, Miski NT, Abuzaid M, Aboudi SA, Baredwan A, Almadhi N, Baradwan A, Alomar O, Salem H, A Al-Badawi I, Baradwan S. Vaginal dinoprostone versus placebo for pain relief during intrauterine device insertion: a systematic review and meta-analysis of randomised controlled trials. Eur J Contracept Reprod Health Care. 2021 Oct;26(5):357-366. doi: 10.1080/13625187.2021.1891411. Epub 2021 Mar 11.

  PMID: 33691549 RESULT

• Lopez LM, Bernholc A, Zeng Y, Allen RH, Bartz D, O'Brien PA, Hubacher D. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015 Jul 29;2015(7):CD007373. doi: 10.1002/14651858.CD007373.pub3.

  PMID: 26222246 RESULT

• Goldstuck ND. Pain reduction during and after insertion of an intrauterine contraceptive device. Adv Contracept. 1987 Mar;3(1):25-36. doi: 10.1007/BF01849250.

  PMID: 3630817 RESULT

• Origoni M, Leone Roberti Maggiore U, Salvatore S, Candiani M. Neurobiological mechanisms of pelvic pain. Biomed Res Int. 2014;2014:903848. doi: 10.1155/2014/903848. Epub 2014 Jul 8.

  PMID: 25110704 RESULT

• Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007 Jul;133(4):581-624. doi: 10.1037/0033-2909.133.4.581.

  PMID: 17592957 RESULT

• Hunter TA, Sonalkar S, Schreiber CA, Perriera LK, Sammel MD, Akers AY. Anticipated Pain During Intrauterine Device Insertion. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):27-32. doi: 10.1016/j.jpag.2019.09.007. Epub 2019 Sep 26.

  PMID: 31563628 RESULT

• Dina B, Peipert LJ, Zhao Q, Peipert JF. Anticipated pain as a predictor of discomfort with intrauterine device placement. Am J Obstet Gynecol. 2018 Feb;218(2):236.e1-236.e9. doi: 10.1016/j.ajog.2017.10.017. Epub 2017 Nov 8.

  PMID: 29079143 RESULT

• Andersson S, Lundeberg T. Acupuncture--from empiricism to science: functional background to acupuncture effects in pain and disease. Med Hypotheses. 1995 Sep;45(3):271-81. doi: 10.1016/0306-9877(95)90117-5.

  PMID: 8569551 RESULT

• Ter Riet G, de Craen AJM, de Boer A, Kessels AGH. Is placebo analgesia mediated by endogenous opioids? A systematic review. Pain. 1998 Jun;76(3):273-275. doi: 10.1016/S0304-3959(98)00057-8.

  PMID: 9718245 RESULT

• Han JS, Terenius L. Neurochemical basis of acupuncture analgesia. Annu Rev Pharmacol Toxicol. 1982;22:193-220. doi: 10.1146/annurev.pa.22.040182.001205. No abstract available.

  PMID: 7044284 RESULT

• Erdogan P, Yardimci H. Analgesic effects of LI4 acupuncture during intrauterine device insertion: a randomized controlled clinical trial. Arch Gynecol Obstet. 2023 Oct;308(4):1361-1368. doi: 10.1007/s00404-023-07106-5. Epub 2023 Jul 19.

  PMID: 37466690 DERIVED

MeSH Terms

Conditions

Acute Pain; Agnosia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Pınar Erdoğan, MD

  Niğde Ömer Halisdemir University Midwifery Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Case-controlled

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 15, 2021
• Study Start: July 5, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)