search
Back to results

LI4 Acupuncture for Analgesia in Intrauterine Device Insertion

Primary Purpose

IUD Insertion Complication, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Nigde Omer Halisdemir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IUD Insertion Complication focused on measuring IUD insertion, Acupuncture, Pain management, Acute pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Community Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 5, 2021
Last Updated
October 2, 2021
Sponsor
Nigde Omer Halisdemir University
search

1. Study Identification

Unique Protocol Identification Number
NCT04963582
Brief Title
LI4 Acupuncture for Analgesia in Intrauterine Device Insertion
Official Title
Does LI4 Acupuncture Provide an Effective Analgesia During Intrauterine Device
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nigde Omer Halisdemir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Intrauterine devices (IUDs) are one the most preferred, most effective and reversible contraceptive methods with long term effects. The major drawback of women for IUD use is the pain anticipation during insertion of the device. Studies using visual analog scale (VAS) demonstrated that pain perception during IUD insertion varied between 2-7 score. Surprisingly there are only limited number of studies on pain management during IUD insertion which is an ambulatory and out-patient gynecologic procedure. Besides the results of present studies contradict with each other. As a result, a standardized protocol is lacking for pain management in IUD insertion [1]. Currently, most of the IUDs are administered in Community Health Centers (CHC) in our country and no modality for pain control is applied before or after IUD insertion. In case of necessity intramuscular or oral analgesic drugs are prescribed. In a long-standing review on the basics of this issue, it is concluded that the cervical component of pain perception during IUD insertion is psychologic rather than pathologic, is un-responsive to oral non-steroidal anti-inflammatory drugs and could be deducted via psyche-prophylactic methods. similar results were presented with studies undertaken In the advancing years. A recent study demonstrated that verbal inspiration techniques were as effective as oral tramadol for pain management in IUD insertion. Additionally, the effects of anticipation of pain on perception of pain is essential as well. Because in a large scale study, the results showed that one point increments in the VAS for anticipated pain resulted in an increase of pain perception by 19,7%. Therefore, the fact that psychologic, biologic, cognitive, behavioral, emotional and social factors interfere with pain perception is well-known and it is recommended by clinicians that these factors should be taken into consideration in processes of selecting modalities for pain management. Scientists research for the mechanism of pain control that acupuncture provides. Acupuncture is extremely effective in autonomic nerve regulation. Also, crucial effects of afferent information within somatic nerve fibers on autonomic functions were demonstrated on experimental and clinical studies. Acupuncture relies on biology based physiologic and psychologic mechanisms. It causes both the secretion of oxytocin and endogen opioids that induce functional changes in various organ systems and rhythmic changes in vulnerable tissues via the stimulation of receptors or nerve fibers. Acupoint LI4 is the most intensely studied, hte most preferred for analgesia and is the most used acupoint in routine daily practice. Studies on pain management in cases of chest tube pain, dental pain or multiple sclerosis were undertaken using LI4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IUD Insertion Complication, Acute Pain
Keywords
IUD insertion, Acupuncture, Pain management, Acute pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case-controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture Group
Arm Type
Experimental
Arm Description
Bilateral LI4 acupuncture is administered before IUD insertion. Pain perception is evaluated by 10 points rated VAS after completion of the procedure.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
IUD insertion is proceeded without any intervention. Pain perception is evaluated by 10 points rated VAS after completion of the procedure.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain perception
Description
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.
Time Frame
At the 3rd minute after IUD insertion is completed
Title
Pain perception
Description
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.
Time Frame
At the 10th minute after IUD insertion is completed

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women who wish to use IUD as contraception and who refer to Community Health Center for the procedure of IUD insertion. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pınar Erdoğan, MD
Organizational Affiliation
Niğde Ömer Halisdemir University Midwifery Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health Center
City
Niğde
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31516731
Citation
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.
Results Reference
result
PubMed Identifier
24882426
Citation
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.
Results Reference
result
PubMed Identifier
21159683
Citation
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.
Results Reference
result
PubMed Identifier
26241253
Citation
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.
Results Reference
result
PubMed Identifier
33187752
Citation
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.
Results Reference
result
PubMed Identifier
33691549
Citation
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.
Results Reference
result
PubMed Identifier
26222246
Citation
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.
Results Reference
result
PubMed Identifier
3630817
Citation
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.
Results Reference
result
PubMed Identifier
25110704
Citation
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.
Results Reference
result
PubMed Identifier
17592957
Citation
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.
Results Reference
result
PubMed Identifier
31563628
Citation
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.
Results Reference
result
PubMed Identifier
29079143
Citation
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.
Results Reference
result
PubMed Identifier
8569551
Citation
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.
Results Reference
result
PubMed Identifier
9718245
Citation
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.
Results Reference
result
PubMed Identifier
7044284
Citation
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.
Results Reference
result

Learn more about this trial

LI4 Acupuncture for Analgesia in Intrauterine Device Insertion

We'll reach out to this number within 24 hrs