LI4 Acupuncture for Analgesia in Intrauterine Device Insertion

October 2, 2021 updated by: Pınar Erdoğan, Nigde Omer Halisdemir University

Does LI4 Acupuncture Provide an Effective Analgesia During Intrauterine Device

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Niğde, Turkey
        • Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture Group
Bilateral LI4 acupuncture is administered before IUD insertion. Pain perception is evaluated by 10 points rated VAS after completion of the procedure.
Procedure: Acupuncture
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.
No Intervention: Control Group
IUD insertion is proceeded without any intervention. Pain perception is evaluated by 10 points rated VAS after completion of the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain perception
Time Frame: At the 3rd minute after IUD insertion is completed
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
Time Frame: At the 10th minute after IUD insertion is completed
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2021

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 2, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08.06.2021/30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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