LI4 Acupuncture for Analgesia in Intrauterine Device Insertion
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|ClinicalTrials.gov Identifier: NCT04963582|
Recruitment Status : Completed
First Posted : July 15, 2021
Last Update Posted : October 5, 2021
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|Condition or disease||Intervention/treatment||Phase|
|IUD Insertion Complication Acute Pain||Procedure: Acupuncture||Not Applicable|
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 . 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 (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Case-controlled|
|Masking:||None (Open Label)|
|Official Title:||Does LI4 Acupuncture Provide an Effective Analgesia During Intrauterine Device|
|Actual Study Start Date :||July 5, 2021|
|Actual Primary Completion Date :||October 1, 2021|
|Actual Study Completion Date :||October 1, 2021|
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.
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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- Women who wish to use IUD as contraception and who refer to Community Health Center for the procedure of IUD insertion.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963582
|Community Health Center|
|Principal Investigator:||Pınar Erdoğan, MD||Niğde Ömer Halisdemir University Midwifery Department|
|Responsible Party:||Pınar Erdoğan, Principal Investigator, Nigde Omer Halisdemir University|
|Other Study ID Numbers:||
|First Posted:||July 15, 2021 Key Record Dates|
|Last Update Posted:||October 5, 2021|
|Last Verified:||October 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|