Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

LI4 Acupuncture for Analgesia in Intrauterine Device Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04963582
Recruitment Status : Completed
First Posted : July 15, 2021
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Pınar Erdoğan, Nigde Omer Halisdemir University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
IUD Insertion Complication Acute Pain Procedure: Acupuncture Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Case-controlled
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Turkey
Community Health Center
Niğde, Turkey
Sponsors and Collaborators
Nigde Omer Halisdemir University
Investigators
Layout table for investigator information
Principal Investigator: Pınar Erdoğan, MD Niğde Ömer Halisdemir University Midwifery Department
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Pınar Erdoğan, Principal Investigator, Nigde Omer Halisdemir University
ClinicalTrials.gov Identifier: NCT04963582    
Other Study ID Numbers: 08.06.2021/30
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pınar Erdoğan, Nigde Omer Halisdemir University:
IUD insertion
Acupuncture
Pain management
Acute pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Pain
Pain
Neurologic Manifestations