Clinical Observation on Auricular Acupressure for Primary Dysmenorrhea: A Study Protocol for a Randomized Clinical Trial

Abstract

Purpose

The objective of this study is to evaluate the immediate and time-dependent effects of AA in treating PD and assess its safety.

Methods/Design

This study is a randomized, single-blinded, controlled trial that will enroll 92 patients in a 1:1 allocation ratio. Patients will be assigned to either the treatment group (n=46) or the control group (n=46). During the first menstrual period, the treatment group will receive AA treatment, while the control group will receive sham AA treatment for 7 days. The second menstrual period will serve as the follow-up period. The primary outcome measure is the Visual Analog Scale (VAS) score 30 min after the first treatment. Secondary outcome measures include the VAS score immediately after the first treatment, onset time of analgesic effect, duration of pain, extra dosing rate of ibuprofen, and change of the Menstrual Distress Questionnaire (MDQ) score. The outcomes will be assessed at baseline, during the intervention period, and during the follow-up period.

Conclusion

The study results will provide evidence on the efficacy and safety of AA in managing PD by analyzing its immediate effect, time-effect relationship, and reduction of painkiller use.

Trial Registration

Chinese Clinical Trial Registry (ChiCTR2300069741).

Keywords:

• acupressure
• dysmenorrhea
• menstrual pain
• ear

Abbreviations

PD, Primary Dysmenorrhea; AA, Auricular Acupressure; VAS, Visual Analogue Scale; MDQ, Menstrual Distress Questionnaire; CAM, Complementary and Alternative Medicine; ChiCTR, Chinese Clinical Trial Registry; SPIRIT, Standard Protocol Items: Recommendations for Intervention Trials; AEs, Adverse Events; CRF, Case Report Form.

Data Sharing Statement

Data requested for public use will be available after publication.

Ethics and Dissemination

This study has been approved by Medical Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (Approval number 2023-011), and will be carried out in conformity with the Declaration of Helsinki. Prior to signing the informed consent, patients will receive complete information about the trail. Results of the trial will be published in peer-reviewed journals.

Acknowledgments

The trial was registered at China Clinical Trials Registry on March 24, 2023 (ChiCTR2300069741). The date of the intended trial period is from 1 April 2023 to 1 December 2023. Patient recruitment began on 7 April 2023 and is currently ongoing.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.