Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea

Study Overview
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Brief Summary
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The objective of this study is to evaluate the associations between deqi, the effects of acupuncture and personality in primary dysmenorrhea and to characterize the nature of the deqi phenomenon on terms of the prevalence of sensations as well as the uniqueness of the sensations underlying the deqi experiment.

Detailed Description
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The mechanism, by which acupuncture works is not yet clear, therefore there is no unequivocal consensus about styles and sensations of acupuncture. whether psychological factor has influences on the effects of acupuncture? This study will adopt international practices such as visual analogue scale (VAS) to objective evaluation. The confident degree, feeling degree for acupuncture and pain intensity were evaluated by the patient with VAS, and the pain VAS scores before and after acupuncture were recorded as the indexes for assessment of the therapeutic effect.

Official Title
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Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Procedure: acupuncture, Deqi
* Procedure: acupuncture, Non-Deqi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, age between 18 and 30 years old, who had regular menstrual cycles (28-33 days); Meeting diagnostic criteria for primary dysmenorrhea, having moderate to severe symptoms when unmedicated, and eligible for care through the military health system. Exclusion Criteria: Secondary dysmenorrhea; Women with systemic disease, or hormonal, psychiatric or gynecologic disorders, or substance abuse; Pregnant or trying to conceive, using oral contraceptives, smoker, breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>In acupuncture treatment, immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the DeQi sensation, the needles are retained for 30 minutes. | Procedure: acupuncture, Deqi<br>* Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the DeQi sensation.<br>* Other names: Deqi;|
| Active Comparator: 2<br>In acupuncture treatment, immediately after insertion of a needle, it is NOT manually rotated backwards or forwards to induce the DeQi sensation, and retained for 30 minutes. | Procedure: acupuncture, Non-Deqi<br>* After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.<br>* Other names: Non-Deqi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale for pain intensity of primary dysmenorrhea |  | 90 days after onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average duration (hours) of pain |  | 90 days after onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Dysmenorrhea, Deqi, acupuncture, psychology