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耳穴按压(耳针疗法)对哺乳期妇女性功能的影响:一项随机假对照试验方案。

The effect of ear acupressure (auriculotherapy) on sexual function of lactating women: protocol of a randomized sham controlled trial.

机构信息

Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.

Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin, Iran.

出版信息

Trials. 2020 Aug 20;21(1):729. doi: 10.1186/s13063-020-04663-x.

Abstract

BACKGROUND

Lactation has a negative effect on female sexual function. Hormonal changes during lactation cause changes which might lead to dyspareunia, lack of libido, and anorgasmia. There are various pharmacological and non-pharmacological approaches to treat sexual dysfunction. While pharmacological treatment has multiple unwanted side effects, non-pharmacological therapies such as complementary medicine are a potential safer alternative. The aim of this study is to evaluate the effect of ear acupressure on sexual function of lactating women.

METHODS/DESIGN: This is a randomized clinical trial with a parallel sham control group. In this study, 76 lactating women between 6 months and 1 year after childbirth were referred to health care centers in Qazvin City and would be invited to participate. Participants will be divided into intervention (n = 38) and control (n = 38) groups using simple block randomization. Both intervention and sham control groups will be visited over 10 sessions within a 4-day interval. At each visit, the adhesives containing Vaccaria seed will be adhered for the intervention group, while non-latex-based adhesives with no Vaccaria seeds will be placed on the same ear acupoints for the sham control group. Selected ear acupoints include genitalia (two ear points), pelvic point, master shoulder, and posterior pituitary gland. The women will be asked to hold the seeds on their ears for 3 days and press each ear point three times a day for 20 s. After 3 days, they will be asked to remove the seeds from their ears and rest for 1 day. Sexual function as primary outcome in both groups will be assessed using the Female Sexual Function Index before and immediately after 1 and 2 months after the intervention. Also, Sexual Quality of Life as secondary outcome will be assessed using Sexual Quality of Life-Female (SQOL-F) before and 2 months after intervention. Data will be analyzed using repeated measure ANOVA at the significant level of 0.05.

DISCUSSION

This study is expected to support the impact of ear channel ear acupressure on sexual function in lactating women.

TRIAL REGISTRATION

Iranian Clinical Trial Registration Center IRCT20190626044028N1 . Registered on 16 August 2019.

摘要

背景

哺乳期对女性性功能有负面影响。哺乳期的激素变化会导致性交困难、性欲减退和性高潮障碍。有各种药物和非药物方法来治疗性功能障碍。虽然药物治疗有多种不良反应,但非药物治疗方法,如补充医学,是一种潜在更安全的选择。本研究旨在评估耳压对哺乳期妇女性功能的影响。

方法/设计:这是一项随机临床试验,采用平行假对照组。在这项研究中,76 名产后 6 个月至 1 年的哺乳期妇女被转介到卡齐万市的医疗保健中心,并将被邀请参加。参与者将通过简单的块随机分组分为干预组(n=38)和对照组(n=38)。两组均在 4 天的间隔内进行 10 次访问。在每次访问中,将为干预组贴上含有王不留行种子的贴片,而对照组则贴上不含王不留行种子的非乳胶贴片,贴在相同的耳穴上。选择的耳穴包括生殖器(两个耳点)、盆腔点、主肩和垂体后叶。妇女将被要求将种子贴在耳朵上 3 天,并每天按压每个耳点 3 次,每次 20 秒。3 天后,她们将被要求从耳朵上取下种子,休息 1 天。主要结局是干预前后、干预后 1 个月和 2 个月,采用女性性功能指数(Female Sexual Function Index)评估两组女性的性功能。次要结局是干预前后,采用女性性健康生活质量量表(Sexual Quality of Life-Female,SQOL-F)评估两组的生活质量。数据分析采用重复测量方差分析,显著性水平为 0.05。

讨论

本研究预计将支持耳穴耳压对哺乳期妇女性功能的影响。

试验注册

伊朗临床试验注册中心 IRCT20190626044028N1 。注册于 2019 年 8 月 16 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81b2/7441618/b3c5ebb33c42/13063_2020_4663_Fig1_HTML.jpg

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