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干拔罐与基于正念认知疗法的咨询对多囊卵巢综合征不孕妇女生育质量和受孕成功率的疗效:一项初步随机临床试验。

Efficacy of Dry Cupping versus Counselling with Mindfulness-based Cognitive Therapy Approach on Fertility Quality of Life and Conception Success in Infertile Women due to Polycystic Ovary Syndrome: A Pilot Randomized Clinical Trial.

机构信息

Student Research Committee, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.

Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.

出版信息

Int J Community Based Nurs Midwifery. 2024 Jan 1;12(1):57-69. doi: 10.30476/IJCBNM.2023.100249.2351. eCollection 2024 Jan.

Abstract

BACKGROUND

Physical and psychological interventions could affect the quality of life (QoL) of women with infertility. The purpose of this study was to compare the effectiveness of dry cupping and counselling with the mindfulness-based cognitive therapy (MBCT) approach on fertility QoL and conception success in infertile women due to polycystic ovary syndrome (PCOS).

METHODS

This was a two-arm pilot randomized clinical trial from first January 2021 to the end of November 2022. In this regard, 19 women with infertility who were referred to the health centers affiliated with Shiraz University of Medical Sciences and met the inclusion criteria were enrolled in the study. Participants were randomly divided into two groups (10 in the virtual MBCT group and 9 in the cupping group). All participants completed the fertility quality of life (FertiQol) tool before the intervention and three months after the end of the intervention. In addition, after the end of the intervention, a human chorionic gonadotropin test was performed monthly for three months, too. We used ANOVA/ANCOVA and its related effect sizes, including mean difference (MD) and standard mean difference (SMD: Hedges's g), and chi-square tests to compare the study group outcomes in Stata 14.2. P-values equal to or less than 0.10 were considered significant.

RESULTS

The intervention resulted in significant differences in the mean overall scores of FertiQol between the counseling and cupping groups (61.76±14.28 and 50.65±12.53, respectively) [P=0.091, MD=11.11 (90% CI: 0.33 to 21.89), SMD=1.07 (90% CI: 0.279 to 1.84)]. No significant difference was found in conception rates between the groups after the intervention.

CONCLUSION

This pilot study found that MBCT improved the fertility QoL in PCOS-related infertility patients better than cupping therapy.

TRIAL REGISTRATION

IRCT201706110334452N1.

摘要

背景

身体和心理干预措施可能会影响不孕女性的生活质量(QoL)。本研究的目的是比较干拔罐和咨询与基于正念认知疗法(MBCT)对多囊卵巢综合征(PCOS)所致不孕女性生育 QoL 和受孕成功率的影响。

方法

这是一项从 2021 年 1 月 1 日至 2022 年 11 月结束的双臂前瞻性随机临床试验。在这方面,将 19 名因多囊卵巢综合征而被转诊到 Shiraz 大学医学科学附属健康中心并符合纳入标准的不孕女性纳入研究。参与者被随机分为两组(虚拟 MBCT 组 10 人,拔罐组 9 人)。所有参与者在干预前和干预结束后三个月完成生育质量生活(FertiQol)工具。此外,干预结束后,每月进行一次人绒毛膜促性腺激素测试,共三个月。我们使用 ANOVA/ANCOVA 及其相关效应量,包括均数差(MD)和标准均数差(SMD:Hedges 的 g),以及卡方检验来比较 Stata 14.2 中的研究组结果。P 值等于或小于 0.10 被认为具有统计学意义。

结果

干预导致咨询和拔罐组之间 FertiQol 总分的均值有显著差异(分别为 61.76±14.28 和 50.65±12.53)[P=0.091,MD=11.11(90% CI:0.33 至 21.89),SMD=1.07(90% CI:0.279 至 1.84)]。干预后两组的受孕率无显著差异。

结论

这项初步研究发现,MBCT 改善了多囊卵巢综合征相关不孕患者的生育 QoL,优于拔罐疗法。

试验注册

IRCT201706110334452N1。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/79bf/10844878/c57707765895/IJCBNM-12-57-g001.jpg

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