评估冥想是否能改善多囊卵巢综合征少女的生活质量：一项随机对照试验方案
Assessing Whether Meditation Improves Quality of Life for Adolescent Girls With Polycystic Ovary Syndrome: Protocol for a Randomized Controlled Trial.
作者信息
Hewawasam Erandi, Brennan Leah, Giles Lynne, Hull Mary Louise, Short Asha, Norman Robert, Peña Alexia S
机构信息
Discipline of Paediatrics, Robinson Research Institute, University of Adelaide, Adelaide, Australia.
Department of Endocrinology and Diabetes, Women's and Children's Hospital, North Adelaide, Australia.
出版信息
JMIR Res Protoc. 2020 Jan 28;9(1):e14542. doi: 10.2196/14542.
BACKGROUND
Polycystic Ovary Syndrome (PCOS) is a common endocrine condition characterized by irregular periods and hyperandrogenism. Adolescents with PCOS have impaired quality of life (QOL) and increased psychological distress. Transcendental Meditation (TM) is a well-established self-management strategy that has been used to improve stress and well-being. A meta-analysis of TM trials has shown beneficial effects on stress and blood pressure in adults. Recent data are suggesting that another self-management strategy called a mindfulness stress management program has a role in improving QOL in women with PCOS, but there are no studies in adolescents.
OBJECTIVE
This study aims to evaluate the effect of TM on QOL and psychological distress in adolescent girls with PCOS.
METHODS
This study is a randomized controlled trial that will be conducted over eight weeks at the Women's and Children's Hospital in Adelaide, South Australia, to determine the effect of TM on QOL and psychological distress in adolescent girls (aged 12-20 years) with PCOS. A total of 40 girls will be randomized into either the TM (n=20) or control group (n=20). The TM group will be asked to practice TM in a comfortable sitting position with the eyes closed, for 15 minutes twice daily over eight weeks. The control group will be asked to sit quietly for 15 minutes twice daily for eight weeks. The primary outcomes are any effects on improving QOL and psychological distress, and the secondary outcomes are any effects on lowering blood pressure and salivary cortisol levels.
RESULTS
The recruitment of study participants began in May 2019 and is expected to be completed by June 2020. It is expected that the adolescent girls with PCOS practicing TM over eight weeks will have a significant improvement in QOL and psychological distress compared to adolescents in the control group. Also, it is expected that adolescent girls in the TM group will have lower salivary cortisol levels and lower blood pressure.
CONCLUSIONS
This study will be the first to evaluate the effect of TM on QOL in adolescent girls with PCOS. The study will provide valuable information on a potential self-management strategy to improve QOL and well-being in adolescent girls with PCOS.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN1261900019010; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376657&isReview=true.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/14542.
背景
多囊卵巢综合征（PCOS）是一种常见的内分泌疾病，其特征为月经不规律和雄激素过多。患有PCOS的青少年生活质量（QOL）受损，心理困扰增加。超觉静坐（TM）是一种成熟的自我管理策略，已被用于改善压力和幸福感。一项对TM试验的荟萃分析显示，其对成年人的压力和血压有有益影响。最近的数据表明，另一种称为正念压力管理计划的自我管理策略在改善PCOS女性的生活质量方面发挥了作用，但尚无针对青少年的研究。
目的
本研究旨在评估TM对患有PCOS的青春期女孩生活质量和心理困扰的影响。
方法
本研究是一项随机对照试验，将在南澳大利亚阿德莱德妇女儿童医院进行为期八周的研究，以确定TM对患有PCOS的青春期女孩（12 - 20岁）生活质量和心理困扰的影响。总共40名女孩将被随机分为TM组（n = 20）或对照组（n = 20）。TM组将被要求在舒适的坐姿下闭上眼睛练习TM，每天两次，每次15分钟，持续八周。对照组将被要求每天安静地坐15分钟，持续八周。主要结局是对改善生活质量和心理困扰的任何影响，次要结局是对降低血压和唾液皮质醇水平的任何影响。
结果
研究参与者的招募于2019年5月开始，预计于2020年6月完成。预计与对照组的青少年相比，患有PCOS的青春期女孩在八周内练习TM将在生活质量和心理困扰方面有显著改善。此外，预计TM组的青春期女孩唾液皮质醇水平和血压会更低。
结论
本研究将是首个评估TM对患有PCOS的青春期女孩生活质量影响的研究。该研究将提供有关一种潜在的自我管理策略的有价值信息，以改善患有PCOS的青春期女孩的生活质量和幸福感。
试验注册
澳大利亚新西兰临床试验注册中心（ANZCTR）ACTRN1261900019010；https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376657&isReview=true。
国际注册报告识别码（IRRID）：PRR1 - 10.2196/14542。
Zotero 插件