What is the Impact of an E-tool Based Mindfulness Intervention on Psychological Outcomes Compared to no Intervention in Infertile Women Undergoing Assisted Reproductive Technique Treatments: A Randomized Controlled Study?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in anxiety state scores
研究概览
简要总结
Infertility and its treatments can have a significant impact on women's psychological health. Anxiety has a negative impact on quality of life during treatment and can lead to withdrawal of care. the investigators would like to test the effectiveness of an application available via the Internet that offers daily exercises such as mindfulness meditation. Women in the "treatment" group will be instructed to practice meditation exercises using the 15-minute daily application during in vitro fertilization treatment until pregnancy testing. Women in the control group will have the standard care of the centre. The investigators will measure the effectiveness of the intervention on anxiety, depression, quality of life and mindfulness aspects. The investigators will also assess the impact on the chances of pregnancy and stress.
详细描述
Infertility is an unexpected and stressful life with emotional, social and sexual repercussions. Women undergoing assisted reproductive techniques (ART) exhibit high anxiety and/or depression scores during the pre-treatment period, during the course of treatment and during the 2 weeks waiting-time for the pregnancy test.
The impact of psychological distress on ART outcomes is debated. Several studies report a negative impact of stress on pregnancy rates after IVF whereas two meta-analyses report inconclusive results regarding the association between emotional distress and pregnancy outcomes after ART.
The success rates of ART, which are highly dependent on the woman's age, are low in women in their late reproductive years with the need of several ART treatments to achieve pregnancy. Moreover, ART is often the last resort treatment in couples that have undergone infertility investigations and other first-line treatments such as surgery, ovulation induction and/or stimulation with intra-uterine insemination. Couple need resilience in order to undergo repeated treatments. Psychological distress therefore has an impact on cumulative pregnancy rates over several ART treatments because of premature treatment discontinuation. Depressive symptoms at baseline have been shown to predict treatment "dropout" after only one cycle.
Preliminary evidence suggests that mind-body interventions, including mindfulness-based interventions and yoga, may be effective in reducing mental health difficulties such as anxiety and depression in infertile women undergoing treatments.
The aim of the investigators was to develop a psychological self-help tool using modern technological means in line with the recent Femtech (female technology) developments. The hypothesis was that an online meditation tool would be more accessible and easier to integrate into a busy schedule than standard programs that require weekly attendance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants fulfilling all of the following inclusion criteria are eligible for the study:
- •French-speaking
- •Women between the ages of 18-42 years
- •Scheduled for the first IVF treatment in HUG/CHUV/CPMA Lausanne
- •Access to a computer/smartphone/tablet with access to internet and a valid Email address
- •Informed Consent as documented by her signature on the form (Appendix Informed Consent Form)
排除标准
- •Psychotropic medication
- •Ongoing psychiatric/psychological treatment
- •Known severe psychiatric co-morbidity
结局指标
主要结局
Change in anxiety state scores
时间窗: 1 month
The primary aim of the study is to evaluate the effect of an e-tool based intervention versus standard care without intervention on anxiety state measured by the French version of state trait anxiety index in infertile women undergoing ART. State trait anxiety index state scores will be evaluated by completion of a questionnaire at 3 time points: baseline, at the time of the oocyte retrieval, on the day before the pregnancy test (before the results). A score between 31 and 36 is considered as normal score.
次要结局
未报告次要终点
研究者
Isabelle Streuli
Principal investigator
University Hospital, Geneva