Nieves-Vázquez Cristina I, Detrés-Marquéz Amanda C, Torres-Reverón Annelyn, Appleyard Caroline B, Llorens-De Jesús Astrid P, Resto Ivana N, López-Rodríguez Verónica, Ramos-Echevarría Paola M, Castro Eida M, Flores Idhaliz
Public Health Program, Ponce Health Sciences University, Ponce, Puerto Rico.
School of Medicine, Ponce Health Sciences University, Ponce, Puerto Rico.
Front Glob Womens Health. 2023 Jan 4;3:1058559. doi: 10.3389/fgwh.2022.1058559. eCollection 2022.
We have previously shown that Environmental Enrichment (EE)-consisting of social support, novelty, and open spaces-decreased disease progression and anxiety in a rat model of endometriosis. We developed a novel EE intervention to be tested in a pilot randomized clinical trial (RCT) in patients with endometriosis, a painful, stressful disease.
To translate and evaluate the feasibility and acceptability of an adapted EE intervention as an adjuvant to standard-of-care for endometriosis patients.
Feasibility was assessed through recruitment, enrollment, and adherence rates. Acceptability was evaluated through a post-intervention survey and focus group discussion 3-months after the end of the intervention.
Of the 103 subjects recruited, 64 were randomized to the intervention group and 39 to the control group. At the start of the intervention, the study groups consisted of 29 (intervention) and 27 (control) subjects. Enrollment rates were 45.3% and 69.2%, and adherence rates were 41.4% and 100% for the intervention and control groups, respectively. Delays resulting from natural events (earthquakes, the COVID-19 pandemic) impacted enrollment and adherence rates. The most common reasons for missing an intervention were period pain (39.1%) and work-study (34.8%). There was high acceptability (>80%) of the intervention's logistics. The majority (82.4%) of subjects would continue participating in support groups regularly, and 95.7% would recommend the intervention to other patients.
We showed that EE could be translated into an acceptable integrative multi-modal therapy perceived as valuable among participants who completed the intervention. High attrition/low adherence indicates that additional refinements would be needed to improve feasibility. Acceptability data indicate that EE has the potential to be integrated into the clinical management of patients with endometriosis and other inflammatory, painful disorders. Studies are ongoing to assess the efficacy of EE in improving pain symptoms, mental health, and quality of life (QoL).
我们之前已经表明，环境富集（EE）——包括社会支持、新奇事物和开放空间——可减缓子宫内膜异位症大鼠模型的疾病进展并减轻焦虑。我们开发了一种新型的EE干预措施，将在一项针对子宫内膜异位症患者的试点随机临床试验（RCT）中进行测试，子宫内膜异位症是一种痛苦且压力大的疾病。
将一种改良的EE干预措施作为子宫内膜异位症患者标准治疗的辅助手段进行翻译，并评估其可行性和可接受性。
通过招募率、入组率和依从率评估可行性。在干预结束3个月后，通过干预后调查和焦点小组讨论评估可接受性。
在招募的103名受试者中，64名被随机分配到干预组，39名被分配到对照组。在干预开始时，研究组分别由29名（干预组）和27名（对照组）受试者组成。干预组和对照组的入组率分别为45.3%和69.2%，依从率分别为41.4%和100%。自然事件（地震、新冠疫情）导致的延误影响了入组率和依从率。错过干预的最常见原因是经期疼痛（39.1%）和学习工作（34.8%）。干预措施的后勤安排具有较高的可接受性（>80%）。大多数受试者（82.4%）会继续定期参加支持小组，95.7%的受试者会向其他患者推荐该干预措施。
我们表明，EE可以转化为一种可接受的综合多模式疗法，在完成干预的参与者中被认为是有价值的。高损耗率/低依从率表明需要进一步改进以提高可行性。可接受性数据表明，EE有潜力被纳入子宫内膜异位症及其他炎症性疼痛疾病患者的临床管理中。正在进行研究以评估EE在改善疼痛症状、心理健康和生活质量（QoL）方面的疗效。
