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. 2023 Jan 4:3:1058559.
doi: 10.3389/fgwh.2022.1058559. eCollection 2022.

Feasibility and acceptability of an adapted environmental enrichment intervention for endometriosis: A pilot study

Cristina I Nieves-Vázquez  1 , Amanda C Detrés-Marquéz  2 , Annelyn Torres-Reverón  3   4 , Caroline B Appleyard  2   3   4 , Astrid P Llorens-De Jesús  2 , Ivana N Resto  2 , Verónica López-Rodríguez  5 , Paola M Ramos-Echevarría  5 , Eida M Castro  5 , Idhaliz Flores  2   3   4   6
Affiliations

Feasibility and acceptability of an adapted environmental enrichment intervention for endometriosis: A pilot study

Cristina I Nieves-Vázquez et al. Front Glob Womens Health. .

Abstract

Introduction: 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.

Objective: To translate and evaluate the feasibility and acceptability of an adapted EE intervention as an adjuvant to standard-of-care for endometriosis patients.

Methods: 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.

Results: 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.

Conclusions: 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).

Keywords: acceptability; endometriosis; environmental enrichment; feasibility; psychosocial; randomized clinical trial.

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Conflict of interest statement

ATR, CBA, IF are co-founders of Sur180 Therapeutics, LLC. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Translation of the EE paradigm to humans. A multidisciplinary team of experts, with input from a patient advisory committee, translated an enriched environment intervention based on the EE paradigm consisting of social support, novelty, and open spaces to be tested in a pilot psychosocial trial. EE interventions took place in open space venues (e.g., beach, lake, garden, hot springs, countryside) and consisted of a support group meeting (1 ½ h) and a novel stress-management activity (1 h). The interventions were conducted every other Saturday morning for a period of 6 months.
Figure 2
Figure 2
Enrollment diagram. The recruitment, enrollment, and retention of the EE pilot RCT are shown. Recruitment was conducted via social media of a patient support foundation. There were two recruitment efforts for Session I which took place from August to October 2021, and one for Session II which took place February to April 2022. A total of 118 individuals were screened and 103 were randomized to the EE vs. control groups. Final enrollment was n = 29 (EE) and n = 27 (control). Dropout rates were 54.7% for the EE group and 30.8% for the control group.
Figure 3
Figure 3
Participation rate of study subjects in the EE intervention. Full dose and half dose are shown in panel A. Reasons for missing an intervention were documented via an online survey are shown in panel B.
Figure 4
Figure 4
Intervention evaluation survey results are shown. Favorite modules are shown in panel A. Favorite venues are shown in panel B. Acceptability of logistics are shown in panel C.
Figure 5
Figure 5
Word clouds representing the most common words used to describe the subjects’ experience during the EE intervention. Transcripts from support group discussion that took place 3 months after the end of the intervention were analyzed using NVivo. Perceived benefits of the EE intervention are shown in panel A. Perceived value of the EE intervention for the management of endometriosis symptoms is shown in panel B.
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