Hypothesis / aims of study
Genito-Pelvic Pain/Penetration Disorder (GPPPD) poses a significant challenge in clinical practice due to its complex etiology and the limited efficacy of traditional treatment approaches. The hypothesis of this study was that therapeutic education, encompassing pain management strategies, anatomical education, and sexual self-awareness, would effectively alleviate pain and improve sexual function among women suffering from GPPPD. Additionally, the study aimed to investigate whether the delivery method of educational interventions, either in-person or online, influenced treatment outcomes.
Study design, materials and methods
This randomized controlled trial adhered to the CONSORT guidelines and ethical principles outlined in the Declaration of Helsinki. Recruitment of participants took place between December 2021 and February 2022 from hospital databases and social media platforms. Eligible participants, diagnosed with GPPPD by a gynecologist, underwent screening via an online form. Baseline and post-intervention assessments were conducted using validated scales and questionnaires, including the Visual Analogue Scale (VAS) for pain intensity, the Pain Catastrophizing Scale (PCS), the Brief version of the Survey of Pain Attitudes (SOPA-B), and the Female Sexual Function Index (FSFI).
The therapeutic educational program, designed to provide comprehensive education on GPPPD management, was delivered in two parallel intervention groups: in-person and online. A control group received no intervention initially but was granted access to the online educational program post-assessment. Randomization was achieved using the opaque envelope method, with participants allocated in a 2:1 ratio. Statistical analysis involved a two-way mixed ANOVA to assess changes over time and between-group comparison testing using the Bonferroni post-hoc test. Sample size was calculated using the GPower software. Calculations were based on a study that assessed pain intensity through the VAS in a similar population. To achieve sufficient statistical power of 80% with an alpha-error of 0.05, and accounting for possible dropouts, the sample would contain at least 69 participants overall and 23 participants at least in every group.
Results
A total of 69 participants were enrolled and randomly allocated to the in-person group (n=18), online group (n=29), and control group (n=22). Significant improvements in pain intensity were observed in both the in-person and online intervention groups. Specifically, the mean difference (MD) in pain intensity, as measured by the VAS, was 1.4 (SD 1.9, CI 95% 0.4-2.4) in the in-person group and 0.9 (SD 1.9, CI 95% 0.2-1.7) in the online group. Pain catastrophizing also showed significant reductions in the online group, with an MD of 7.6 (SD 8.6, CI 95% 4.2-11.0). However, no significant changes were observed in sexual function across all groups.
Interpretation of results
The findings underscore the efficacy of therapeutic education in alleviating pain intensity among women with GPPPD, regardless of the delivery modality. The online format offers a discreet platform for addressing sensitive issues related to sexual health, potentially overcoming barriers associated with in-person therapy. However, the lack of significant improvements in sexual function highlights the need for tailored interventions focusing on sexual behavior to address the multifaceted challenges associated with GPPPD effectively.