Genitourinary syndrome of menopause (GSM) is a prevalent condition among breast cancer survivors, often exacerbated by oncological treatments. Hormonal therapies are typically contraindicated in this population, necessitating effective non-hormonal interventions.

This randomised controlled trial aims to compare the effectiveness and cost-effectiveness of multimodal pelvic floor physiotherapy—comprising pelvic floor muscle training, non-ablative radiofrequency, therapeutic pelvic health education and the use of vaginal moisturisers—versus fractional CO₂ laser therapy combined with vaginal moisturisers in alleviating GSM symptoms in breast cancer survivors. Participants will be randomly assigned to one of the two intervention groups. Primary outcomes include measures of sexual function (assessed by the Female Sexual Function Index), subjective pelvic perineal pain intensity (measured with a 100 mm Visual Analogue Scale) and health-related quality of life (assessed by the Functional Assessment of Cancer Therapy-Breast), assessed at baseline, post-intervention and at 3, 6 and 12 months of follow-up. Statistical analyses will be conducted to evaluate the clinical efficacy and cost-effectiveness of the interventions.

The study protocol has been approved by the Ethics and Health Research Committee of the University of Alcalá (Reference: CEIP/2024/1/012). All participants will provide informed consent prior to inclusion in the study. Findings will be disseminated through peer-reviewed journals and conference presentations, and by engaging with patient associations and survivor groups through tailored materials.

NCT06721936.

Emerging adulthood is a new life stage characterised by identity exploration, instability, self-focus, a feeling of ‘being in-between’ and the perception of a range of possibilities. Emerging adults may experience difficulties in their well-being during this complex stage. Adaptive emotion regulation can improve levels of well-being. Previous studies have shown that new technologies can enhance social-emotional competencies in this population. The purpose of the study is to design and implement a serious game, emoWELL, which improves knowledge and the use of adaptive skills of emotion regulation to improve well-being during emerging adulthood.

The participants will be 385 emerging adults aged 18–29 years. They will be randomly assigned to either the control or experimental group. The experimental group will complete the emoWELL serious game. The game takes place on a train ride with several stops where the player will learn about emotion regulation. To assess the effectiveness of emoWELL, psychological assessment instruments validated in the Spanish population will be used. The primary expected outcomes include characteristics of emerging adulthood, emotion regulation (emotion dysregulation, emotion regulation strategies and cognitive reappraisal and expressive suppression) and psychological well-being. The secondary expected outcomes are self-esteem, psychological distress, loneliness and optimism. The assessment will occur at two different time points: pretest (T1) and post-test (T2) to observe improvements in the variables of interest.

The study has been approved by the Ethics Committee of the Universitat de València (2013883) and will follow the standards of the Declaration of Helsinki for data collection. The findings will be shared with the scientific community. The intellectual property registration number is as follows: UV-SW-202460R.

NCT06049407.