Treatment for women with endometriosis is only partially or temporarily effective. Moreover, medical hormonal treatment is associated with debilitating side effects and interferes with fertility, while surgery has a relatively high risk of complications. Meanwhile, women with endometriosis show increasing interest in implementing lifestyle interventions to alleviate symptoms and improve health-related quality of life (HRQoL). Integrating these lifestyle interventions can provide a holistic approach to the treatment of this debilitating disease. However, scientific evidence supporting the effectiveness of these interventions is limited. This study is designed to investigate the effectiveness of two lifestyle interventions and the combination of both: an anti-inflammatory diet intervention (AIDI) could improve immune cell function and reduce inflammation, resulting in improved HRQoL and alleviating pain. In addition, the integration of cognitive behavioural therapy (CBT) aims to provide insight into pain mechanisms and coping with pain, and to assist in sustaining dietary adjustments.

The Pain in Endometriosis And the Relation to Lifestyle (PEARL) study is a five-arm randomised controlled trial with a pre-post factorial design with two factors: an AIDI and CBT. The study population will consist of 250 premenopausal women, of whom 200 are diagnosed with endometriosis and experience pain symptoms and 50 are healthy controls (HC). Women with endometriosis will be recruited from one academic tertiary and five secondary hospitals in the Netherlands. They will be randomised (1:1:1:1) among four intervention groups: standard care (SC) (SC group), SC and an AIDI (SC + AIDI group), SC and CBT (SC + CBT group), and SC, AIDI and CBT (SC + AIDI + CBT group). Women with endometriosis will visit the hospital twice during the intervention period, at the start (T0) and end (T2) of the 13-week intervention period. HC will not undergo any of the interventions and will have one hospital visit (T0). Participants will complete questionnaires regarding pain symptoms, HRQoL, physical activity level, sleep, diet quality, pain cognitions, and stress at T0 and T2. Furthermore, they are instructed to collect menstrual effluent, a vaginal swab and a faecal sample. During the study visits, peripheral blood will be drawn and scalp hair samples will be taken. The primary outcome is average pain, measured using a numerical rating scale. Secondary outcomes focus on HRQoL, inflammation, immune system characteristics, vaginal- and gut microbiome, and hair cortisol levels. These are considered to reflect potentially underlying mechanisms of the effect of both interventions on the primary outcome. Biological samples and questionnaires of women with endometriosis and HC will be compared to establish the differences in secondary outcomes.

This study protocol has been approved (approval number: NL86247.091.24) by the METC Oost-Nederland from Radboud University Medical Centre on July 11, 2024. Prior to participation, participants are required to provide informed consent. The results will be widely disseminated through scientific peer-reviewed journals, and presentation to a broad audience in scientific meetings, congresses, patient meetings, as well as in policy-relevant forums.

NCT06332560.

Squamous cell carcinoma and multiple actinic keratoses caused by solar ultraviolet radiation (UVR) are among the most frequently recognised occupational diseases in Germany. Employees who regularly work outdoors, for example, in the construction industry, agriculture, forestry and gardening, are at a higher risk of developing occupational skin cancer. However, sun-safety behaviour in outdoor workers is currently insufficient. Therefore, this study aims to investigate the effectiveness of an intervention to increase sunscreen use among outdoor workers.

In this non-randomised, controlled intervention study, 234 outdoor workers from different companies in industries with outdoor working activities based in Germany will be included. The study population, aged 18 years and above, has to be intensively exposed to solar UVR of regularly 1 hour or more per day. The intervention group will receive a sunscreen package as well as health education. The control group follows the practice in their companies (‘treatment-as-usual’). At the beginning of the study, after 3 months and at the end of the study (after 6 months), both groups filled in different questionnaires. In addition, stratum corneum (SC) samples will be collected at the beginning and after 3 months. The primary outcome—increase in the frequency of sunscreen use during work and in leisure time—will be assessed from data on self-reported sunscreen use. The secondary outcomes include sun protection behaviour, knowledge about sun protection and skin cancer, and acceptance of the provided sunscreens. Further secondary outcomes include internal UV dose and UV-related immune response, determined by the levels of SC biomarkers. Data will be analysed using both descriptive and inferential methods.

The study protocol followed the principles of the Declaration of Helsinki (2013) and was approved by the Ethics Committee of Osnabrück University, Germany (reference Ethik-37/2024). Study results will be disseminated through peer-reviewed publications and conference presentations.

DRKS00035178.

Body contouring surgery (BCS) can be applied to reduce the physical and mental burden of excess skin after massive weight loss. Self-reported outcomes of patients are used to assess this burden and to evaluate the effectiveness of BCS. The aim of this study is to clarify what is reflected in self-reports of excess skin after bariatric surgery. We hypothesise that the self-reported burden of excess skin is associated with both objectively assessed excess skin and the disposition to experience negative emotions.

This cross-sectional study will include 68 outpatients presenting at a plastic surgery clinic with a request for BCS. Patients fill out two questionnaires (the BODY-Q and the Sahlgrenska Excess Skin Questionnaire (SESQ)) to measure the size and burden of excess skin as well as the Big Five Inventory (BFI) to measure the disposition towards negative emotionality. Anonymised photographs of excess skin will be rated independently by four plastic surgeons using the Pittsburgh Rating Scale (PRS) Rainbow Classification to establish the objective amount of excess skin. Multiple linear regression analyses will be performed to identify the association of BODY-Q and SESQ scores with objective appraisals of excess skin by plastic surgeons, negative emotionality and demographics. Interobserver agreement for PRS Rainbow Classification will be established by Fleiss’ kappa.

Ethical approval was obtained from the regional medical ethics committee (METC; W20.258) and the institutional review board (Lokale Toetsing, St. Antonius Hospital in Nieuwegein, no. Z23.035). Informed consent of participants will be obtained. The results of this study will be submitted for publication in a peer-reviewed journal.