Effects of digital health education intervention on stress, anxiety and depression of patients with polycystic ovarian syndrome: study protocol for a single blinded randomized controlled trial.

BACKGROUND: Polycystic ovarian syndrome (PCOS) is an endocrine disorder that is connected to a range of gynecological symptoms. The disorder has both physical and mental health outcomes. While the physical symptoms are often expressed and diagnosed, the mental health outcomes are ignored and undiagnosed. To the best of our knowledge, in Bangladesh, although women are affected by the disease, research exploring the impact of digital health interventions on the mental health burden is scarce. Emerging evidence suggests that smartphone-based health education interventions could be helpful in alleviating the psychological burden associated with PCOS by improving awareness and self-management among patients. OBJECTIVE: The aim of the study is to explore the impact of digital health education on the stress, anxiety, and depression levels among PCOS patients in Bangladesh. METHODS: A single blinded, randomized controlled trial was being conducted at the Enayetpur of Sirajganj district at Khwaja Yunus Ali Medical College and Hospital. A total of 212 participants were randomly assigned to either the intervention group or the control group in the study. The intervention group received PCOS related health education via a mobile application reinforced with app notifications and bi-monthly phone calls from the researcher. Baseline Data collection was completed in April 2025. Endline data collection started in November 2025. The intervention was a six-month intervention that ran from May to October. The primary outcome, depression, stress and anxiety was measured using the DASS21 questionnaire. The secondary outcomes were serum hormone levels (cortisol and testosterone), body mass index (BMI), and knowledge about PCOS. RESULTS: The baseline data collection was completed in April 2025. A total of 212 patient provided their consent to participate in the study. The participants were divided into groups of 106 individuals for the control and intervention groups. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT2062240073), https://jrct.mhlw.go.jp/en-latest-detail/jRCT2062240073 and North South University Institutional Review Board approved this study (#2024/0RNSU/IRBII 002).