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

Sadia Akter; Farkhanda Mahjebin; Mohammad Delwer Hossain Hawlader; Md Moshiur Rahman; Sanmei Chen; Saori Kashima; Sheuly Akter; Shamit Dasgupta; Yoko Shimpuku; Sadia Akter; Farkhanda Mahjebin; Mohammad Delwer Hossain Hawlader; Md Moshiur Rahman; Sanmei Chen; Saori Kashima; Sheuly Akter; Shamit Dasgupta; Yoko Shimpuku

doi:10.3934/publichealth.2026007

AIMS Public Health

2026, Volume 13, Issue 1: 105-120. doi: 10.3934/publichealth.2026007

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Protocol Topical Sections

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

1.
Graduate School of Innovation and Practice for Smart Society, Hiroshima University, Japan
2.
Khwaja Yunus Ali Medical College and Hospital, Bangladesh
3.
Department of Public Health, North South University, Bangladesh
4.
NSU Global Health Institute (NGHI), North South University, Dhaka 1229, Bangladesh
5.
Graduate School of Biomedical and Health Sciences, Hiroshima University, Japan
6.
Center for the Planetary Health and Innovation Science, The IDEC Institute, Hiroshima University, Japan
7.
Environmental Health Sciences Laboratory, Graduate School of Advanced Science and Engineering, Hiroshima University, Japan
8.
Ministry of Health, Government of British Columbia, Canada

Received: 17 August 2025 Revised: 31 October 2025 Accepted: 13 November 2025 Published: 09 January 2026

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).
- polycystic ovarian syndrome,
- depression,
- anxiety,
- stress,
- mHealth,
- digital health education
Citation: Sadia Akter, Farkhanda Mahjebin, Mohammad Delwer Hossain Hawlader, Md Moshiur Rahman, Sanmei Chen, Saori Kashima, Sheuly Akter, Shamit Dasgupta, Yoko Shimpuku. 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[J]. AIMS Public Health, 2026, 13(1): 105-120. doi: 10.3934/publichealth.2026007

Related Papers:

Abstract

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).

Acknowledgments

We extend our sincere appreciation to all participating patients for their cooperation. The authors are deeply grateful to the gynecologist, research assistants, hospital staff and laboratory employees for their unwavering help and support. The lead researcher also acknowledges Khawaja Yunus Ali Medical College and hospital and Hiroshima University for their ongoing institutional and infrastructural support.
The study secured its funding from the Satake Memorial Fund and the SMASO-X Challenge Researcher Grant. Authors were not involved in funding body and any other funding authority for this study. Funding body authority had no role in design of the study, analysis or reporting of trial.
The trial is monitored by the principal investigator and all the co-authors of the paper. The principal investigator routinely checked and ensured data collection.

Authors' contributions

SA, YS, MR, SC, SK, SD together designed the study. FM, SA performed the field monitoring, regulatory approval, ensured data accurately submission, helped with protocol design finalization providing realistic field scenario. DH helped with ethical considerations and regulatory approval. SC YS contributed to statistical planning and sample size calculation. All authors reviewed and approved the final version of the protocol.

Conflict of interest

The authors declare no conflict of interest.

References

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