BMJ open · 2026
Effectiveness of online supportive counselling on quality of life in women with high-risk human papillomavirus in Iran: study protocol for a randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Mikaeil Arefeh, Nasiri-Amiri Fatemeh, Shafizadeh Fatemeh, Behmanesh Fereshteh, Hamzehpour Romina, Bijani Ali, Delavar Mouloud Agajani, Afshar Zeinab Mohseni
Аннотация
INTRODUCTION: Human papillomavirus (HPV) is one of the most common sexually transmitted diseases and affects the quality of life (QoL) of individuals, necessitating interventions beyond physical treatments. The aim of this study is to determine the effectiveness of individual supportive counselling on the QoL in women with high-risk HPV.
METHODS AND ANALYSIS: This randomised clinical trial will include 80 women with HPV who will be selected from 2025 to 2026 in Babol, Iran. Following selection based on inclusion criteria, samples will be randomly allocated to intervention and control groups. Then, they will complete demographic-social questionnaires, QoL in HPV patients and general health questionnaires. Individuals in the intervention group will receive 4 weekly online supportive counselling sessions in addition to routine care. The control group will receive routine care. Both groups will complete the questionnaires again at 6 weeks and 4 months postbaseline. Data will be analysed using SPSS V.26 software and statistical tests including χ², t-test and repeated measures analysis of variance, and regression models if necessary. A significance level of 5% will be used for the tests.
ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.HRI.REC.1404.082). The trial will adhere to the ethical principles of the Declaration of Helsinki. Findings will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences.
TRIAL REGISTRATION NUMBER: IRCT20180218038783N11, 14 September 2025.
METHODS AND ANALYSIS: This randomised clinical trial will include 80 women with HPV who will be selected from 2025 to 2026 in Babol, Iran. Following selection based on inclusion criteria, samples will be randomly allocated to intervention and control groups. Then, they will complete demographic-social questionnaires, QoL in HPV patients and general health questionnaires. Individuals in the intervention group will receive 4 weekly online supportive counselling sessions in addition to routine care. The control group will receive routine care. Both groups will complete the questionnaires again at 6 weeks and 4 months postbaseline. Data will be analysed using SPSS V.26 software and statistical tests including χ², t-test and repeated measures analysis of variance, and regression models if necessary. A significance level of 5% will be used for the tests.
ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.HRI.REC.1404.082). The trial will adhere to the ethical principles of the Declaration of Helsinki. Findings will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences.
TRIAL REGISTRATION NUMBER: IRCT20180218038783N11, 14 September 2025.