Journal Article

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

Mikaeil, Arefeh, Shafizadeh, Fatemeh, Bijani, Ali, Nasiri-Amiri, Fatemeh, Hamzehpour, Romina, Behmanesh, Fereshteh, Delavar, Mouloud Agajani, Afshar, Zeinab Mohseni

2026

Overview

IntroductionHuman 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 analysisThis 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 disseminationThis 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 numberIRCT20180218038783N11, 14 September 2025.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adult / Anxiety / Cervical cancer / Clinical Trial / Clinical trials / Counseling / Counseling - methods / Female / Health / HPV Infection / Human papillomavirus / Human Papillomavirus Viruses / Humans / Immunization / Infections / Intervention / Iran / Medical diagnosis / Medical personnel / Medical research / Medical screening / Mental disorders / Mental health / Obstetrics and Gynaecology / Oncology / Pap smear / Papillomavirus Infections - psychology / Papillomavirus Infections - therapy / Protocol / Quality of Life / Randomized Controlled Trials as Topic / Research Design / Surveys and Questionnaires / Warts / Womens health / Young Adult