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IRCT20201113049377N4 IRCT 2026-03-19 Zanjan University of Medical Sciences The Effect of Counseling on the Sexual Quality of Life of Women with Human Papillomavirus Infection The Effect of Acceptance and Commitment Therapy (ACT) on the Sexual Quality of Life in Women Infected with Human Papillomavirus (HPV) 2026-04-03 anticipated 48 Recruiting https://irct.ir/trial/89265 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After providing a comprehensive explanation of the study objectives and procedures to eligible clients, women who meet the inclusion criteria will be identified. Subsequently, the demographic information questionnaire and the Sexual Quality of Life questionnaire will be administered for completion. Eligible participants will be recruited during their routine and consecutive visits to the gynecology clinic. They will then be randomly allocated into intervention and control groups using block randomization method (block size: four). For this purpose, 12 blocks of four participants each will be generated using a table of random numbers, resulting in a total sample size of 48 participants. The block randomization process will be carried out by an individual who is not involved in the sampling or intervention procedures to minimize allocation bias. The generated random sequences will be recorded on individual cards and placed sequentially into sealed envelopes. After sealing, the envelopes will be stored in a box. At the initiation of the intervention, envelopes will be opened sequentially, and the participant’s group assignment will be determined accordingly. N/A Women Infected with Human Papillomavirus. Intervention 1: Intervention group: Participants in this group will receive counseling based on Acceptance and Commitment Therapy (ACT). The intervention consists of eight weekly 90‑minute group sessions conducted by a trained researcher. The session content includes introduction to the principles and concepts of the ACT approach, reduction of experiential avoidance, acceptance of negative emotions (such as shame and anxiety), mindfulness exercises, identification of personal values in the domains of health and intimate relationships, and planning for committed actions aimed at improving sexual functioning and sexual experience. Intervention 2: Control group:Participants in this group will not receive any ACT‑based educational or counseling intervention during the study period and will only receive routine care. To observe ethical considerations, after completion of the study an educational booklet containing the session content will be provided to participants in the control group, and if desired, an educational session will be held for them. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Parvin Mohebbi
Department of Midwifery,School of Nursing and Midwifery,Haj Ahmad Mahdavi Blvd,Shahrak Karmandan Zanjan
Zanjan Iran (Islamic Republic of) 4513956113 +98 24 3346 9500 p.mohebbi11@gmail.com Zanjan University of Medical Sciences scientific Parvin Mohebbi
Department of Midwifery,School of Nursing and Midwifery,Haj Ahmad Mahdavi Blvd,Shahrak Karmandan Zanjan
Zanjan Iran (Islamic Republic of) 4513956113 +98 24 3346 9500 p.mohebbi11@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Ability to read and write (minimum literacy level) Women aged 18–45 years (to reduce the potential impact of age-related changes on sexual function). Women who are married and sexually active Laboratory-confirmed positive test for Human Papillomavirus (HPV) At least six months since the initiation of marital life Poor to moderate sexual quality of life based on the Sexual Quality of Life–Female (SQOL-F) questionnaire 18 years 45 years Female Occurrence of stressful life events within the past 6 months History of psychological disorders or underlying medical conditions Substance or alcohol abuse Lifestyle Lifestyle Intervention group: Participants in this group will receive counseling based on Acceptance and Commitment Therapy (ACT). The intervention consists of eight weekly 90‑minute group sessions conducted by a trained researcher. The session content includes introduction to the principles and concepts of the ACT approach, reduction of experiential avoidance, acceptance of negative emotions (such as shame and anxiety), mindfulness exercises, identification of personal values in the domains of health and intimate relationships, and planning for committed actions aimed at improving sexual functioning and sexual experience. Control group:Participants in this group will not receive any ACT‑based educational or counseling intervention during the study period and will only receive routine care. To observe ethical considerations, after completion of the study an educational booklet containing the session content will be provided to participants in the control group, and if desired, an educational session will be held for them. Quality of Sexual Life. Timepoint: Before, immediately and one month after the intervention. Method of measurement: Sexual Quality of Life–Female Questionnaire (SQOL‑F) by Symonds. Zanjan University of Medical Sciences Approved 2026-02-03 Ethics Committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Professor Dr. Yousef Sobhouti Boulevard, Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)