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IRCT20111122008170N14 IRCT 2024-01-29 Tabriz University of Medical Sciences The effect of health promotion awareness counseling with stress management on anxiety and reproductive and sexual self-care performance in women with human papiloma virus The effect of health promotion awareness counseling with stress management on anxiety and reproductive and sexual self-care performance in women with human papiloma virus : a controlled clinical randomized trial 2024-02-12 anticipated 64 Complete https://irct.ir/trial/74823 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The women participating in the research will be assigned to two groups receiving counseling and the control group through 4 and 6 blocks with a ratio of 1:1 through 4 and 6 blocks using RAS software. The type of allocation will be written on paper and will be provided to the responsible author (the first guidance teacher) and the allocation of people to the intervention and control groups will be done by the same person in a central way (allocation concealment), Blinding description: The person analyzing the data will not be aware of the type of group assignment. N/A anxiety. Intervention 1: Intervention group: Intervention group: For the intervention group (32 people), six group counseling sessions (4-6 people) will be held for 60-90 minutes in one of the clinic rooms of Al-Zahra Hospital. In between the counseling sessions, the researcher will be in contact with the participants through telephone follow-ups so that they can participate in the counseling sessions on a regular basis. The researcher will provide his contact number to both intervention and control groups to answer the questions. The control group will receive routine care. If the positive effect of this approach in reducing anxiety and improving self-care performance in the intervention group is confirmed at the end of the study, counseling sessions will also be provided for the control group. The post-test questionnaires including Spielberger's anxiety, self-care and reproductive and sexual health literacy, and quality of life and stress will be completed by self-administered method. In case of incomplete participation in counseling sessions, the questionnaires will be completed and analyzed as Intention to Threat. Also, the missing cases will be investigated with the multiple imputation policy. Intervention 2: Control group: . The control group will receive routine care. If the positive effect of this approach in reducing anxiety and improving self-care performance in the intervention group is confirmed at the end of the study, counseling sessions will also be provided for the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public malakouti.jamileh
South Shariati Street, Faculty of Nursing and Midwifery
tabriz Iran (Islamic Republic of) 66156-15733 +98 41 3479 6770 jamilehmalakouti@yahoo.com Tabriz University of Medical Sciences scientific Malakouti.Jamileh
School of Nursing and Midwifery, South Shariati Street, Tabriz
tabriz Iran (Islamic Republic of) 66156-15733 +98 41 3479 6770 jamilehmalakouti@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Women with positive HPV test results and low-risk and high-risk groups Anxiety score 32-64 Having a contact number for follow-up Literacy for reading and writing 18 years no limit Female Cancer disease or its history History of participating in previous training and intervention programs related to sexual health and fertility intellectual disability Any mental illness according to the person's statement Any recent unfortunate incident including the loss of a loved one within the last 6 months F06.4 Anxiety disorder due to known physiological condition Other Other Intervention group: Intervention group: For the intervention group (32 people), six group counseling sessions (4-6 people) will be held for 60-90 minutes in one of the clinic rooms of Al-Zahra Hospital. In between the counseling sessions, the researcher will be in contact with the participants through telephone follow-ups so that they can participate in the counseling sessions on a regular basis. The researcher will provide his contact number to both intervention and control groups to answer the questions. The control group will receive routine care. If the positive effect of this approach in reducing anxiety and improving self-care performance in the intervention group is confirmed at the end of the study, counseling sessions will also be provided for the control group. The post-test questionnaires including Spielberger's anxiety, self-care and reproductive and sexual health literacy, and quality of life and stress will be completed by self-administered method. In case of incomplete participation in counseling sessions, the questionnaires will be completed and analyzed as Intention to Threat. Also, the missing cases will be investigated with the multiple imputation policy. Control group: . The control group will receive routine care. If the positive effect of this approach in reducing anxiety and improving self-care performance in the intervention group is confirmed at the end of the study, counseling sessions will also be provided for the control group. Average anxiety score. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Spielberger anxiety questionnaire. Mean score of fertility and sexual self-care performance. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: assessment questionnaire Reproductive and sexual self-care. Sexual health literacy. Timepoint: Before the intervention and 4 weeks after the study. Method of measurement: Sexual health literacy questionnaire for adults, SHALE. Quality of Life. Timepoint: Before the intervention and 4 weeks after the study. Method of measurement: Quality of life questionnaire for women with HPV (HPV‑QoL Human Papilloma Viral questionnaire). Stress. Timepoint: Before the intervention and 4 weeks after the study. Method of measurement: DASS-21 questionnaire. Tabriz University of Medical Sciences Approved 2024-01-10 Ethics Committee of Tabriz University of Medical Sciences Golgasht Street, Tabriz University of Medical Sciences Vice President of Research and Technology tabriz East Azarbaijan Iran (Islamic Republic of)