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IRCT20221230056982N1 IRCT 2023-01-16 Oroumia University of Medical Sciences Evaluation of the effectiveness of the educational intervention of emotional regulation strategies based on Gross model on emotion regulation strategies and psycho-social burden of women infected with human papillomavirus Evaluation of the effectiveness of the educational intervention of emotional regulation strategies based on Gross model on emotion regulation strategies and psycho-social burden of women infected with human papillomavirus 2023-01-26 anticipated 100 Complete https://irct.ir/trial/67728 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: To select participants, the researcher will go to the specialized clinic of Kausar Medical Training Center in Urmia every day of the week. Among the clients of the clinic, women who meet the criteria for entering the study will be selected, then a brief explanation will be given to them about the goals and the work method. If there is no agreement, another person will be replaced. People will be randomly divided into two control groups (50 people) and intervention group (50 people). In this way, closed envelopes will be used for random allocation. Participants pick one envelope from among 100 envelopes in the box, 50 of which contain card "A" and the other 50 contain card "B". If they pick up the "A" card, they will be placed in the intervention group, and if they pick up the "B" card, they will be placed in the control group, Blinding description: The participants of the intervention group will be trained in 5 sessions of 45-60 minutes with a frequency of once a week, which are in the form of one-person classes, and to prevent the possibility of publishing information, the control group will be questioned first, so no one of the participants in the control and intervention groups will not be aware of the allocation of the study groups. N/A Human Papillomavirus. Intervention 1: Intervention group: After obtaining the written consent, the demographic information questionnaire, the HIP questionnaire and the Gross Emotion Regulation Scale will be completed through self-reporting. The educational intervention will be carried out based on the educational protocol of Gross's emotional regulation strategies (individually). Participants of the intervention group will be trained in 5 sessions of 45 to 60 minutes with a frequency of once a week, which are in the form of one-on-one classes. In this intervention, educational aids such as PowerPoint, animation and brochures will be used. In the last session of the intervention and three months later, the questionnaires related to the post-test will be presented and completed again. Intervention 2: Control group: After obtaining the written consent, the demographic information questionnaire, the HIP questionnaire and the Gross Emotion Regulation Scale will be completed through self-reporting. No intervention will be done for this group. At the same time as the last intervention session and 3 months later, questionnaires related to the post-test will also be presented and completed for the control group. At the end of the study and after the completion of the training sessions, in order to maintain mental health and comply with ethical principles, a training session will be conducted for the participants of the control group and training content will be provided to them. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information and the publication schedule of the article is not known.
public Dr. Roghaye Bayrami
School of Nursing and Midwifery, Pardis Nazlou, 11th km of Nazlou Highway, Urmia, Iran
Urmia Iran (Islamic Republic of) 5756115335 +98 44 3223 4897 Rozabayrami@yahoo.com Oroumia University of Medical Sciences scientific Dr. Roghaye Bayrami
School of Nursing and Midwifery, Pardis Nazlou, 11th km of Nazlou Highway, Urmia, Iran
Urmia Iran (Islamic Republic of) 5756115335 +98 44 3223 4897 Rozabayrami@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Having written informed consent to participate in the study age range of 15-49 years and married The husband knowing that his wife is infected with HPV disease The husband is infected with HPV disease Having Iranian nationality Being a resident of Urmia Having at least fifth grade literacy Definite diagnosis (by a gynecologist) during the last three months with HPV type The absence of malignant diseases Living with husband 15 years 49 years Female Occurrence of pregnancy during the study Unwillingness to cooperate in the continuation of the project Not participating in more than two educational intervention sessions Getting divorced and separated from the husband Not having sex during life Having an acute psychological incident such as losing a family member Having mental illnesses such as severe depression and consuming addictive substances during the study and the last 6 months B97.7 Papillomavirus as the cause of diseases classified to other chapters Behavior Lifestyle Intervention group: After obtaining the written consent, the demographic information questionnaire, the HIP questionnaire and the Gross Emotion Regulation Scale will be completed through self-reporting. The educational intervention will be carried out based on the educational protocol of Gross's emotional regulation strategies (individually). Participants of the intervention group will be trained in 5 sessions of 45 to 60 minutes with a frequency of once a week, which are in the form of one-on-one classes. In this intervention, educational aids such as PowerPoint, animation and brochures will be used. In the last session of the intervention and three months later, the questionnaires related to the post-test will be presented and completed again. Control group: After obtaining the written consent, the demographic information questionnaire, the HIP questionnaire and the Gross Emotion Regulation Scale will be completed through self-reporting. No intervention will be done for this group. At the same time as the last intervention session and 3 months later, questionnaires related to the post-test will also be presented and completed for the control group. At the end of the study and after the completion of the training sessions, in order to maintain mental health and comply with ethical principles, a training session will be conducted for the participants of the control group and training content will be provided to them. General psycho-social burden score of women infected with human papillomavirus. Timepoint: Measuring the general psycho-social burden score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: HIP questionnaire. Gross's emotional regulation strategies. Timepoint: Measurement of the Gross's emotional regulation strategies score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: Gross's emotion regulation questionnaire. Worries and concerns. Timepoint: Measurement of the Worries and concerns score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: HIP questionnaire. Emotional impact. Timepoint: Measurement of the emotional impact score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: HIP questionnaire. Sexual impact. Timepoint: Measurement of the sexual impact score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: HIP questionnaire. Self image. Timepoint: Measurement of the self image score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: HIP questionnaire. Partner and transmission. Timepoint: Measurement of the partner and transmission score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: HIP questionnaire. Interactions with doctors. Timepoint: Measurement of the interactions with doctors score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: HIP questionnaire. Control/life impact. Timepoint: Measurement of the control/life impact score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: HIP questionnaire. Cognitive reappraisal. Timepoint: Measurement of the cognitive reappraisal score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: Gross's emotion regulation questionnaire. Expressive suppression. Timepoint: Measurement of the expressive suppression score of infected women at the beginning of the study (before the start of the intervention) and 5 weeks later at the end of the last counseling session and 3 months later. Method of measurement: Gross's emotion regulation questionnaire. Oroumia University of Medical Sciences Approved 2022-12-03 Ethics committee of Urmia University of Medical Sciences Urmia University Of Medical Sciences, Emergency Alley, Resalat Blvd., Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)