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IRCT20220526054996N1 IRCT 2022-06-11 Yazd University of Medical Sciences Comparison of online emotion regulation therapy(ERT) and online guided imagery therapy (GIT) on sexual anxiety in women with endometrial and ovarian cancer Effectiveness comparison of online emotion regulation therapy (ERT) and online guided imagery therapy (GIT) on sexual anxiety in women with endometrial and ovarian cancer 2022-07-06 anticipated 64 Complete https://irct.ir/trial/63860 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible women are selected through convenience sampling method and randomly allocated using random numbers sequence that prepared by biostatistician (using the site www.random.org/sequences/) assigned into group emotion regulation Therapy (ERT) or guided imagery Therapy (GIT) (32 women in each group) by investigator based on the output of the software. Both investigator and women are not aware the name of group that each woman will be allocated. Each woman is given a code between 1 and 64. Allocation concealment is performed using closed envelope. Again, each group is randomly allocated into two subgroups of 16 women by a collogue out of research team. Thus, the study is performed with the two main groups of emotion regulation Therapy group (n = 32 ERT) and guided imagery Therapy (n = 32 GIT), which includes four subgroups of 16 women. N/A Sexual anxiety counseling. Intervention 1: Intervention group: The intervention in the emotion regulation group is done online and in a group counseling method in the Skyroom and WhatsApp in 8 sessions of 60 minutes, once a week by the second investigator under the supervision of the first and the fourth couple therapist investigators. Content of sessions includes psychoeducation for sexual performance, psychoeducation for emotion and sexual emotion regulation, selection of situation and acceptance to emotional sexual response, correction of situation, extension of attention and reevaluation , self acceptance and compassion, regulation of sexual response. At the beginning of each session, a summary of the content of the previous sessions will be reviewed and the tasks assigned to the previous session will be reviewed by the counselor to assess the state of sexual anxiety improvement in each session. Women are asked to participate in online counseling discussions and ask questions. The consultant will also ask questions about the topics of the meeting to get more women involved. At the end of each session, a summary of the important issues is presented and the questions of the individuals are answered and the women are asked to do their homework until the next session. Intervention 2: Intervention group: The intervention in the Guided imagery group is done online and in a group in the Skyroom and WhatsApp space in 8 sessions of 60 minutes, once a week by the second investigator under the supervision of the first and the fourth couple therapist investigators. Content of sessions includes psychoeducation for familiar with GIT, recognition of disturbance images and thoughts and their relation with sexual mood and sexual behavior, training of guided imaginary skills, thoughts rotation training and thoughts review, cognitive reconstruction of negative sexual thoughts, evaluation of sexual negative thoughts management , and assessment of sexual behaviors. At the beginning of each session, a summary of the content of the previous sessions will be reviewed and the tasks assigned to the previous session will be reviewed by the counselor to assess the state of sexual anxiety improvement in each session. Women are asked to participate in online counseling discussions and ask questions. At the end of each session, a summary of the important issues is presented and the questions of the individuals are answered and the women are asked to do their homework until the next session. Yes - There is a plan to make this available What will be shared: All personal data of study participants can be shared after un identifying. When: After results publication. To whom: The data will be available to researchers working in academia and academia, and people in the industry can apply for it. Conditions: Scientific usage. Where to obtain: farajkhoda_t@yahoo.com How to obtain: One week after receiving requested email. Comments:
public Tahmineh Farajkhoda
Bouali ave
Yazd Iran (Islamic Republic of) ۸۹۱۶۸۷۷۴۴۳ +98 35 3824 1754 farajkhoda_t@yahoo.com Yazd University of Medical Sciences scientific Tahmineh Farajkhoda
Bouali Ave
Yazd Iran (Islamic Republic of) ۸۹۱۶۸۷۷۴۴۳ +98 35 3824 1754 farajkhoda_t@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Age (18 to 65 years) Having Endometrial and Ovarian cancer Women able to have sex after at least 6 weeks of surgery or final chemotherapy Ability to participate in counseling sessions Having an Android or iOS smartphone Ability to use online consultation with a smart phone Having Sexual Anxiety based on the Davis Sex Anxiety Questionnaire Married women and having intercourse with her spouse Women consent to participate in the research Ability to understand and speak Persian Collaborate in performing tasks 18 years 65 years Female Recurrence of cancer Hospitalization of patients for any reason Women undergoing vaginal brachytherapy Women undergoing chemotherapy on time of sampling Women under radiation on time of sampling Women who have not had a hysterectomy in the presence of cancer Women with severe mental illness Neurological disorders Addiction to drugs and alcohol Women with severe surgical complications like fistula or urine/stool incontinency Z70 Counseling related to sexual attitude, behavior and orientation Behavior Behavior Intervention group: The intervention in the emotion regulation group is done online and in a group counseling method in the Skyroom and WhatsApp in 8 sessions of 60 minutes, once a week by the second investigator under the supervision of the first and the fourth couple therapist investigators. Content of sessions includes psychoeducation for sexual performance, psychoeducation for emotion and sexual emotion regulation, selection of situation and acceptance to emotional sexual response, correction of situation, extension of attention and reevaluation , self acceptance and compassion, regulation of sexual response. At the beginning of each session, a summary of the content of the previous sessions will be reviewed and the tasks assigned to the previous session will be reviewed by the counselor to assess the state of sexual anxiety improvement in each session. Women are asked to participate in online counseling discussions and ask questions. The consultant will also ask questions about the topics of the meeting to get more women involved. At the end of each session, a summary of the important issues is presented and the questions of the individuals are answered and the women are asked to do their homework until the next session. Intervention group: The intervention in the Guided imagery group is done online and in a group in the Skyroom and WhatsApp space in 8 sessions of 60 minutes, once a week by the second investigator under the supervision of the first and the fourth couple therapist investigators. Content of sessions includes psychoeducation for familiar with GIT, recognition of disturbance images and thoughts and their relation with sexual mood and sexual behavior, training of guided imaginary skills, thoughts rotation training and thoughts review, cognitive reconstruction of negative sexual thoughts, evaluation of sexual negative thoughts management , and assessment of sexual behaviors. At the beginning of each session, a summary of the content of the previous sessions will be reviewed and the tasks assigned to the previous session will be reviewed by the counselor to assess the state of sexual anxiety improvement in each session. Women are asked to participate in online counseling discussions and ask questions. At the end of each session, a summary of the important issues is presented and the questions of the individuals are answered and the women are asked to do their homework until the next session. Measurement of mean sexual anxiety scores in women with endometrial and ovarian cancer. Timepoint: At the baseline,Completion of the intervention in week 8 and follow-up completion of the study in week 12 in two groups. Method of measurement: Sexual Anxiety Questionnaire (Davis and et al.). Mean score of wife attitude toward her spouse sexual satisfaction in two groups. Timepoint: Baseline, completion of the intervention in week 8 and follow-up of study completion in week 12. Method of measurement: With a question on a visual scale of spouse sexual satisfaction in view of wife between 1-10 by the method of self-reporting by women. Yazd University of Medical Sciences Approved 2022-05-18 Ethics committee of Shahid Sadoughi University of Medical Sciences Bahonar Square,Yazd Yazd Yazd Iran (Islamic Republic of)