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IRCT20180918041065N1 IRCT 2018-11-20 Ahvaz University of Medical Sciences Cognitive-Behavioral Therapy (CBT) on hot flushes in postmenopausal women Comparing Face-to-Face and Telephone-Based Cognitive Behavioral Therapy on Hot Flushes in Postmenopausal Women 2018-07-06 anticipated 40 Complete https://irct.ir/trial/34088 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, eligible individuals will be randomly assigned to two groups of telephone counseling (N=20) and face-to-face counseling (N=20) using block randomization (block size: 4 and allocation ratio: 1). For allocation concealment, 20 four digit numbers will be selected for each participant in the telephone group and face-to face group respectively and will be arranged according to the block size. Then in order to hide the allocation, the numbers will be arranged in blocks of opaque envelop, respectively and will be given randomly to eligible individuals by the secretary. N/A Hot flushes in Postmenopausal women. Intervention 1: ّFor the face-to face group, six sessions of 30 minutes each of cognitive-behavioral counseling will be held on a weekly basis for one intervention groups. These sessions composed of the following issues: expression of the rules and objectives of the study, providing information about physiology of menopause as well its complications and treatment, introducing cognitive behavioral model including physiological, cognitive,behavioral and emotional components for hot flashes and night sweats, teaching breath and relaxation techniques, emphasizing the role of stress in boosting hot flashes, night sweats and cognitive behavioral strategies for reducing it, focusing on cognitive responses(tragedy thoughts and extreme negative beliefs about hot flushes) and behavioral reactions(avoidance and activity) on hot flushes, providing weekly assignments, implementing cognitive behavioral strategies for hot flushes management, breathing techniques and relaxation for home work and finally preparing the main list of beliefs and cognition as well as their variability and methods to change negative beliefs. Intervention 2: For the telephone based counseling, there will be six sessions of 20-30 minutes telephone cognitive-behavioral counseling on a weekly basis. The content of these sessions are as follows: expression of the rules and objectives of the study, providing information on physiology of menopause as well as its complications and treatment, introducing cognitive behavioral model including physiological, cognitive,behavioral and emotional components for hot flashes and night sweats, teaching breath and relaxation techniques, emphasizing the role of stress in boosting hot flashes, night sweats and cognitive behavioral strategies for reducing it, focusing on cognitive responses(tragedy thoughts and extreme negative beliefs about hot flushes) and behavioral reactions(avoidance and activity) on hot flushes, providing weekly assignments, implementing cognitive behavioral strategies for hot flushes management, breathing techniques and relaxation for home work and finally preparing the main list of beliefs and cognition as well as their variability and methods to change negative beliefs. Yes - There is a plan to make this available What will be shared: The entire data can be shared after anonymize participants When: Data can be accessed after publication for a period of one year. To whom: Only for scholars working in the scientific institution Conditions: The data are available upon referencing name of investigators, clinical trials and research Where to obtain: Pourandokht Afshary, Faculty Member of Ahvaz Jundishapur University of Medical Sciences Email: P_afshary@yahoo.com How to obtain: Send the request via email,will be answered as soon as possible Comments:
public Porandokht Afshary
Ahvaz, Golestan Ave, Ahvaz Jundishapur University of Medical Sciences, Nursing & Midwifery School, Menopause Research Center
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8619 P_afshary@yahoo.com Ahvaz University of Medical Sciences scientific Porandokht Afshary
Ahvaz, Golestan Ave, Ahvaz Jundishapur University of Medical Sciences, Nursing & Midwifery School, Menopause Research Center
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8619 P_afshary@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Normal Menopause Passing at least one year and maximum five years from the cessation of menstruation Being able to read and write Having at least 10 hot flashes per week in a duration of one month Having a score of more than 1 in response to the kupperman index Having a cell phone 40 years 60 years Female Known Mental and Physical illnesses History of Cognitive Behavioral Therapy(CBT) Drug and other psychotropic substances abuse Under medication for hot flashes N95.1 Menopausal and female climacteric states Treatment - Other Treatment - Other ّFor the face-to face group, six sessions of 30 minutes each of cognitive-behavioral counseling will be held on a weekly basis for one intervention groups. These sessions composed of the following issues: expression of the rules and objectives of the study, providing information about physiology of menopause as well its complications and treatment, introducing cognitive behavioral model including physiological, cognitive,behavioral and emotional components for hot flashes and night sweats, teaching breath and relaxation techniques, emphasizing the role of stress in boosting hot flashes, night sweats and cognitive behavioral strategies for reducing it, focusing on cognitive responses(tragedy thoughts and extreme negative beliefs about hot flushes) and behavioral reactions(avoidance and activity) on hot flushes, providing weekly assignments, implementing cognitive behavioral strategies for hot flushes management, breathing techniques and relaxation for home work and finally preparing the main list of beliefs and cognition as well as their variability and methods to change negative beliefs. For the telephone based counseling, there will be six sessions of 20-30 minutes telephone cognitive-behavioral counseling on a weekly basis. The content of these sessions are as follows: expression of the rules and objectives of the study, providing information on physiology of menopause as well as its complications and treatment, introducing cognitive behavioral model including physiological, cognitive,behavioral and emotional components for hot flashes and night sweats, teaching breath and relaxation techniques, emphasizing the role of stress in boosting hot flashes, night sweats and cognitive behavioral strategies for reducing it, focusing on cognitive responses(tragedy thoughts and extreme negative beliefs about hot flushes) and behavioral reactions(avoidance and activity) on hot flushes, providing weekly assignments, implementing cognitive behavioral strategies for hot flushes management, breathing techniques and relaxation for home work and finally preparing the main list of beliefs and cognition as well as their variability and methods to change negative beliefs. Hot flush score in the Kupperman index. Timepoint: Hot flush at baseline, at the end of intervention, six weeks after intervention, and two months after intervention. Method of measurement: Kupperman Index. Ahvaz University of Medical Sciences Approved 2018-06-30 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Iran, Ahvaz, Golestan Blv, Ahvaz Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)