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IRCT20140622018187N8 IRCT 2020-03-04 Shiraz University of Medical Sciences The effect of sleep and wake training on anxiety, depression and some related hormones in infertile women The impact of correct training sleep and wakefulness on anxiety, depression and some related hormones in infertile women referring to Hazrat Zeynab( P.B.U.H.) Hospital 2018-2019 2018-05-22 anticipated 130 Complete https://irct.ir/trial/43339 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The permutation block randomization method with four blocks will be used. We assign different positions to the numbers 1 to 6, respectively. Now, using the random number table, we extract the numbers from the table and, depending on one of the numbers from 1 to 6, select any of the blocks assigned to these numbers until 36 blocks of 4 are selected. If the numbers zero, 7, 8, and 9 are omitted, we will continue to provide a complete list of the total sample size in both case and control groups. N/A physical and mental health. Intervention 1: "Intervention group: 1. Conducting a workshop, 2. Weekly follow up and completing the questionnaires 1 and 6 months after the end of the intervention, 3. 6 months after intervention". Intervention 2: Control group:1. Continuing with their usual process (no intervention, no Workshop for the control group) 2. Weekly follow up and questionnaires 1 and 6 months after the end of intervention, 3. Blood tests 6 months after intervention ". 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 Because all data has not yet been analyzed and the results from them have not been published
public Sedighe Forouhari
College Of Nursing Midwifery, Shiraz
shiraz Iran (Islamic Republic of) 71345-1978 +98 71 1647 4257 forouharism@yahoo.com Shiraz University of Medical Sciences scientific Sedighe Foruhari
College Of Nursing Midwifery, Shiraz
shiraz Iran (Islamic Republic of) 71345-1978 +98 71 1647 4257 forouharism@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Poor sleep quality (greater than or equal to 5) based on the Pittsburgh questionnaire, mild depression (score less than 18) based on the Beck Depression Inventory and mild anxiety (score less than 15) based on the Beck Anxiety Inventory. Have been referred to the Infertility Center of Hazrat Zeinab Hospital for infertility treatment. Have informed consent to participate in the research and complete the relevant form Absence of mental and mental illnesses to the diagnosis of the relevant physician Absence of internal diseases to the doctor's diagnosis Absence of internal diseases to the doctor's diagnosis No stressful or disturbing event has occurred in the last 6 months Unusual situations such as traveling, changing jobs and having stressful jobs, shifting diets, and the like over the last 3 months that have caused a change in sleep patterns Not taking hormone drugs at least 4-6 weeks before blood sampling Abnormal bleeding or amenorrhea in a way that there is no possibility of bleeding on the third day of the menstrual cycle. 15 years 44 years Female Patient dissatisfaction with continuing to participate in research at each stage Incidence of each of the 4 to 10 items listed in the inclusion criteria in each research step Pregnancy at each stage of research Behavior Behavior "Intervention group: 1. Conducting a workshop, 2. Weekly follow up and completing the questionnaires 1 and 6 months after the end of the intervention, 3. 6 months after intervention" Control group:1. Continuing with their usual process (no intervention, no Workshop for the control group) 2. Weekly follow up and questionnaires 1 and 6 months after the end of intervention, 3. Blood tests 6 months after intervention " Blood hormones (TSH, FSH, LH, PROLACTIN) will be measured on day 3 of the menstrual cycle. Timepoint: Blood sampling at baseline and then 6 months after the last intervention. Method of measurement: Blood sampling and hormonal testing. Mental health. Timepoint: At the beginning of the study and 1 month and 6 months after the end of the intervention. Method of measurement: - Pittsburgh PSQI questionnaire- Beck Depression Inventory (BDI)- BAI Anxiety Inventory- Demographic questionnaire (including information on age, education, occupation and couple, history of infertility by type and cause, socioeconomic status, body mass index, distance from previous pregnancy (if secondary), medication use, smoking, alcohol and Tobacco and Paraclinical Tests and Records)Depression Inventory and Mild Anxiety (score less than 15) based on Beck Anxiety Inventory. Research Council of Shiraz University of Medical Sciences Approved 2019-01-23 Ethics committee of Shiraz University of Medical Sciences Fatemeh School of Nursing and Midwifery, Namazi Hospital, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)