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IRCT20230718058833N1 IRCT 2023-08-29 Ahvaz University of Medical Sciences Investigating the effect of cognitive-behavioral counseling based on mindfulness on the sleep quality of mothers Investigating the effect of cognitive-behavioral counseling based on mindfulness on the sleep quality of primiparous mothers in the postpartum period 2023-09-03 anticipated 98 Complete https://irct.ir/trial/71917 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: In order to hide the random allocation, the type of intervention will be written on paper and placed inside opaque envelopes numbered consecutively, in this way, the researcher and the participant will not know the type of intervention until the intervention begins. This study will not be able to blind the researcher and the participant, Randomization description: After the initial selection of the samples, they will be divided into two groups using a random block of 6 and with an allocation ratio of 1.1. In each of the blocks, 3 people will be in the control group and 3 people will be in the intervention group. He is a random person. N/A Sleep quality. Intervention 1: Intervention group: The intervention group will be divided into 4 groups, then the intervention will be carried out in the form of a pre-test, post-test and follow-up stage, so that all the mothers of the intervention and control groups at the beginning of the study, week 8 and week 12 after the intervention of the sleep quality questionnaire will be completed by self-reporting.The purpose of this study is to determine the effectiveness of cognitive-behavioral counseling based on mindfulness on the sleep quality of primiparous mothers in the postpartum period. and if they have entry criteria and no exit criteria, the samples will be selected, at first, each eligible person will be given the same explanation about the objectives of the research and how to intervene. Completing the demographic questionnaire, the Edinburgh Depression Scale and the sleep quality questionnaire by Samples that meet the conditions for entering the study will be conducted. Counseling will be conducted by a trained researcher under the supervision of a consultant professor at the center. The women of the intervention group will undergo 8 group counseling sessions (1 session per week) with a cognitive therapy approach based on Mindfulness will be aimed at improving the quality of sleep. Sessions will be held in groups, one 45-minute session per week for 2 months according to the plan between the consultant and the clients. Intervention 2: Control group: Control group: This group consists of 49 people. In each of the blocks, 3 people will belong to the control group and 3 people will belong to the intervention group, and the order of placement of each person is random. Low sleepers will not receive any intervention, in order to comply with ethical standards, they will be given a training booklet and a summary of the contents of the sessions. Yes - There is a plan to make this available What will be shared: Only part of the demographic information of the patients and the main outcome can be shared. When: 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: Mentioning the name of the study and mentioning the name of the researchers Where to obtain: Simin Khezri, Faculty of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz How to obtain: A maximum of one month after the request Comments:
public Dr. Naheed Javadi Far
Khuzestan, Ahvaz, Golestan St., Jundishapur University of Medical Sciences, Ahvaz Faculty of Nursing and Midwifery
Ahvaz Iran (Islamic Republic of) 6135715749 +98 61 3373 8331 Nahidjavadifar_341@yahoo.com Ahvaz University of Medical Sciences scientific Dr. Naheed Javadi Far
Khuzestan-Ahvaz-Jandishapur University of Medical Sciences, Ahvaz Faculty of Nursing and Midwifery
Ahvaz Iran (Islamic Republic of) 6135715749 +98 61 3373 8331 Nahidjavadifar_341@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Primiparous mothers six months after delivery Absence of any mental or physical illness Natural birth without complications The birth of a healthy and mature baby monogamy Exclusive breastfeeding Minimum education at the end of elementary school Age range from 18 to 40 years Proficient in Persian language 18 years 40 years Female Postpartum depression (getting a score above 5.12 from the Edinburgh Depression Questionnaire) Hospitalization of the baby for any reason Getting an acute febrile illness during research Having chronic diseases such as diabetes G47 Sleep disorders Behavior N/A Intervention group: The intervention group will be divided into 4 groups, then the intervention will be carried out in the form of a pre-test, post-test and follow-up stage, so that all the mothers of the intervention and control groups at the beginning of the study, week 8 and week 12 after the intervention of the sleep quality questionnaire will be completed by self-reporting.The purpose of this study is to determine the effectiveness of cognitive-behavioral counseling based on mindfulness on the sleep quality of primiparous mothers in the postpartum period. and if they have entry criteria and no exit criteria, the samples will be selected, at first, each eligible person will be given the same explanation about the objectives of the research and how to intervene. Completing the demographic questionnaire, the Edinburgh Depression Scale and the sleep quality questionnaire by Samples that meet the conditions for entering the study will be conducted. Counseling will be conducted by a trained researcher under the supervision of a consultant professor at the center. The women of the intervention group will undergo 8 group counseling sessions (1 session per week) with a cognitive therapy approach based on Mindfulness will be aimed at improving the quality of sleep. Sessions will be held in groups, one 45-minute session per week for 2 months according to the plan between the consultant and the clients. Control group: Control group: This group consists of 49 people. In each of the blocks, 3 people will belong to the control group and 3 people will belong to the intervention group, and the order of placement of each person is random. Low sleepers will not receive any intervention, in order to comply with ethical standards, they will be given a training booklet and a summary of the contents of the sessions. Sleep quality in the Pittsburgh Questionnaireاب. Timepoint: At the beginning of the study, week 8 (immediately after the intervention), week 12 after the intervention (one month after the intervention)پ. Method of measurement: Pittsburgh Sleep Quality Questionnaire-Edinburgh Depression Scale. Sleep quality score. Timepoint: 8 weeks (immediately after the intervention) and 12 weeks after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire-Edinburgh Depression Scale. Ahvaz University of Medical Sciences Approved 2023-08-15 Ethics Committee of Ahvaz University of Medical Sciences Golestan St., Jundishapur University of Medical Sciences, Ahvaz, Nursing and Midwifery College Ahvaz Khouzestan Iran (Islamic Republic of)