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IRCT2017060734378N1 IRCT 2017-07-15 Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences Comparing the effect of training, based on continuous care model and a telehealth on sleeping quality Comparing the effect of training, based on continuous care model and a telehealth on pregnant women sleeping quality 2017-07-23 anticipated 90 Complete https://irct.ir/trial/26278 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The name of the center has been used to randomize the lottery method. Lottery in the name of health centers has been done to locate each group in each health facility. 2-3 Sleep. Intervention 1: Control group: usual care health center receives over 8 weeks. Intervention 2: Intervention 2: In the Telehealth group, first they become familiar with the stages of the research between the 16th to 20th weeks of pregnancy (30-45 minutes), then 4 coded CDs (60-65 minutes) with the contents of the health and healthy behaviors during sleep is given to moms and they will be advised to watch a CD every week, during these 4 weeks and 4 weeks after that (8 weeks), telephone counseling is provided for 10-15 minutes based on the need of the patient (once a week ), Each telephone consultation includes 2 sections, the first part of the consultation is based on the content of the weekly CD, and the second part will be dedicated to the specific needs of each client and the presentation of proposed solutions. Then, the quality of sleep will be evaluated immediately and 4 weeks after the intervention (totally 12 weeks). Intervention 3: Intervention 1: In the group which its education is based on continuous care model, in first meeting (45-30 minutes) pregnant women in 16 to 20 weeks of pregnancy with a family member, after completing the survey device, become familiar with the research steps (orientation) then four 90-60 minutes sessions with consultation, discussion and Q & A ,with the contents of the health and healthy behaviors during sleep are held in 4 weeks and communication with his family is established by phone and booklet(sensitization ).If, it is needed, to study new problems, maintaining connection with mother, answer to her questions and review the lists some meetings with phone calls (10 minutes)will be held (control) and in the evaluation phase, sleep quality will be discussed immediately and 4 weeks later (totally 12 weeks). 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 the study is not finished yet.
public Fatemeh Jalalmarvi
Ibn Sina street; Doctora Crossroads
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3859 1511 Jalalmarvif941@mums.ac.ir Mashhad University of Medical Sciences scientific Masumeh Kordi
Ibn Sina street; Doctora Crossroads
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3859 1511 Kordim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) have Spontaneous written consent Being Iranian and resident of Mashhad The gestational age is between 16 and 20 weeks Pregnancies with one fetus Mother`s age between 18 to 35 The least literacy of mother and her husband be about fifth grade elementary school In response to the Pittsburgh Sleep Quality Questionnaire, she earns 5 scores and more In response to the restless leg assessment Questionnaire, she earns 3-0 scores In response to STOP Questionnaire , she earns 2-0 scores In response to question 1, the intensity of ISI Questionnaire , she earns 0-5 scores In response to stress , anxiety and depression Questionnaire less than 10, 14, and 17 scores were obtained from depression, anxiety and stress levels; Having fixed or mobile phone numbers 18 years 35 years Female linguistic, audio or dialectal problems Having sleep disorders history before pregnancy A bad important event has been occured from three months before the commencement of the study Having medical disease Having mental illness Having midwifery problems Having history of infertility and the current pregnancy does be a result of infertility treatment Pre-pregnancy BMI does be equal to or greater than 30 Having addiction to tobacco (hookah, cigarettes, cheeks, drugs) or alcohol and psychosocial drugs, research unit or his husband During the research she does have night shift work G47.0 Disorders of initiating and maintaining sleep [insomnia] N/A N/A N/A Control group: usual care health center receives over 8 weeks Intervention 2: In the Telehealth group, first they become familiar with the stages of the research between the 16th to 20th weeks of pregnancy (30-45 minutes), then 4 coded CDs (60-65 minutes) with the contents of the health and healthy behaviors during sleep is given to moms and they will be advised to watch a CD every week, during these 4 weeks and 4 weeks after that (8 weeks), telephone counseling is provided for 10-15 minutes based on the need of the patient (once a week ), Each telephone consultation includes 2 sections, the first part of the consultation is based on the content of the weekly CD, and the second part will be dedicated to the specific needs of each client and the presentation of proposed solutions. Then, the quality of sleep will be evaluated immediately and 4 weeks after the intervention (totally 12 weeks). Intervention 1: In the group which its education is based on continuous care model, in first meeting (45-30 minutes) pregnant women in 16 to 20 weeks of pregnancy with a family member, after completing the survey device, become familiar with the research steps (orientation) then four 90-60 minutes sessions with consultation, discussion and Q & A ,with the contents of the health and healthy behaviors during sleep are held in 4 weeks and communication with his family is established by phone and booklet(sensitization ).If, it is needed, to study new problems, maintaining connection with mother, answer to her questions and review the lists some meetings with phone calls (10 minutes)will be held (control) and in the evaluation phase, sleep quality will be discussed immediately and 4 weeks later (totally 12 weeks) Sleep quality. Timepoint: Before the intervention, immediately after intervention and 4 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index. Severe insomnia. Timepoint: Before, immediately after and 4 weeks after intervention. Method of measurement: Insomnia Severity Index. Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences Approved 2017-06-03 The Ethics Committee of Mashhad University of Medical Sciences Contact Number 38411538-051; Fax Number 38430249-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)