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IRCT20201102049233N3 IRCT 2023-09-02 Hamedan University of Medical Sciences Sleep hygiene education and the insomnia severity and sleep quality of pregnant women The effect of sleep hygiene education on the insomnia severity and sleep quality of pregnant women 2023-09-06 anticipated 70 Complete https://irct.ir/trial/72066 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to assign mothers to the intervention and control groups, a 4 and 6 random blocking method is used. To do this, the allocation sequence is first determined using AABB blocks before the start of the study. Then, the type of intervention is written in opaque closed envelopes based on the specified sequence and is numbered in sequence. Participants will complete a demographic and midwifery information questionnaire and receive an envelope before entering the study. People are then placed in one of the control or intervention groups based on the contents of the envelope. N/A Pregnancy. Intervention 1: Intervention group: Pregnant women in the intervention group, in addition to routine care, will participate in 4 sessions of sleep hygiene education in groups of 5 people. The sessions are weekly and start from the gestational age of 24-28 weeks, and the meeting place will be held in comprehensive health centers of Nahavand city. The time of attendance is determined by prior coordination of pregnant women and by phone. The duration of the sessions will be 45-60 minutes. After the sessions, the training package is given to the participants to carry out the taught principles until the end of the pregnancy. Intervention 2: Control group: Routine prenatal care. Yes - There is a plan to make this available What will be shared: All data will be accessible if necessary When: After the results are published To whom: The data will be provided to academic and scientific institutions if necessary Conditions: If a meta-analysis is required, the data will be made available to the corresponding author Where to obtain: Correspondence with the responsible person by email How to obtain: If you agree to the request, the data will be emailed. Comments:
public Farideh Kazemi
Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
Hamedan Iran (Islamic Republic of) 08138380150 +98 81 3838 0150 faridehkazemi21@yahoo.com Hamedan University of Medical Sciences scientific Farideh Kazemi
Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
Hamedan Iran (Islamic Republic of) 08138380150 +98 81 3838 0150 faridehkazemi21@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Be 18-35 years old. The pregnancy is a singleton. The gestational age at the time of entering the study should be 24-28 weeks. Be literate in reading and writing. Have obtained SHI (Sleep Hygiene Index) score ≥ 16. Have the ability to speak Persian. 18 years 35 years Female According to the person's own statements, have a sleep disorder before pregnancy have chronic medical problems (such as diabetes, blood pressure, heart, kidney problems, etc.). Have pregnancy complications (gestational diabetes, pregnancy blood pressure, bleeding, placental abruption, and placenta previa). have psychiatric disorders according to the file in the SIB system Have a night shift Have cognitive problems O99.3 Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium Lifestyle Lifestyle Intervention group: Pregnant women in the intervention group, in addition to routine care, will participate in 4 sessions of sleep hygiene education in groups of 5 people. The sessions are weekly and start from the gestational age of 24-28 weeks, and the meeting place will be held in comprehensive health centers of Nahavand city. The time of attendance is determined by prior coordination of pregnant women and by phone. The duration of the sessions will be 45-60 minutes. After the sessions, the training package is given to the participants to carry out the taught principles until the end of the pregnancy. Control group: Routine prenatal care Sleep quality scores. Timepoint: Before the intervention and 4 weeks after the end of the educational sessions. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Sleep hygiene and insomnia severity. Timepoint: Before the intervention and 4 weeks after the end of the educatinal sessions. Method of measurement: Sleep Hygiene Index (SHI) and Insomnia Severity Index (ISI). Hamedan University of Medical Sciences Approved 2023-08-26 Ethics committee of Hamadan University of Medical Sciences In front of Mardom's Park, Research Square Hamedan Hamadan Iran (Islamic Republic of)