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IRCT20250723066609N4 IRCT 2026-02-16 Khoy University of Medical Sciences Neuman's Systems Model on sleep quality and anxiety in nulliparous pregnant women The effect of Neuman's Systems Model on sleep quality and anxiety in nulliparous pregnant women attending comprehensive health service centers in Khoy County: A randomized clinical trial 2026-01-28 anticipated 80 Complete https://irct.ir/trial/88817 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be allocated to intervention and control groups using block randomization with the individual as the unit of randomization. A statistical software (or valid random number generator) will be used to generate the random sequence and block sizes (e.g., blocks of 4). To ensure allocation concealment and prevent selection bias, the assignment sequence will be placed in sealed, opaque, and sequentially numbered envelopes. After initial assessment and obtaining informed consent from eligible mothers at the health centers, the corresponding envelope will be opened by an independent individual to reveal the group assignment. N/A nulliparous pregnant women. Intervention 1: Intervention group: The educational-care intervention program in this study is developed and implemented based on Newman's systems model, consisting of four sessions with specific objectives, content, and scheduling. The first session (30 to 45 minutes), aimed at diagnosis and evaluation, focuses on identifying actual and potential stressors (such as fear of childbirth, concerns about motherhood, and environmental problems). The mother's state of balance is determined by an initial assessment of anxiety levels and sleep quality. The second session (45 to 60 minutes) includes primary prevention interventions and aims to strengthen the mother's resilient and typical defense lines, providing content such as stress coping skills training, comprehensive sleep hygiene education, time and energy management, and the importance of social support. The third session (45 to 60 minutes) is dedicated to secondary prevention interventions, aiming to address existing stressors and strengthen lines of resistance thru targeted intervention. This will include teaching specific relaxation techniques (such as deep breathing and visualization), counselling focused on the mother's main concerns about pregnancy and childbirth, and modifying harmful behaviors. Finally, the fourth session (30-45 minutes), aimed at evaluation and reconstruction (tertiary prevention) to support a return to balance, includes reassessment of anxiety and sleep quality scores, review and consolidation of learned material, and planning for the sustainability of positive changes. If necessary, mothers requiring more specialized services are referred. Intervention 2: Control group: The control group will only receive routine and standard healthcare at the health center during this period. 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 En No further information available.
public Mir Amirhossein Seyednazari
Khoy - Basij Square - Shahid Montazeri Street - Khoy Medical Sciences Central Headquarters
Khoy Iran (Islamic Republic of) 5819637599 +98 44 3625 5777 amirhosseinseyednazari@gmail.com Khoy University of Medical Sciences scientific Mir Amirhossein Seyednazari
Khoy - Basij Square - Shahid Montazeri Street - Khoy Medical Sciences Central Headquarters
Khoy Iran (Islamic Republic of) 5819637599 +98 44 3625 5777 amirhosseinseyednazari@gmail.com Khoy Faculty of Medical Sciences Iran (Islamic Republic of) Nulliparous mothers with gestational ages between 28 and 40 weeks Obtaining informed consent from spouses and the Nulliparous mothers. Mothers visiting health centers Not taking psychiatric or sleeping medications in the past month and individuals undergoing specific treatments. no limit no limit Female Withdrawal from continued participation during the study Occurrence of acute obstetric complications (such as severe preeclampsia, severe bleeding) Delivery before the intervention is completed. Lack of cooperation in completing tools or intervention sessions Behavior Behavior Intervention group: The educational-care intervention program in this study is developed and implemented based on Newman's systems model, consisting of four sessions with specific objectives, content, and scheduling. The first session (30 to 45 minutes), aimed at diagnosis and evaluation, focuses on identifying actual and potential stressors (such as fear of childbirth, concerns about motherhood, and environmental problems). The mother's state of balance is determined by an initial assessment of anxiety levels and sleep quality. The second session (45 to 60 minutes) includes primary prevention interventions and aims to strengthen the mother's resilient and typical defense lines, providing content such as stress coping skills training, comprehensive sleep hygiene education, time and energy management, and the importance of social support. The third session (45 to 60 minutes) is dedicated to secondary prevention interventions, aiming to address existing stressors and strengthen lines of resistance thru targeted intervention. This will include teaching specific relaxation techniques (such as deep breathing and visualization), counselling focused on the mother's main concerns about pregnancy and childbirth, and modifying harmful behaviors. Finally, the fourth session (30-45 minutes), aimed at evaluation and reconstruction (tertiary prevention) to support a return to balance, includes reassessment of anxiety and sleep quality scores, review and consolidation of learned material, and planning for the sustainability of positive changes. If necessary, mothers requiring more specialized services are referred. Control group: The control group will only receive routine and standard healthcare at the health center during this period. Sleep Quality, anxiety. Timepoint: Before and After intervention. Method of measurement: Pittsburgh Questionarie, Speilberger Questionarie. Khoy University of Medical Sciences Approved 2025-12-23 Ethics committee of Khoy University of Medical Sciences Valiasr Blv Khoy West Azarbaijan Iran (Islamic Republic of)