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
Determining the impact of Neuman's Systems Model on sleep quality and anxiety in nulliparous mothers attending comprehensive health service centers in Khoy County in 2025.
Design
Clinical trial with a control group, parallel groups, simple randomization, Phase 0 on 80 patients.
Settings and conduct
The sampling method in this study is multi-stage. In the first stage, the city of Khoy is divided into two separate regions based on the municipal classification. Then, from among the health centers in each region, 4 centers will be randomly selected and randomly assigned to intervention (2 sites) and control (2 sites) groups; thus, the study will be conducted at 8 sites (4 intervention and 4 control). Finally, at each base, 20 women are selected at random from the list of eligible pregnant women's names.
Participants/Inclusion and exclusion criteria
Entry Requirements:
First-time mothers with a gestational age between 28 and 40 weeks
Obtaining informed consent from spouses and first-time mothers themselves.
Mothers visiting health centers
Not taking psychiatric or sleeping medications in the past month and individuals undergoing specific treatments.
Conditions for Non-Entry:
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
Intervention groups
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. If necessary, mothers requiring more specialized services will be referred.
Main outcome variables
Sleep Quality; Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250723066609N4
Registration date:2026-02-16, 1404/11/27
Registration timing:registered_while_recruiting
Last update:2026-02-16, 1404/11/27
Update count:0
Registration date
2026-02-16, 1404/11/27
Registrant information
Name
Mir Amir Hossein Seyednazari
Name of organization / entity
Khoy Faculty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3646 7036
Email address
seiednazari_a@khoyums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-28, 1404/11/08
Expected recruitment end date
2026-04-20, 1405/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Neuman's Systems Model on sleep quality and anxiety in nulliparous pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Khoy University of Medical Sciences
Street address
Valiasr Blv
City
Khoy
Province
West Azarbaijan
Postal code
5819637599
Approval date
2025-12-23, 1404/10/02
Ethics committee reference number
IR.KHOY.REC.1404.057
Health conditions studied
1
Description of health condition studied
nulliparous pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep Quality, anxiety
Timepoint
Before and After intervention
Method of measurement
Pittsburgh Questionarie, Speilberger Questionarie
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Behavior
2
Description
Control group: The control group will only receive routine and standard healthcare at the health center during this period.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Deputy Health Minister
Full name of responsible person
Dr. Bayram Hashemzadeh
Street address
میدان شهید فهمیده
City
Khoy
Province
West Azarbaijan
Postal code
5813788131
Phone
+98 44 3646 7015
Email
name@domain.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoy University of Medical Sciences
Full name of responsible person
Dr. Amin Soheili
Street address
Khoy - Basij Square - Shahid Montazeri Street - Khoy Medical Sciences Central Headquarters
City
Khoy
Province
West Azarbaijan
Postal code
5819637599
Phone
+98 44 3625 5777
Email
sci@khoyums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoy University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Khoy University of Medical Sciences
Full name of responsible person
Mir Amirhossein Seyednazari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khoy - Basij Square - Shahid Montazeri Street - Khoy Medical Sciences Central Headquarters
City
Khoy
Province
West Azarbaijan
Postal code
5819637599
Phone
+98 44 3625 5777
Email
amirhosseinseyednazari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoy Faculty of Medical Sciences
Full name of responsible person
Mir Amirhossein Seyednazari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khoy - Basij Square - Shahid Montazeri Street - Khoy Medical Sciences Central Headquarters
City
Khoy
Province
West Azarbaijan
Postal code
5819637599
Phone
+98 44 3625 5777
Email
amirhosseinseyednazari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoy Faculty of Medical Sciences
Full name of responsible person
Mir Amirhossein Seyednazari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khoy - Basij Square - Shahid Montazeri Street - Khoy Medical Sciences Central Headquarters
City
Khoy
Province
West Azarbaijan
Postal code
5819637599
Phone
+98 44 3625 5777
Email
amirhosseinseyednazari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available