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Evaluating the effect of educational interventions (mobile application and training booklet) to manage the anxiety of mothers of neonates hospitalized in the neonatal intensive care unit, the protocol of randomized controlled trial.

Evaluating the effect of educational interventions (mobile application and training booklet) to manage the anxiety of mothers of neonates hospitalized in the neonatal intensive care unit, the protocol of randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230717058814N1
Enrollment
76
Registered
2024-08-14
Start date
2024-10-11
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety disorder. Other mixed anxiety disorders

Interventions

Intervention 1: Intervention group: The mobile application will be provided to the mothers of babies hospitalized in the neonatal intensive care unit in the intervention group, and the necessary expla

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Mothers will be included in the study who have the necessary information literacy to understand the questions of the questionnaire. Mothers in the intervention group should have a smart mobile phone and their mobile phone should allow installing and using this application. The number of births and the age of the mothers do not have any restrictions for entering the study.

Exclusion criteria

Exclusion criteria: Mothers who are hospitalized due to illness or childbirth complications or caesarean section are excluded from the study. Mothers of both studied groups will be excluded from the study if they use any training other than the routine training

Design outcomes

Primary

MeasureTime frame
The primary outcome will be to measure the level of anxiety of the intervention and control group participants, who will use training programs during the one-week intervention period. Timepoint: The first and end of the intervention. Method of measurement: The level of anxiety will be measured using a 21-item Beck questionnaire that includes feelings, emotions and different body states. In this questionnaire, the answers to the questions are on a 4-point Likert scale from not at all to severe and the score ranges from 0 to 63. to be The level of anxiety in the intervention group will be compared by the mindfulness method and in the comparison group by the training booklet method during the period of one week between the two groups.

Secondary

MeasureTime frame
The present study aims to assess and compare the effect of the application with booklet on the rate of anxiety and age, educational level, the Incidence and number of maternal abortions. The present study will also explore usability satisfaction. The efficiency of the application is measured by the participation. Timepoint: This specific outcome will be measured before and after the implementation of the intervention. Method of measurement: This outcome will be measured using a demographic questionnaire and Beck's anxiety questionnaire.;The next secondary outcome will be to investigate and compare the effect of using the mobile application and the booklet on the level of anxiety and the education level of mothers. Timepoint: This specific outcome will be measured before and after the implementation of the intervention. Method of measurement: This outcome will be measured using a demographic questionnaire and Beck's anxiety questionnaire.;The next secondary outcome will be to investigate and compare the effect of using the mobile app and the booklet on the level of anxiety and the number of abortions of the mother. Timepoint: This specific outcome will be measured before and after the implementation of the intervention. Method of measurement: This outcome will be measured using a demographic questionnaire and Beck's anxiety questionnaire.;The present study will also examine mothers' satisfaction with the application's usability. Timepoint: The outcome of usability satisfaction will be measured after the implementation of the intervention. Method of measurement: Usability satisfaction is measured via the Questionnaire for User Interaction Satisfaction (QUIS). A post-implementation survey will be conducted to assess participant satisfaction with application usability. It measures overall end-user subjective satisfaction with application usability along the dimensions of the application's screen (three questions), the application's information and terminologies (six que

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSadegheh Hatami Nejad

Kerman University of Medical Sciences

sadegheh.hatami@gmail.com+98 913 764 2618

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026