The Effect of the Use of Mobile App

NCT07032402 | Completed DMC

• 1 other identifier: 04012024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effect of using the ABÖS-M mobile application, developed for mothers with newborns, on maternal knowledge, care skills, and self-efficacy levels related to Sudden Infant Death Syndrome (SIDS).

Conditions

Sudden Infant Death Syndrome

Keywords

Sudden Infant Death Syndrome; Mobile Applications; Neonatal Nursing; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (9)

• Knowledge

  The Sudden Infant Death Syndrome Knowledge Self-Assessment Form was developed by the researchers based on the safe sleep recommendations of the American Academy of Pediatrics and the relevant literature to assess mothers' knowledge levels and caregiving skills related to the causes, risk factors, and preventive interventions for Sudden Infant Death Syndrome. The form consists of a total of 28 items: 3 items assessing general knowledge about SIDS, 15 items evaluating SIDS risk factors, and 10 items evaluating protective factors. The scores obtainable from the form range from 0 to 27. An increase in the score indicates a higher level of knowledge.

  baseline (first assessment)

• Knowledge

  The Sudden Infant Death Syndrome Knowledge Self-Assessment Form was developed by the researchers based on the safe sleep recommendations of the American Academy of Pediatrics and the relevant literature to assess mothers' knowledge levels and caregiving skills related to the causes, risk factors, and preventive interventions for Sudden Infant Death Syndrome. The form consists of a total of 28 items: 3 items assessing general knowledge about SIDS, 15 items evaluating SIDS risk factors, and 10 items evaluating protective factors. The scores obtainable from the form range from 0 to 27. An increase in the score indicates a higher level of knowledge.

  2 weeks after from baseline

• Knowledge

  The Sudden Infant Death Syndrome Knowledge Self-Assessment Form was developed by the researchers based on the safe sleep recommendations of the American Academy of Pediatrics and the relevant literature to assess mothers' knowledge levels and caregiving skills related to the causes, risk factors, and preventive interventions for Sudden Infant Death Syndrome. The form consists of a total of 28 items: 3 items assessing general knowledge about SIDS, 15 items evaluating SIDS risk factors, and 10 items evaluating protective factors. The scores obtainable from the form range from 0 to 27. An increase in the score indicates a higher level of knowledge.

  at the end of the invervention program (4 weeks after from baseline)

• Care Skills

  The Sudden Infant Death Syndrome Care Skills Form was developed by the researchers based on the relevant literature to assess mothers' caregiving skills related to Sudden Infant Death Syndrome (SIDS). The form consists of 28 items and is designed as a 5-point Likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree). The form consists of 28 items measuring the frequency of performing care skills. Participants rate each item on a scale from 'Always' (5 points) to 'Never' (1 point). Total scores range from 28 to 140. An increase in the score indicates that the individual performs care skills more frequently and regularly. Items with negative wording are reverse-scored.

  baseline (first assessment)

• Care Skills

  The Sudden Infant Death Syndrome Care Skills Form was developed by the researchers based on the relevant literature to assess mothers' caregiving skills related to Sudden Infant Death Syndrome (SIDS). The form consists of 28 items and is designed as a 5-point Likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree). The form consists of 28 items measuring the frequency of performing care skills. Participants rate each item on a scale from 'Always' (5 points) to 'Never' (1 point). Total scores range from 28 to 140. An increase in the score indicates that the individual performs care skills more frequently and regularly. Items with negative wording are reverse-scored.

  2 weeks after from baseline

• Care Skills

  The Sudden Infant Death Syndrome Care Skills Form was developed by the researchers based on the relevant literature to assess mothers' caregiving skills related to Sudden Infant Death Syndrome (SIDS). The form consists of 28 items and is designed as a 5-point Likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree). The form consists of 28 items measuring the frequency of performing care skills. Participants rate each item on a scale from 'Always' (5 points) to 'Never' (1 point). Total scores range from 28 to 140. An increase in the score indicates that the individual performs care skills more frequently and regularly. Items with negative wording are reverse-scored.

  at the end of the invervention program (4 weeks after from baseline)

• Self-Efficacy

  The General Self-Efficacy Scale is a five-point Likert-type scale. For each item, participants respond to the question "How well does this describe you?" using five options ranging from "Not at all" to "Very well." Each item is scored between 1 and 5. The scale consists of 17 items and demonstrates a three-factor structure: Initiation (9 items: 2, 4, 5, 6, 7, 10, 11, 12, 17), Perseverance (5 items: 3, 13, 14, 15, 16), and Sustained Effort (3 items: 1, 8, 9). The total score ranges from 17 to 85, with higher scores indicating greater self-efficacy.

  baseline (first assessment)

• Self-Efficacy

  The General Self-Efficacy Scale is a five-point Likert-type scale. For each item, participants respond to the question "How well does this describe you?" using five options ranging from "Not at all" to "Very well." Each item is scored between 1 and 5. The scale consists of 17 items and demonstrates a three-factor structure: Initiation (9 items: 2, 4, 5, 6, 7, 10, 11, 12, 17), Perseverance (5 items: 3, 13, 14, 15, 16), and Sustained Effort (3 items: 1, 8, 9). The total score ranges from 17 to 85, with higher scores indicating greater self-efficacy.

  2 weeks after from baseline

• Self-Efficacy

  The General Self-Efficacy Scale is a five-point Likert-type scale. For each item, participants respond to the question "How well does this describe you?" using five options ranging from "Not at all" to "Very well." Each item is scored between 1 and 5. The scale consists of 17 items and demonstrates a three-factor structure: Initiation (9 items: 2, 4, 5, 6, 7, 10, 11, 12, 17), Perseverance (5 items: 3, 13, 14, 15, 16), and Sustained Effort (3 items: 1, 8, 9). The total score ranges from 17 to 85, with higher scores indicating greater self-efficacy.

  at the end of the invervention program (4 weeks after from baseline)

Study Arms (2)

Experimental: Group I

EXPERIMENTAL

Behavioral and Counseling

Behavioral: Education and Counseling

Control: Group II

OTHER

Standard Care

Other: Standard Care

Interventions

Education and Counseling BEHAVIORAL

Mothers who consent will have the ABÖS-M App installed on their smartphones and will create a personal login. Researchers will provide brief training on how to use the app. The intervention consists of four educational modules designed with individualized and gamified content. Mothers are expected to complete all modules within two weeks. The app monitors their progress and provides automated feedback based on their performance, encouraging mothers to review topics if needed. Weekly WhatsApp reminders will be sent to promote app engagement, and researchers will track login frequency and usage time. Mothers who fail to complete the modules within the specified timeframe will be excluded from the study. Participants will also be asked to fill out a daily care diary throughout the intervention period.

Experimental: Group I

Standard Care OTHER

After obtaining written and verbal consent, the ABÖS-M App will be installed on their smartphones, and researchers will provide face-to-face instructions on its basic use. Mothers in the control group will receive routine newborn care education provided by clinical nurses, which includes non-standardized safe sleep information typically given before hospital discharge. No structured or individualized training will be provided by the researchers during the study period. For one month, control group participants will have limited access to certain app features, including the "About Us" section, care diary, and assessment tools. Mothers will be asked to complete the care diary daily, and researchers will send regular reminders.

Control: Group II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers with a healthy newborn baby,
• Mothers who have not experienced any previous child loss,
• Mothers with at least a primary school education,
• Mothers who own a smartphone with mobile internet access,
• Mothers who speak Turkish, are able to understand written and spoken information, follow instructions, and have no communication barriers,
• Mothers who voluntarily agree to participate in the study.

You may not qualify if:

• Mothers with postpartum depression,
• Mothers who do not complete the educational program within 15 days,
• Mothers who request withdrawal from the study at any stage.

Sponsors & Collaborators

• Amasya University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sudden Infant Death

Interventions

Educational Status; Counseling; Standard of Care

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: January 1, 2025
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-06

Locations

TU (1)