The Effect of Video-Assisted Sudden Infant Death Syndrome Prevention Training Program and Counseling Practice on Mothers' Knowledge Level and Self-efficacy: Randomized Controlled Study

NCT05823051 | Unknown

• 1 other identifier: AUDilaraAT
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sudden Infant Death Syndrome (SIDS) is one of the leading causes of infant mortality in the postneonatal period, but it can be prevented and its incidence can be reduced by creating a safe sleep environment with modifiable risk factors. It is known that parents, infant care providers and healthcare professionals do not have sufficient knowledge about SIDS and safe sleep, and especially mothers exhibit many risky behaviors in terms of SIDS, such as using the wrong sleeping positions while putting their babies to sleep. Therefore, it is of critical importance to inform and raise awareness of parents on the issues of SIDS and safe sleep, which remain important today, on the premise of promoting public health.

Conditions

Sudden Infant Death

Keywords

Sudden Infant Death Syndrome; Nursing; Parent Education; Educational Program; Prevention

Outcome Measures

Primary Outcomes (4)

• Sudden Infant Death Syndrome Knowledge Level Assessment Form 1

  This form was developed by the researchers in line with the literature and consists of 33 items to measure the level of knowledge about SIDS.

  Before the training

• Sudden Infant Death Syndrome Knowledge Level Assessment Form 2

  This form was developed by the researchers in line with the literature and consists of 33 items to measure the level of knowledge about SIDS.

  1 month after the training

• General Self-Efficacy Scale 1

  "General Self-Efficacy Scale" is a five-point Likert-type scale consisting of 17 items. The question "How well does it describe you?" has five options ranging from "not at all" to "very well". The total score of the scale ranges between 17-85, and the higher the score, the higher the self-efficacy belief.

  Before the training

• General Self-Efficacy Scale 2

  "General Self-Efficacy Scale" is a five-point Likert-type scale consisting of 17 items. The question "How well does it describe you?" has five options ranging from "not at all" to "very well". The total score of the scale ranges between 17-85, and the higher the score, the higher the self-efficacy belief.

  1 month after the training

Secondary Outcomes (3)

• Personal Information Form

  Before the training

• DISCERN Scale

  After the training videos are created

• System Usability Scale (SUS)

  Pre-application

Study Arms (2)

VASIDS-TP and Counseling Practice

EXPERIMENTAL

Video-Assisted Sudden Infant Death Syndrome Prevention Training Program (VASIDS-TP) and Counseling Practice

Other: VASIDS-TP and Counseling Practice

Routine Care

NO INTERVENTION

The control group will receive routine care in the obstetric ward. A pre-test will be conducted using the Google Survey form. "Personal Information Form", "Sudden Infant Death Syndrome Knowledge Level Assessment Form" (Pre-Test) and "General Self-Efficacy Scale" will be completed at this stage. The mothers in the control group will receive the training included in clinical routine care. The mothers in this group will not receive any planned structured training by the researchers during the study. The mothers in the control group will be administered the "Sudden Infant Death Syndrome Knowledge Level Assessment Data Form" and the "General Self-Efficacy Scale" with the Google survey that will be sent to their phones 1 month after the pre-test application. After the completion of the study, the control group will receive the same intervention (VASIDS-TP) as the intervention group.

Interventions

VASIDS-TP and Counseling Practice OTHER

VASIDS-TP will be implemented online as an individual training to the intervention group through the Microsoft Teams program, to be completed in 5 days-5 sessions in the time frames determined by the participants. The consultancy practice will start with a pre-test and participants will be assured that they can call the researcher 24/7, and the consultancy practice will be continued by phone call or messaging.

VASIDS-TP and Counseling Practice

Eligibility Criteria

• Gender Eligibility Details: women who have just given birth
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The one who has just given birth,
• With a healthy newborn baby,
• Speaks, understands and can read and write Turkish and has no barriers to communication,
• Able to use the internet, telephone and e-mail actively,
• Mothers who voluntarily agreed to participate in the study will be included.

You may not qualify if:

• Have not attended at least 3 sessions of the training program,
• Mothers who indicate that they want to leave the study while the research is ongoing will be excluded.

Sponsors & Collaborators

• Dilara Aydin Tozlu: lead

Related Publications (1)

• Hutton JS, Gupta R, Gruber R, Berndsen J, DeWitt T, Ollberding NJ, Van Ginkel JB, Ammerman RT. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population. Acad Pediatr. 2017 Nov-Dec;17(8):879-886. doi: 10.1016/j.acap.2017.04.018. Epub 2017 Apr 24.

  PMID: 28450082 BACKGROUND

MeSH Terms

Conditions

Sudden Infant Death

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dilara AYDIN TOZLU, Master's degree

CONTACT

dilara.aydinn.da@gmail.com

Emine EFE, Professor

CONTACT

02423106103; eefe@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: As a randomization method, "simple randomization method" will be used to ensure an equal number of samples in the two groups and to prevent bias. In addition, during the data analysis phase, the database will be created by an academician independent of the researcher providing the training.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: The study was planned as a randomized controlled, parallel, double centered and double blind study.

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: April 21, 2023
• Study Start: July 1, 2023
• Primary Completion: October 15, 2023
• Study Completion: November 15, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share