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

Sponsor
Dilara Aydin Tozlu (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05823051
Collaborator
(none)
80
2
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: VASIDS-TP and Counseling Practice
N/A

Detailed Description

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 health 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 utmost 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. In addition, informing mothers about the risk factors to protect their babies from SIDS, encouraging them to create and maintain a safe sleep environment, and ensuring that they are pioneers in this regard are also of great importance in terms of sharing information with other infant care providers in their social life. SIDS occurs in the postpartum period and has high values in infant mortality rates. For this reason, it is predicted that awareness on this issue will be significantly increased by providing education to new mothers at the earliest period and that SIDS can be prevented significantly by providing safe sleep environments. At the same time, based on the effect of self-efficacy perceptions of new mothers on the care of the baby, it is thought that the training and counseling practice planned to be given to mothers about SIDS will have a positive effect on the self-efficacy perceptions of mothers. When the relevant literature was examined, it was found that there were not enough studies on this subject in our country.

The aim of this study was to evaluate the effect of video-assisted Sudden Infant Death Syndrome prevention training program and counseling on mothers' knowledge level and self-efficacy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study was planned as a randomized controlled, parallel, double centered and double blind study.The study was planned as a randomized controlled, parallel, double centered and double blind study.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
Akdeniz University
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Oct 15, 2023
Anticipated Study Completion Date :
Nov 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: VASIDS-TP and Counseling Practice

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

Other: VASIDS-TP and Counseling Practice
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.

No Intervention: Routine Care

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.

Outcome Measures

Primary Outcome Measures

  1. Sudden Infant Death Syndrome Knowledge Level Assessment Form 1 [Before the training]

    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.

  2. Sudden Infant Death Syndrome Knowledge Level Assessment Form 2 [1 month after the training]

    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.

  3. General Self-Efficacy Scale 1 [Before the training]

    "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.

  4. General Self-Efficacy Scale 2 [1 month after the training]

    "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.

Secondary Outcome Measures

  1. Personal Information Form [Before the training]

    The "Personal Information Form" developed by the researchers in line with the literature includes multiple-choice questions about mother, baby and sleep environment.

  2. DISCERN Scale [After the training videos are created]

    The training videos developed by the researchers will be evaluated by experts using DISCERN. Basically, it was developed to assess the quality of written and technology-based educational materials prepared to inform individuals about health and treatment options. The DISCERN scale consists of 16 items and each question is scored from 1 to 5. A score in the range of 15-75 is obtained by summing the responses from each item. In the evaluation, a low total score indicates poor quality and a high score indicates good quality.

  3. System Usability Scale (SUS) [Pre-application]

    In the test phase of the developed VASIDS-TP, SUS will be applied to evaluate the experiences of mothers (users). The whole scale consists of 10 questions. Each question has a value from 1 to 5 according to the answer given. SUS Score value is obtained between 0-100. SUS Score values of 68 points and above are considered above average, while values below 68 points are considered below average.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Dilara Aydin Tozlu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dilara Aydin Tozlu, Research Assistant, Akdeniz University
ClinicalTrials.gov Identifier:
NCT05823051
Other Study ID Numbers:
  • AUDilaraAT
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dilara Aydin Tozlu, Research Assistant, Akdeniz University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2023