BreastfeedingNCT05221463
The Effect of Video-assisted Breastfeeding Education Given to Mothers of Hospitalized Newborns on Breastfeeding
A study testing Video-assisted breastfeeding training and The hospital's routine general breastfeeding training in people with Breastfeeding and Intensive Care Units, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Breastfeeding rates of infants in intensive care units in the world and in Turkey are undesirably low due to the conditions of infants, mothers and healthcare workers, which threatens the health of newborns in many aspects in the early and future periods. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Intensive Care Units, Neonatal
- What is being tested?
- Video-assisted breastfeeding training and The hospital's routine general breastfeeding training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 25 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- wanting to participate
- healthy
- 18 years and older
- the baby is hospitalized and breastfed by the neonatologist is deemed appropriate
- able to read and write
- no psychiatric problems
- mothers who speak Turkish
Who cannot join
- unwilling to participate
- patient
- breast-feeding not approved by the neonatologist
- having breast problems that prevent breastfeeding
- mental, cognitive, psychiatric, hearing and vision problems
- illiterate
- mothers who do not speak Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Health, Application and Research Center
Samsun
About this study
Official title: The Effect of Video-assisted Breastfeeding Education Given to Mothers of Hospitalized Newborns on Breastfeeding Self-efficacy and Breastfeeding Success: A Quasi-experimental Study
Breastfeeding rates of infants in intensive care units in the world and in Turkey are undesirably low due to the conditions of infants, mothers and healthcare workers, which threatens the health of newborns in many aspects in the early and future periods. It is thought that the visual materials and tools used in breastfeeding education can be effective both in the permanence of the acquired knowledge and in the transformation of the knowledge into behavior. This study was conducted to determine the effect of video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns on breastfeeding self-efficacy and breastfeeding success.
Hypotheses Hypothesis 01: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns does not affect breastfeeding self-efficacy of mothers.
Read more
Hypothesis 1: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns increases mothers' breastfeeding self-efficacy.
Hypothesis 02: Video-assisted breast milk and breastfeeding education given to mothers of hospitalized newborns does not affect mothers' breastfeeding success.
Hypothesis 2: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns increases the breastfeeding success of mothers.
This research is a non-randomized quasi-experimental study in a two-group pretest-posttest design. The research was carried out in the neonatal intensive care level 2 unit of a university hospital located in the north of Turkey. In the study, mothers who met the inclusion criteria were assigned to the education group (EG) (n=44) and the control group (CG) (n=44), some mothers did not continue the education program and left the study. In this case, the study was completed with 41 mothers in EG and 43 mothers in CG. Video assisted breastfeeding training was given to the intervention group. Only the hospital's routine general breastfeeding training was given to the control group, and no other intervention was made.Breastfeeding self-efficacy with the Postpartum Breastfeeding Self-Efficacy Scale-Short Form and breastfeeding success levels with the LATCH Breastfeeding Diagnostic Measurement Tool were evaluated at the beginning of the study (pretest) and after three days of breastfeeding training (posttest).
Read the detailed description
Breastfeeding rates of infants in intensive care units in the world and in Turkey are undesirably low due to the conditions of infants, mothers and healthcare workers, which threatens the health of newborns in many aspects in the early and future periods. The education given to the mother by health care professionals; It has a great effect on the initiation and maintenance of breastfeeding, prevention of breast complications and successful breastfeeding. It is thought that the visual materials and tools used in breastfeeding education can be effective both in the permanence of the acquired knowledge and in the transformation of the knowledge into behavior. This study was conducted to determine the effect of video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns on breastfeeding self-efficacy and breastfeeding success.
This research is a non-randomized quasi-experimental study in a two-group pretest-posttest design. The research was carried out in the neonatal intensive care level 2 unit of a university hospital located in the north of Turkey.
The universe of the study consisted of mothers who were hospitalized in the neonatal intensive care unit of the hospital where the study was conducted between 01.06.2021 and 25.12.2021 and came to breastfeed. Power analysis was performed using the G*Power (v3.1.7) program to determine the number of samples.In the calculation made by assuming that the evaluations to be made between two independent groups will have a large effect (d=0.80) on the Breastfeeding Self-Efficacy Scale-Short Shape scale scores (Tokat et al. 2010), in order to obtain 80% power (1-β) at the α=0.05 level. It was determined that there should be at least 36 people in each group. Considering that there may be losses during the research process, it was planned to recruit 44 people to each group. Three of the mothers (n=44) who met the inclusion criteria and were included in the training group (EG), and one of the mothers (n=44) who were included in the control group (KG) dropped out of the study by not continuing the training program. In this case, the study was completed with 41 mothers in EG and 43 mothers in CG.
The suitability of the mothers who came to the neonatal intensive care unit to breastfeed their babies was evaluated by the researcher. The mothers who were willing and able to participate in the study were given the necessary information about the study and their written consent was obtained. The study had an intervention and a control group. The researcher first gave video-assisted breastfeeding training to the intervention group for 3 days. On the third day after the training, feedback was received from the applications in the video regarding the knowledge and skills of the mother, and the mother's questions were answered. When these trainings were completed, other eligible mothers were included in the control group. The control group was given only the hospital's routine general breastfeeding training for 3 days and the questions of the mother were answered. The mothers in this group performed the routine breastfeeding process and no other interventions were made.
First of all, sociodemographic and obstetric data of the mothers were collected by using the introductory information form, and information about the infants was obtained by the researcher from the infants' files. Breastfeeding self-efficacy with the Postpartum Breastfeeding Self-Efficacy Scale-Short Form and breastfeeding success levels with the LATCH Breastfeeding Diagnostic Measurement Tool were evaluated at the beginning of the study (pretest) and after three days of breastfeeding training (posttest) before the training was given.
Before starting this study, ethics committee approval was obtained from the Clinical Research Ethics Committee of a University in northern Turkey (decision dated 28/05/2021, numbered 2021/239) and written permission from the relevant institution where the study was conducted. In addition, the purpose of the study was explained to all participants before the data collection form was applied, and written informed consent was obtained from those who volunteered to participate in the study.
- Conditions
- Breastfeeding, Intensive Care Units, Neonatal
- Being tested
- Video-assisted breastfeeding training, The hospital's routine general breastfeeding training
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted breastfeeding trainingBehavioural
Breastfeeding training was given to the experimental group for 3 days by means of the training material prepared by the training nurse of the hospital about breast milk and breastfeeding and routinely used by nurses in breast milk training in neonatal units. During the training, mothers were allowed to watch breast milk and breastfeeding training videos. On the third day after the training, feedback was received from the applications in the video regarding the knowledge and skills of the mother, and the mother's questions were answered.
The hospital's routine general breastfeeding trainingBehavioural
The control group was given the hospital's general breastfeeding training for 3 days by means of the training material prepared by the training nurse of the hospital about breast milk and breastfeeding and used routinely by nurses in breast milk training in neonatal units, and the questions of the mother were answered. The mothers in this group performed the routine breastfeeding process and no other interventions were made.
| Study group | Role | What they receive |
|---|---|---|
| Educational group | Experimental | Video-assisted breastfeeding training was given to the educational group. Receives: Behavioral: Video-assisted breastfeeding training |
| Control group | Other | Only the hospital's routine general breastfeeding training was given to the control group, and no other intervention was made. Receives: Behavioral: The hospital's routine general breastfeeding training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding self-efficacy change
As assessed by the Postpartum Breastfeeding Self-Efficacy Scale-Brief Form.The scale assesses how competent mothers feel about breastfeeding. The lowest score that can be obtained from the scale is 14, and the highest score is 70. The higher the score, the higher the breastfeeding self-efficacy.
Measured: At baseline and at the end of the 3nd day of study, breastfeeding self-efficacy was assessed
Breastfeeding success change
As assessed by the LATCH (Latch on breast, Audible swallowing, Type of nipple, Comfort bresat/nipple, Hold) Breastfeeding Diagnostic Measurement Tool. The scale consists of five evaluation criteria [L (Latch on the breast), A (Audible swallowing), T (Type of the nipple), C (Comfort breast/nipple), H (Hold)]. Each item is evaluated between 0 and 2 points. A maximum of 10 points can be obtained from the scale. As the score obtained from the scale increases, the success of breastfeeding increases.
Measured: At baseline and at the end of the 3nd day of study, breastfeeding success was assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jun 2021
- Primary completion25 Dec 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı Baltacı, Ondokuz Mayıs University
- Investigators
- Nazlı Baltacı, phD, Principal investigator, Ondokuz Mayıs UniversityEsra Tural Büyük, phD, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221463
- Sponsor's protocol ID
- 360
- Status last verified
- Feb 2022
- First submitted
- 22 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author (E.T.B.) upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-assisted Breastfeeding Education Given to Mothers of Hospitalized Newborns on Breastfeeding Self-efficacy and Breastfeeding Success: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT05221463
- Acronym / sponsor ID
- 360
- Conditions
- Breastfeeding, Intensive Care Units, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breastfeeding rates of infants in intensive care units in the world and in Turkey are undesirably low due to the conditions of infants, mothers and healthcare workers, which threatens the health of newborns in many aspects in the early and future periods. It is thought that the visual materials and tools used in breastfeeding education can be effective both in the permanence of the acquired knowledge and in the transformation of the knowledge into behavior. This study was conducted to determine the effect of video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns on breastfeeding self-efficacy and breastfeeding success.
Hypotheses Hypothesis 01: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns does not affect breastfeeding self-efficacy of mothers.
Hypothesis 1: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns increases mothers' breastfeeding self-efficacy.
Hypothesis 02: Video-assisted breast milk and breastfeeding education given to mothers of hospitalized newborns does not affect mothers' breastfeeding success.
Hypothesis 2: Video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns increases the breastfeeding success of mothers.
This research is a non-randomized quasi-experimental study in a two-group pretest-posttest design. The research was carried out in the neonatal intensive care level 2 unit of a university hospital located in the north of Turkey. In the study, mothers who met the inclusion criteria were assigned to the education group (EG) (n=44) and the control group (CG) (n=44), some mothers did not continue the education program and left the study. In this case, the study was completed with 41 mothers in EG and 43 mothers in CG. Video assisted breastfeeding training was given to the intervention group. Only the hospital's routine general breastfeeding training was given to the control group, and no other intervention was made.Breastfeeding self-efficacy with the Postpartum Breastfeeding Self-Efficacy Scale-Short Form and breastfeeding success levels with the LATCH Breastfeeding Diagnostic Measurement Tool were evaluated at the beginning of the study (pretest) and after three days of breastfeeding training (posttest).
Detailed description
Breastfeeding rates of infants in intensive care units in the world and in Turkey are undesirably low due to the conditions of infants, mothers and healthcare workers, which threatens the health of newborns in many aspects in the early and future periods. The education given to the mother by health care professionals; It has a great effect on the initiation and maintenance of breastfeeding, prevention of breast complications and successful breastfeeding. It is thought that the visual materials and tools used in breastfeeding education can be effective both in the permanence of the acquired knowledge and in the transformation of the knowledge into behavior. This study was conducted to determine the effect of video-assisted breastfeeding and breastfeeding education given to mothers of hospitalized newborns on breastfeeding self-efficacy and breastfeeding success.
This research is a non-randomized quasi-experimental study in a two-group pretest-posttest design. The research was carried out in the neonatal intensive care level 2 unit of a university hospital located in the north of Turkey.
The universe of the study consisted of mothers who were hospitalized in the neonatal intensive care unit of the hospital where the study was conducted between 01.06.2021 and 25.12.2021 and came to breastfeed. Power analysis was performed using the G*Power (v3.1.7) program to determine the number of samples.In the calculation made by assuming that the evaluations to be made between two independent groups will have a large effect (d=0.80) on the Breastfeeding Self-Efficacy Scale-Short Shape scale scores (Tokat et al. 2010), in order to obtain 80% power (1-β) at the α=0.05 level. It was determined that there should be at least 36 people in each group. Considering that there may be losses during the research process, it was planned to recruit 44 people to each group. Three of the mothers (n=44) who met the inclusion criteria and were included in the training group (EG), and one of the mothers (n=44) who were included in the control group (KG) dropped out of the study by not continuing the training program. In this case, the study was completed with 41 mothers in EG and 43 mothers in CG.
The suitability of the mothers who came to the neonatal intensive care unit to breastfeed their babies was evaluated by the researcher. The mothers who were willing and able to participate in the study were given the necessary information about the study and their written consent was obtained. The study had an intervention and a control group. The researcher first gave video-assisted breastfeeding training to the intervention group for 3 days. On the third day after the training, feedback was received from the applications in the video regarding the knowledge and skills of the mother, and the mother's questions were answered. When these trainings were completed, other eligible mothers were included in the control group. The control group was given only the hospital's routine general breastfeeding training for 3 days and the questions of the mother were answered. The mothers in this group performed the routine breastfeeding process and no other interventions were made.
First of all, sociodemographic and obstetric data of the mothers were collected by using the introductory information form, and information about the infants was obtained by the researcher from the infants' files. Breastfeeding self-efficacy with the Postpartum Breastfeeding Self-Efficacy Scale-Short Form and breastfeeding success levels with the LATCH Breastfeeding Diagnostic Measurement Tool were evaluated at the beginning of the study (pretest) and after three days of breastfeeding training (posttest) before the training was given.
Before starting this study, ethics committee approval was obtained from the Clinical Research Ethics Committee of a University in northern Turkey (decision dated 28/05/2021, numbered 2021/239) and written permission from the relevant institution where the study was conducted. In addition, the purpose of the study was explained to all participants before the data collection form was applied, and written informed consent was obtained from those who volunteered to participate in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational group | Experimental | Behavioral: Video-assisted breastfeeding trainingVideo-assisted breastfeeding training was given to the educational group. |
| Control group | Other | Behavioral: The hospital's routine general breastfeeding trainingOnly the hospital's routine general breastfeeding training was given to the control group, and no other intervention was made. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- wanting to participate
- healthy
- 18 years and older
- the baby is hospitalized and breastfed by the neonatologist is deemed appropriate
- able to read and write
Key exclusion criteria (7 listed)
- unwilling to participate
- patient
- breast-feeding not approved by the neonatologist
- having breast problems that prevent breastfeeding
- mental, cognitive, psychiatric, hearing and vision problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-assisted breastfeeding trainingBreastfeeding training was given to the experimental group for 3 days by means of the training material prepared by the training nurse of the hospital about breast milk and breastfeeding and routinely used by nurses in breast milk training in neonatal units. During the training, mothers were allowed to watch breast milk and breastfeeding training videos. On the third day after the training, feedback was received from the applications in the video regarding the knowledge and skills of the mother, and the mother's questions were answered. | Behavioural | Educational group |
| The hospital's routine general breastfeeding trainingThe control group was given the hospital's general breastfeeding training for 3 days by means of the training material prepared by the training nurse of the hospital about breast milk and breastfeeding and used routinely by nurses in breast milk training in neonatal units, and the questions of the mother were answered. The mothers in this group performed the routine breastfeeding process and no other interventions were made. | Behavioural | Control group |
Primary outcome
Breastfeeding self-efficacy change
Time frame: At baseline and at the end of the 3nd day of study, breastfeeding self-efficacy was assessed
As assessed by the Postpartum Breastfeeding Self-Efficacy Scale-Brief Form.The scale assesses how competent mothers feel about breastfeeding. The lowest score that can be obtained from the scale is 14, and the highest score is 70. The higher the score, the higher the breastfeeding self-efficacy.
Breastfeeding success change
Time frame: At baseline and at the end of the 3nd day of study, breastfeeding success was assessed
As assessed by the LATCH (Latch on breast, Audible swallowing, Type of nipple, Comfort bresat/nipple, Hold) Breastfeeding Diagnostic Measurement Tool. The scale consists of five evaluation criteria [L (Latch on the breast), A (Audible swallowing), T (Type of the nipple), C (Comfort breast/nipple), H (Hold)]. Each item is evaluated between 0 and 2 points. A maximum of 10 points can be obtained from the scale. As the score obtained from the scale increases, the success of breastfeeding increases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author (E.T.B.) upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazlı Baltacı, phD principal investigator
Ondokuz Mayıs University
Esra Tural Büyük, phD principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-assisted breastfeeding training and The hospital's routine general breastfeeding training in people with Breastfeeding and Intensive Care Units, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding self-efficacy change (time frame: At baseline and at the end of the 3nd day of study, breastfeeding self-efficacy was assessed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.