Cesarean Section; DehiscenceNCT06256822
Technology-Based Breastfeeding Training After Cesarean
An observational study of Cesarean Section; Dehiscence and Breast Feeding, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study was to determine the effect of breastfeeding training given with virtual reality (VR) to postpartum primiparous mothers on breastfeeding success and breastfeeding self-efficacy. Method: The research was designed as a prospective randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Dehiscence, Breast Feeding, Self Efficacy
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Oct 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: mothers who gave birth with cesarean section
Who may be able to join
- The study included mothers who gave birth with cesarean section, received breastfeeding counseling during pregnancy, with no vision or hearing disabilities and without any neurological disorder.
Who cannot join
- Mothers who did not give birth by cesarean section, did not receive breastfeeding counseling during pregnancy, had visual or hearing impairment, or had any neurological disease were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Technology-Based Breastfeeding Training After Cesarean on Breastfeeding Success and Self-Efficacy of Mothers
Aim: The aim of this study was to determine the effect of breastfeeding training given with virtual reality (VR) to postpartum primiparous mothers on breastfeeding success and breastfeeding self-efficacy.
Method: The research was designed as a prospective randomized controlled study. In total, 66 women were included in the study, with 31 in the control group and 35 in the intervention group. The intervention group watched a breastfeeding video with VR in the 4th and 24th hours after cesarean. Research data were collected with the sociodemographic information form, LATCH Breastfeeding Charting System and Documentation Tool and the Breastfeeding Self-Efficacy Scale. The study included mothers who gave birth with cesarean section, received breastfeeding counseling during pregnancy, with no vision or hearing disabilities and without any neurological disorder.
- Conditions
- Cesarean Section; Dehiscence, Breast Feeding, Self Efficacy
- Keywords
- breastfeeding success, cesarean, education technology, breastfeeding self-efficacy, virtual reality
- Medical subject headings
- Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Diagnostic and Assessment Scale
The Latch Breastfeeding Scale was developed by Jensen and Wallace (1993) to objectively diagnose breastfeeding, detect breastfeeding problems, plan breastfeeding education, and create the same language for health professionals. The Cronbach's alpha coefficient of the scale was found to be 0.93. The scale, adapted into Turkish by Yenal and Okumuş (2003), consists of five evaluation steps. LATCH stands for the English expressions of these steps. These evaluation steps are: ''L= Latch on breast'', ''A= Observation of the baby's swallowing movement (Audibleswallowing)'', ''T= Type of nipple'', ''C = The mother's comfort regarding the breast and nipple (Comfort breast/nipple)'', ''H = Holding position of the baby (Hold)''. Items on the scale are scored as 0-1-2. The highest score that can be obtained from the scale is 10 and the lowest score is 0. The Cronbach's alpha coefficient of the scale was found to be 0.95.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 66 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mevlüde Alpaslan Arar, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256822
- Sponsor's protocol ID
- september4
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kilic U, Arar M, Oruc MA. The effect of virtual reality on the breastfeeding process: a randomized controlled study. J Perinatol. 2024 Nov;44(11):1611-1616. doi: 10.1038/s41372-024-02077-0. Epub 2024 Jul 31.
PubMed 39085438
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Technology-Based Breastfeeding Training After Cesarean on Breastfeeding Success and Self-Efficacy of Mothers
- ClinicalTrials.gov ID
- NCT06256822
- Acronym / sponsor ID
- september4
- Conditions
- Cesarean Section; Dehiscence, Breast Feeding, Self Efficacy
- Keywords
- breastfeeding success, cesarean, education technology, breastfeeding self-efficacy, virtual reality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 13 Feb 2024 (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.
Aim: The aim of this study was to determine the effect of breastfeeding training given with virtual reality (VR) to postpartum primiparous mothers on breastfeeding success and breastfeeding self-efficacy.
Method: The research was designed as a prospective randomized controlled study. In total, 66 women were included in the study, with 31 in the control group and 35 in the intervention group. The intervention group watched a breastfeeding video with VR in the 4th and 24th hours after cesarean. Research data were collected with the sociodemographic information form, LATCH Breastfeeding Charting System and Documentation Tool and the Breastfeeding Self-Efficacy Scale. The study included mothers who gave birth with cesarean section, received breastfeeding counseling during pregnancy, with no vision or hearing disabilities and without any neurological disorder.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- mothers who gave birth with cesarean section
Key inclusion criteria (1 listed)
- The study included mothers who gave birth with cesarean section, received breastfeeding counseling during pregnancy, with no vision or hearing disabilities and without any neurological disorder.
Key exclusion criteria (1 listed)
- Mothers who did not give birth by cesarean section, did not receive breastfeeding counseling during pregnancy, had visual or hearing impairment, or had any neurological disease were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breastfeeding Diagnostic and Assessment Scale
Time frame: 6 months
The Latch Breastfeeding Scale was developed by Jensen and Wallace (1993) to objectively diagnose breastfeeding, detect breastfeeding problems, plan breastfeeding education, and create the same language for health professionals. The Cronbach's alpha coefficient of the scale was found to be 0.93. The scale, adapted into Turkish by Yenal and Okumuş (2003), consists of five evaluation steps. LATCH stands for the English expressions of these steps. These evaluation steps are: ''L= Latch on breast'', ''A= Observation of the baby's swallowing movement (Audibleswallowing)'', ''T= Type of nipple'', ''C = The mother's comfort regarding the breast and nipple (Comfort breast/nipple)'', ''H = Holding position of the baby (Hold)''. Items on the scale are scored as 0-1-2. The highest score that can be obtained from the scale is 10 and the lowest score is 0. The Cronbach's alpha coefficient of the scale was found to be 0.95.
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 13 Feb 2024.
- Derived from this study: PubMed 39085438Kilic U, Arar M, Oruc MA. The effect of virtual reality on the breastfeeding process: a randomized controlled study. J Perinatol. 2024 Nov;44(11):1611-1616. doi: 10.1038/s41372-024-02077-0. Epub 2024 Jul 31.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section; Dehiscence and Breast Feeding, run by Ordu 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 1 inclusion and 1 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 13 Feb 2024. 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 Diagnostic and Assessment Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06256822, which also lists 1 linked publication.
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 13 Feb 2024.