- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07768527
Virtual Reality and Simulation-Based Breastfeeding Training
12. august 2026 oppdatert av: Elif DAĞLI, Cukurova University
The Effect of Virtual Reality and Simulation-Based Breastfeeding Education on Breastfeeding Efficacy, Success, and Maintenance of Breastfeeding in Mothers Experiencing Breastfeeding Problems in the Postpartum Period: A Randomized Controlled Experimental Study
The aim of this study is to determine the effect of virtual reality and simulation-based breastfeeding education given to mothers experiencing breastfeeding problems in the postpartum period on breastfeeding potency, breastfeeding success, and breastfeeding continuation.
The research is a randomized controlled experimental study.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
The study population will consist of postpartum women who apply to the Lactation Counseling Clinic of the Obstetrics and Gynecology and Pediatric Hospital.
The sample will consist of women who voluntarily participate in the study.
Data will be collected through face-to-face interviews.
Data will be collected by completing the "Personal Information Form", the "Mother's Breastfeeding Ability Scale" and the "Bristol Breastfeeding Assessment Scale".
Studietype
Intervensjonell
Registrering (Antatt)
159
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Elif DAĞLI, Associate Professor
- Telefonnummer: 146 +903223386560
- E-post: elifarik90@gmail.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Primiparous
- Infant in the neonatal period
- Over 18 years of age
- Term delivery
- Healthy baby and individual
- No communication barriers
- Willing to participate in the study
- Able to read and write Turkish
Exclusion Criteria:
- Multiparous
- Infant not in the neonatal period
- Under 18 years of age
- Premature delivery
- Unhealthy baby and individual
- No communication barriers
- Unwilling to participate in the study
- Unable to read and write Turkish
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Virtual Reality Group
Mothers in this group will receive breastfeeding training using virtual reality glasses.
|
Mothers in this group will receive breastfeeding training using wearable nursing covers and newborn baby mannequins.
Mothers in this group will receive breastfeeding training as part of routine hospital protocol.
|
|
Eksperimentell: Simulation Group
Mothers in this group will receive breastfeeding training using wearable nursing covers and newborn baby mannequins.
|
Mothers in this group will receive breastfeeding training as part of routine hospital protocol.
Mothers in this group will receive breastfeeding training using virtual reality glasses.
|
|
Aktiv komparator: Control Group
Mothers in this group will receive breastfeeding training as part of routine hospital protocol.
|
Mothers in this group will receive breastfeeding training using wearable nursing covers and newborn baby mannequins.
Mothers in this group will receive breastfeeding training using virtual reality glasses.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mother's Breastfeeding Strength Scale
Tidsramme: up to 12 months
|
This is a 37-item, 5-point Likert-type scale developed to assess mothers' breastfeeding strength level.
Scale items are scored from "1 = Strongly disagree" to "5 = Strongly agree."
There are no reverse-scored items.
The total score ranges from 37 to 185.
A higher total score indicates a higher level of breastfeeding strength in the mother.
Subscale scores are calculated by summing the items in the relevant subscale.
Higher scores indicate a more positive situation in terms of breastfeeding knowledge and skills, perceived competence, beliefs about breastfeeding, coping with breastfeeding problems, providing family support, and breastfeeding self-efficacy.
|
up to 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Bristol Breastfeeding Assessment Scale
Tidsramme: up to 12 months
|
Developed by Jenny Ingram in 2014 and adapted into Turkish by Dolgun et al. in 2017, the scale is designed to assess common breastfeeding problems and adequacy in the postpartum period.
The mother is observed by a midwife/nurse during breastfeeding, and the form is completed based on the criteria, evaluating both mother and baby.
The application time is 5-10 minutes.
While the original version of the scale had a Cronbach's Alpha of 0.68, the Turkish adaptation yielded 0.77.
In our study, the reliability coefficient was determined to be 0.87.
The measurement tool is a Likert-type scale consisting of 4 items: "positioning," "holding," "sucking," and "swallowing."
|
up to 12 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. mars 2027
Studiet fullført (Antatt)
1. april 2027
Datoer for studieregistrering
Først innsendt
12. august 2026
Først innsendt som oppfylte QC-kriteriene
12. august 2026
Først lagt ut (Faktiske)
17. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Breastfeeding success
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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