- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04929561
The Effect of Breastfeeding Support Provided Via Video-conferencing
15. juni 2021 opdateret af: Deniz Akyıldız, Kahramanmaras Sutcu Imam University
The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial
A randomized control trial was made to examine the effects of breastfeeding support given by the video-conferencing method in the early postpartum period on anxiety, breastfeeding self-efficiency, and newborn outcomes.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
78
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Deniz Akyıldız, PhD
- Telefonnummer: 05069851358
- E-mail: denizbtm@gmail.com
Undersøgelse Kontakt Backup
- Navn: Deniz Akyıldız
- Telefonnummer: 05069851358
- E-mail: denizbtm@gmail.com
Studiesteder
-
-
Kahramanmaraş
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Kahramanmaras, Kahramanmaraş, Kalkun, 4600
- Rekruttering
- Kahramanmaraş Sütçü İmam University
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Kontakt:
- Deniz Akyıldız
- Telefonnummer: 05069851358
- E-mail: denizbtm@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Infants;
- Born between 37 and 42 weeks
- Without severe congenital anomalies
Mothers;
- A single live birth
- Were 18 years of age or over
- At least primary school graduate
- Did not have a disease that prevents breastfeeding
- Had internet access at home or on the phone
- Could speak and understand the Turkish language.
Exclusion Criteria:
- Situations that cause separation of mother and baby
- Hospitalization of the baby in intensive care
- Inability to answer 3 calls in a video call
- They were determined as those who could not be reached during the home visit for the first and second follow
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Video-conferencing group
The mothers in the video-conferencing group were counseled via video-conferencing a total of six times (three times a week, at equal intervals) during the first 2 weeks after birth.
Each interview was approximately 15-20 minutes.
In video-conferencing sessions, the breastfeeding position, the mother's grasping the breast, the baby's latch-on, and sucking duration were observed.
Mothers' questions were answered and solutions were offered for breastfeeding problems (sore nipple, engorgement, etc.).
|
No intervention
Andre navne:
|
|
Ingen indgriben: Control group
The mothers in the control group were given usual care before discharge and no intervention was made after discharge.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The mean postpartum maternal anxiety level (mean ± SD)
Tidsramme: at 2 weeks and 4 weeks after delivery
|
The primary outcome of this study was the mean postpartum maternal anxiety level (mean ± SD) of the mothers at 2 weeks and 4 weeks after delivery.
Maternal anxiety level was assessed using the Postpartum Specific Anxiety Scale.
The scale comprises 51 items and 4 sub-dimensions.
It means that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level of anxiety.
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at 2 weeks and 4 weeks after delivery
|
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The mean breastfeeding self-efficacy level
Tidsramme: at 2 weeks and 4 weeks after delivery
|
The other main outcome of the study was the mean breastfeeding self-efficacy level (mean ± SD) measured with the Breastfeeding Self-Efficacy Scale Short Form.
The scale is likert type and a total score between 14 and 70 is taken from the scale.
The higher the score, the higher the breastfeeding self-efficacy.
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at 2 weeks and 4 weeks after delivery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neonatal outcomes-Newborn weight (g)
Tidsramme: at 2 weeks and 4 weeks after delivery
|
Newborn weight (g) was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
|
at 2 weeks and 4 weeks after delivery
|
|
Neonatal outcomes-Hypoglycemia of the newborn
Tidsramme: at 2 weeks and 4 weeks after delivery
|
Hypoglycemia of the newborn was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery.
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at 2 weeks and 4 weeks after delivery
|
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Neonatal outcomes-Need for phototherapy
Tidsramme: at 2 weeks and 4 weeks after delivery
|
The need for phototherapy was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
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at 2 weeks and 4 weeks after delivery
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Neonatal outcomes-Respiratory morbidity
Tidsramme: at 2 weeks and 4 weeks after delivery
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Respiratory morbidity was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
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at 2 weeks and 4 weeks after delivery
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Neonatal outcomes-illness requiring hospitalization
Tidsramme: at 2 weeks and 4 weeks after delivery
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Illness requiring hospitalization was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
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at 2 weeks and 4 weeks after delivery
|
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Neonatal outcomes-Food intake other than breast milk
Tidsramme: at 2 weeks and 4 weeks after delivery
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Food intake other than breast milk was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
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at 2 weeks and 4 weeks after delivery
|
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Neonatal outcomes-Neonatal death
Tidsramme: at 2 weeks and 4 weeks after delivery
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Neonatal death was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
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at 2 weeks and 4 weeks after delivery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Betül Bay, Kahramanmaraş Sütçü İmam University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. august 2020
Primær færdiggørelse (Forventet)
30. september 2021
Studieafslutning (Forventet)
30. september 2021
Datoer for studieregistrering
Først indsendt
7. juni 2021
Først indsendt, der opfyldte QC-kriterier
15. juni 2021
Først opslået (Faktiske)
18. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2021
Sidst verificeret
1. juni 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Breastfeeding Support
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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