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The Effect of Video Education on Skin-to-Skin at the Time of Delivery

20 luglio 2019 aggiornato da: Catherine Caponero, Kettering Health Network

The main purpose of this study is to determine the effect of prenatal video education on pregnant women's intention to practice and actual practice of skin to skin contact (SSC) after birth. This study hypothesizes that education in video format will increase patients knowledge about skin to skin in a way that will make them consider participating in skin to skin immediately after birth.

Therefore the end point for this study is intention to participate in SCC measured by a single questionnaire item "Do you plan on participating in skin to skin (or kangaroo care) immediately after birth?" Our secondary end-point will measure whether or not the patient was able to participate in skin to skin within five minutes of delivery.

All study participants will complete a short survey about their intention of practicing skin to skin after birth upon admission for delivery. Half of the study participants will only complete the brief survey. The other half of study participants will then watch a short video about skin to skin and complete one follow up question regarding their intention to practice skin to skin at the time of delivery. All patients will be followed until after delivery to determine if they were able to participate in skin to skin after delivery.

Panoramica dello studio

Descrizione dettagliata

Despite strong support of breastfeeding by organizations such as the American Academy of Pediatrics, the American Congress of Obstetricians and Gynecologists, and the American Academy of Family Physicians, the rate of breastfeeding initiation at the time of delivery and continuation at 6 months postpartum is below the Center of Disease Prevention's Healthy People 2010 goals (1). UNICEF and the World Health Organization (WHO) have estimated that if all babies were breastfed for a minimum of the first six months of their lives, the rate of morbidity and malnutrition would significantly decrease all over the world (2). The benefits of breastfeeding are numerous for both mothers and infants, with infants obtaining optimal nutrition and passive immunity, and mothers obtaining a more rapid return of postpartum uterine tone, postpartum weight loss, delay of ovulation, and decreased risk of breast, ovarian, and endometrial cancers (3). As a result of this information, in 1991 WHO and UNICEF launched the Baby-Friendly Hospital Initiative (BFHI) to encourage proper infant feeding practices starting at birth. It is based on ten steps, which the hospital must meet and maintain to obtain certification. In support of Step Four of the BFHI to "help mothers initiate breastfeeding within one hour of birth," the skin-to-skin variation of Kangaroo Mother Care was initiated (4).

Kangaroo position, or skin to skin contact (SSC) on a mother's chest, provides thermoregulation, physiological stability, appropriate stimulation, and encourages bonding and breastfeeding (5). In fact, early SSC was significantly associated with type of feeding at discharge through 3 months postpartum (6). Regrettably, according to the American Academy of Pediatrics, some obstacles to SSC and breastfeeding include insufficient prenatal education, disruptive obstetrical practices, and a lack of family and societal support (7). Delivery room and postpartum hospital routines may also significantly disrupt early maternal-infant interactions (8). These barriers to breastfeeding and SSC are more prevalent amongst vulnerable groups, which includes low income, low educational level, and black populations. While effective initiatives such as BFHI are present in hospital settings, guidelines for primary care based interventions originating in a clinician's office currently do not exist (3). Through encouraging education regarding SSC before the time of delivery, patients can actively participate in SSC during delivery and advocate for early SSC (9).

Education can easily influence behavior habits and does not need to require special difficulties on behalf of providers (9). In fact, educational programs have the single greatest effect of any single intervention on both initiation and short term duration for breastfeeding (3). Women who attended breastfeeding classes with lactation consultants - with or without video supplementation - had significantly increased breastfeeding at six months when compared to controls (1). Currently, common office practices include provision of written materials and discharge packets. Neither practice has been shown to be effective in increasing rates of breastfeeding. On the contrary, discharge packets have been shown to reduce the rates of breastfeeding (3). Ideally, breastfeeding education would use both individual or group sessions where both benefits of breastfeeding and SSC would be discussed (10). However, in a busy clinic setting filled with a vulnerable patient population, having the ability to get to extra educational classes is not always an option.

Regardless of amount of prenatal education provided, Southview Medical Center will study participating patients at the time of admission for delivery who watch an 8 minutes 52 second patient education DVD titled "Jumping into Kangaroo Care" by the Ohio Department of Health. Of importance, studies so far have shown no clear pattern for the outcome of breastfeeding in respect to intervention timing (7). In an analysis regarding video modeling, patients who viewed videotapes regarding treatment options had a greater understanding of the risks and benefits of those choices and were more apt to be active participants in decision making (11). Audio-visual material can also be entertaining and can be used by those who have limited literacy. Moreover, the information provided to patients on video has the advantage of being repeatable and consistent, which would allow us to provide the same information to all of our patients (12). By educating patients in a video format at the beginning of their delivery admission, patients will have time to formulate questions and opinions to help them engage in an active dialogue with the staff that will be preforming the delivery. The goal of educating mothers is not only to increase their knowledge and skills but also to influence their attitudes (13). By providing a video which models SSC to all non-emergent anticipated vaginal deliveries upon admission to the hospital, the investigators' hope is to encourage patients to actively participate in SSC at the time of delivery and become their own advocates.

The main purpose of this study is to determine the effect of prenatal video education on pregnant women's intention to practice SSC after birth. This study is critical as quality measures for Southview Medical Center for quarter one of 2017 showed that the hospital has only been 50% successful at initiating skin to skin in vaginal deliveries after 37 weeks gestation with a 5 minute APGAR of 7. The hospital's goal per BFHI is 82%. The investigators' hypothesis is that 30% or more women who did not plan to use SCC would indicate their intention to use SSC post-intervention as compared to those who did not receive the intervention.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

240

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Ohio
      • Centerville, Ohio, Stati Uniti, 45459
        • Southview Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Pregnant women at Southview Medical Center
  • Over the age of 18
  • Anticipating a vaginal delivery within one week of admission to labor and delivery
  • English speaking
  • Greater than 37 weeks gestation

Exclusion Criteria:

  • Not female
  • Not pregnant
  • Less than 37 weeks gestation
  • A scheduled cesarean section
  • Unstable medical status
  • Expecting an unstable baby requiring medical resuscitation
  • Under the age of 18
  • Non-English speaking requiring translation services

If a patient has a baby with a 5 minute APGAR less than 7 at the time of delivery or needs to proceed to the operating room for cesarean delivery, the patient would not be included in data collection regarding skin to skin at the time of delivery. For this group, only intention would be measured

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Group A - no video group

Group A will be asked a short survey:

  • their intention to practice skin to skin at the time of delivery
  • if they participated in skin to skin in a previous pregnancy
  • if they had any formal education about skin to skin
  • if they did have formal education was it either

    • a.) Provided at a prenatal appointment,
    • b.) A formal class led by either a nurse or a lactation consultant.

We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).

Sperimentale: Group B - video group

Group B will be asked the same short survey as group A.

The patient would then immediately watch "Jumping into Kangaroo Care", and then immediately take the post survey which would ask if they intended to practice skin to skin at the time of delivery.

We will also look at patient's medical record number, age, gestational age, any pregnancy complications, race, type of insurance, and the number of times the patient has been pregnant. We will also examine data that is already collected by this hospital after delivery regarding skin to skin. This includes gestational age in weeks at the time of delivery, 5 minute APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to skin duration (minutes), and skin to skin duration (minutes).

The video is 8 minutes and 52 seconds in length. The video discusses the benefits and logistics of Kangaroo Care from professional's perspectives and from new mother's perspectives.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intention to Practice Skin-to-skin Contact After Birth
Lasso di tempo: 1 day

Both groups will be asked a short survey at the time of admission:

  • their intention to practice skin to skin at the time of delivery
  • if they participated in skin to skin in a previous pregnancy
  • if they had any formal education about skin to skin
  • if they did have formal education was it either

    • a.) Provided at a prenatal appointment
    • b.) A formal class led by either a nurse or a lactation consultant Group B will watch a short video about skin-to-skin contact and will be then reasked a question regarding their intention to practice skin-to-skin contact after birth. This information will allow us to determine if video education impacts the intention to practice skin-to-skin contact after birth.
1 day
Actual Practice of Skin-to-skin Contact After Birth
Lasso di tempo: 1 week
For both video and non-video groups, skin to skin duration (minutes) after delivery will be calculated. The time in minutes from delivery to initiation of skin to skin contact is also collected. This information will allow us to determine if video education impacts the actual practice of skin-to-skin contact after birth.
1 week

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Catherine M Caponero, DO, Kettering Health Network

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 giugno 2017

Completamento primario (Effettivo)

26 ottobre 2017

Completamento dello studio (Effettivo)

26 ottobre 2017

Date di iscrizione allo studio

Primo inviato

25 giugno 2017

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2017

Primo Inserito (Effettivo)

27 giugno 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 1078384-2

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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