The Effect of Video Education on Skin-to-Skin at the Time of Delivery
Phase: NA
Conditions: Kangaroo Care, Video, Prenatal Education, Skin-to-skin
Sponsor: Kettering Health Network

 
 
 
 
 
 
 
RESEARCH PROTOCOL  
 
 
 
 
 
 
 
 
TO: 
Kettering Health Network Institutional Review Board 
 
FROM: 
Principal Investigator:  Catherine Caponero 
Phone Number / Fax Number: 937-401-6850 
Email Address:  Catherine.caponero@ketteringhealth.org 
 
DATE: 
5/29/2017 
 
STUDY TITLE: The Effect of Video Education on Skin-to-Skin at the Time of Delivery 
 
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Study Summary 
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The main purpose of this study is to determine the effect of prenatal video education on 
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pregnant women’s intention to practice and actual practice of skin to skin contact (SSC) 
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after birth. 
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Purpose 
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This study hypothesizes that education in video format will increase patients knowledge 
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about skin to skin in a way that will make them consider participating in skin to skin 
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immediately after birth. Therefore our end point for this study is intention to participate in 
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SCC measured by a single questionnaire item “Do you plan on participating in skin to skin 
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(or kangaroo care) immediately after birth?”  Our secondary end-point will measure whether 
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or not the patient was able to participate in skin to skin within five minutes of delivery. 
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Background and Significance 
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Despite strong support of breastfeeding by organizations such as the American Academy of 
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Pediatrics, the American Congress of Obstetricians and Gynecologists, and the American 
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Academy of Family Physicians, the rate of breastfeeding initiation at the time of delivery and 
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continuation at 6 months postpartum is below the Center of Disease Prevention’s Healthy 
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People 2010 goals (1).  UNICEF and the World Health Organization (WHO) have estimated 
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that if all babies were breastfed for a minimum of the first six months of their lives, the rate of 
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morbidity and malnutrition would significantly decrease all over the world (2).  The benefits 
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of breastfeeding are numerous for both mothers and infants, with infants obtaining optimal 
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nutrition and passive immunity, and mothers obtaining a more rapid return of postpartum 
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uterine tone, postpartum weight loss, delay of ovulation, and decreased risk of breast, 
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ovarian, and endometrial cancers (3).  As a result of this information, in 1991 WHO and 
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UNICEF launched the Baby-Friendly Hospital Initiative (BFHI) to encourage proper infant 
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feeding practices starting at birth.  It is based on ten steps, which the hospital must meet 
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and maintain to obtain certification.  In support of Step Four of the BFHI to “help mothers 
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initiate breastfeeding within one hour of birth,” the skin-to-skin variation of Kangaroo Mother 
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Care was initiated (4). 
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Kangaroo position, or skin to skin contact (SSC) on a mother’s chest, provides 
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thermoregulation, physiological stability, appropriate stimulation, and encourages bonding 
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and breastfeeding (5).  In fact, early SSC was significantly associated with type of feeding at 
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discharge through 3 months postpartum (6). Regrettably, according to the American 
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Academy of Pediatrics, some obstacles to SSC and breastfeeding include insufficient 
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prenatal education, disruptive obstetrical practices, and a lack of family and societal support 
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(7).  Delivery room and postpartum hospital routines may also significantly disrupt early 
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maternal-infant interactions (8).  These barriers to breastfeeding and SSC are more 
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prevalent amongst vulnerable groups, which includes low income, low educational level, and 
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black populations.  While effective initiatives such as BFHI are present in hospital settings, 
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guidelines for primary care based interventions originating in a clinician's office currently do 
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not exist (3).  Through encouraging education regarding SSC in a before the time of 
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delivery, patients can actively participate in SSC during delivery and advocate for early SSC 
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(9).   
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Education can easily influence behavior habits and does not need to require special 
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difficulties on behalf of providers (9).  In fact, educational programs have the single greatest 
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effect of any single intervention on both initiation and short term duration for breastfeeding 
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(3).  Women who attended breastfeeding classes with lactation consultants - with or without 
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video supplementation - had significantly increased breastfeeding at six months when 
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compared to controls (1).  Currently, common office practices include provision of written 
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materials and discharge packets.  Neither practice has been shown to be effective in 
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increasing rates of breastfeeding.  On the contrary, discharge packets have been shown to 
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reduce the rates of breastfeeding (3).  Ideally, breastfeeding education would use both 
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individual or group sessions where both benefits of breastfeeding and SSC would be 
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discussed (10).  However, in a busy clinic setting filled with a vulnerable patient population, 
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having the ability to get to extra educational classes is not always an option. 
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Regardless of amount of prenatal education provided, Southview Medical Center will study 
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participating patients at the time of admission for delivery who watch an 8 minutes 52 
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second patient education DVD titled “Jumping into Kangaroo Care” by the Ohio Department 
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of Health.  Of importance, studies so far have shown no clear pattern for the outcome of 
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breastfeeding in respect to intervention timing (7).  In an analysis regarding video modeling, 
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patients who viewed videotapes regarding treatment options had a greater understanding of 
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the risks and benefits of those choices and were more apt to be active participants in 
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decision making (11).  Audio-visual material can also be entertaining and can be used by 
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those who have limited literacy.  Moreover, the information provided to patients on video has 
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the advantage of being repeatable and consistent, which would allow us to provide the same 
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information to all of our patients (12).  By educating our patients in a video format at the 
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beginning of their delivery admission, patients will have time to formulate questions and 
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opinions to help them engage in an active dialogue with the staff that will be preforming the 
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delivery.  The goal of educating mothers is not only to increase their knowledge and skills 
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but also to influence their attitudes (13).  By providing a video which models SSC to all non-
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emergent anticipated vaginal deliveries upon admission to the hospital, our hope is to 
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encourage patients to actively participate in SSC at the time of delivery and become their 
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own advocates.    
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The main purpose of this study is to determine the effect of prenatal video education on 
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pregnant women’s intention to practice SSC after birth. This study is critical for our hospital 
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as quality measures for Southview Medical Center for quarter one of 2017 showed that we 
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have only been 50% successful at initiating skin to skin in vaginal deliveries after 37 weeks 
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gestation with a 5 minute APGAR of 7.  Our goal as a hospital per BFHI is 82%.  Our 
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hypothesis is that 30% or more women who did not plan to use SCC would indicate their 
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intention to use SSC post-intervention as compared to those who did not receive the 
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intervention. 
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Human Subject Population   
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Method of Subject Identification 
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Patients will be recruited and consented to participate in the study at the time of admission 
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to Labor and Delivery by a resident.  In order to be asked to participate in the study, patients 
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need to be admitted with anticipation of a normal spontaneous vaginal delivery within one 
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week at the time of admission, greater than 37 weeks gestational age, and over the age of 
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18. 
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Use of PHI for Prescreening/ Recruitment (Activities Preparatory to Research) 
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☒ Check if existing records (e.g. medical records, patient logs) will be queried or 
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reviewed to identify or prescreen potential participants and no HIPAA waiver will be 
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requested.  By checking, investigator attests to the following: 
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• PHI will be collected or obtained (reviewed) only for recruitment/ prescreening 
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purposes.  PHI collected will be stored confidentially and will be destroyed per 
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KHN standards as soon as no longer necessary for the research. 
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• The requested use or disclosure under this section is solely to review patient 
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information / PHI as necessary for purposes preparatory to research (e.g. to 
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identify or prescreen potential participants for recruiting purposes). 
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• The PHI will not be removed from KHN in the course of the review. 
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• The PHI for which use or access is requested is necessary for the research. 
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Recruitment / prescreening activities will be stopped by specify date. 
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PHI from ☒ ≥ 50 ☐ < 50 patients will be accessed for prescreening / recruitment 
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activities.  If PHI from < 50 patients will be accessed, specify who will track HIPAA 
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disclosures.  
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Method of Recruitment 
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Patients will be recruited and consented to participate in the study at the time of admission 
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to Labor and Delivery a resident. 
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Data / Tissue Sources or Repositories  
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Epic records will be accessed to obtain information pertinent to the study 
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Subject Payments 
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N/A 
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Gender of Subjects   Females Only 
 
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Number of Subjects 
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Up to 240 subjects may participate at KHN.     
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Age Range of Participants 
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Over the age of 18 
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Inclusion/Exclusion Criteria 
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Inclusion Criteria 
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Pregnant women at Southview Medical Center 
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Over the age of 18 
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Anticipating a vaginal delivery within one week of admission to labor and delivery 
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English speaking 
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Greater than 37 weeks gestation 
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Exclusion Criteria 
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Not female 
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Not pregnant 
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Less than 37 weeks gestation 
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A scheduled cesarean section 
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Unstable medical status 
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Expecting an unstable baby requiring medical resuscitation 
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Under the age of 18 
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Non-English speaking requiring translation services 
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Vulnerable Subjects 
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Pregnant women may be considered vulnerable subjects.  Teach back method during the 
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consent process will be used to ensure understanding regarding participation.  This study 
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poses no medical risks to pregnant women, fetuses, or neonates.  Any pregnant woman 
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appearing to be in a cognitive or emotional state that would prevent informed consent would 
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be excluded. 
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Research Design and Methods 
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If participating in the study in the experimental group the patient would watch the video prior to 
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delivery.   
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A sample size of 240 (120+120) will participate in this randomized control trial.  Alternate 
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patients will be randomized at the time of admission into no video (Group A) and video groups 
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(Group B).  120 patients will be in Group A.  120 patients will be in Group B. 
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Randomization will occur in the order that they get enrolled into the study.  If an eligible patient 
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wishes to participate in the study, the resident obtaining consent will consult the list of patients 
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to determine if that particular patient will be in Group A or Group B.  The first patient enrolled 
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would be in Group A and asked a pre-survey regarding: 
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their intention to practice skin to skin at the time of delivery 
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if they participated in skin to skin in a previous pregnancy 
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if they had any formal education about skin to skin 
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if they did have formal education was it either  
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o a.) Provided at a prenatal appointment,  
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o b.) A formal class led by either a nurse or a lactation consultant.    
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The second patient enrolled would be in Group B and take the same pre-survey, immediately 
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watch “Jumping into Kangaroo Care”, and then immediately take the post survey which would 
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ask if they intended to practice skin to skin at the time of delivery.  The third patient enrolled 
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would take only the pre-survey and be in Group A, etc.   
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The video the patients will watch is titled “Jumping into Kangaroo Care” by the Ohio Department 
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of Health.  The video is 8 minutes and 52 seconds in length.  The video discusses the benefits 
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and logistics of Kangaroo Care from professional’s perspectives and from new mother’s 
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perspectives.  By having patients watch this video before the time of delivery, we can see if 
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patients intend to participate in skin to skin, regardless of their previous education.   
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In this study, we will examine patient’s medical record number, age, gestational age, any 
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pregnancy complications, race, type of insurance, and the number of times the patient has been 
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pregnant.  We will also examine data that is already collected by this hospital after delivery 
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regarding skin to skin.  This includes gestational age in weeks at the time of delivery, 5 minute 
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APGAR, delivery date/time, skin to skin initiation time, skin to skin end time, delivery to skin to 
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skin duration (minutes), and skin to skin duration (minutes).  We will also examine if skin to skin 
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is not initated for patient acuity, maternal acuity, or if the patient refused. 
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If a patient has a baby with a 5 minute APGAR less than 7 at the time of delivery or needs to 
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proceed to the operating room for cesarean delivery, the patient would not be included in data 
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collection regarding skin to skin at the time of delivery.  For this group, only intention would be 
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measured 
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Surveys / Interviews / Questionnaires 
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Ob/gyn residents at Southview Medical Center will ask the survey questions.  The survey will be 
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asked in the patient’s labor room at the hospital once they are admitted.  The survey will be 
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administered one-on-one.  A copy of the survey has been attached.  They will then watch 
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“Jumping into Kangaroo Care” by the Ohio Department of Health if they are in the experimental 
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group.  Copyright has been attached. 
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Risks / Discomforts 
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Physical risks or discomforts  
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No known risks 
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Psychological risks or discomforts  
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No known risks 
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Social risks or harms  
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Breach of confidentiality  
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Economic risks  
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No known risks 
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Legal risks  
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No known risks 
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Procedures to Minimize Risks (describe for each risk listed above) 
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Breaches of confidentiality: see Data Storage and Confidentiality section 
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Specify who will evaluate adverse events / serious adverse events (AEs / SAEs) to identify 
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and report unanticipated problems: Catherine Caponero, DO 
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Diagnostic/treatment (non-research) procedures to be used for the study 
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N/A 
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Benefits 
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Potential benefits to participants 
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Participants may benefit by learning the benefits of skin to skin care after delivery. 
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Potential benefits to others / contributions to knowledge 
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Others can benefit by learning if video education video education can positively contribute to 
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patients intent and compliance with skin to skin at the time of delivery  
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Data Analysis  
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Preliminary data on both primiparous and multiparous women from our records indicate that 
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compliance with skin-to-skin is about 50%. We hypothesize that a 30% improvement in intention 
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along with compliance with SCC is attainable with video education. We also have the ability to 
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recruit 120 eligible women per group (240 in total) into the study. Using z test for two 
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proportions, 90% power with alpha of 0.05, two-tailed, we will need about 53 patients per arm 
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(106 in total) based on assumption that 50% of no formal education group and 80% of video 
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education group would indicate their intention to participate, and hopefully participate in SCC 
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post intervention. 
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We will employ interim analysis, based on potentially recruiting 240 patients, and adopt “two 
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looks”; one at the time when 120 (60 per group) women would be recruited and the other when 
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240 (120 per group) women would be recruited.  We will use cut-off points of z=3.5 for first look 
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and z=2.0 for second look, as suggested by O’Brien-Fleming (1979), as decision rules to stop or 
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continue data collection. If calculated z statistics is greater than 3.5 during first interim analysis, 
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we will stop data collection. If calculated z-statistics is less than 3.5, we will continue data 
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collection and reject the null during final analysis only when calculated z-statistics is greater 
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than 2.0. 
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Assuming 50% and 80% intention levels (30% difference in proportion) during first interim 
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analysis, 50% interim sample size (120 patients) would result in absolute z- statistics of 4.89 to 
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stop data collection. 
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If data collection continues due to proportion difference less than 30%, sample size of 240 
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during final analysis would produce absolute z-statistics of 2.20 to reject the null hypothesis 
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based on assumption of 10% difference in end-point. 
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Mean (Standard deviation) and sample size (percentage) will be used to summarize normally 
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distributed continuous data and categorical data respectively. Either t-test of independence or 
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Chi-square test of independence will be used to test if significant differences exist between two 
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groups on quantitative data or on categorical data respectively, at alpha of 0.05, two tailed. Z-
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test of two proportions would be used to test if significant differences exist between two groups. 
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Logistic regression would be used in order to account for other variables if necessary. SPSS 
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version 22 will be used to analyze data.  Dr. Heh, associated with Ohio University, will act as our 
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statistician and help us to analyze our data.  
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Data Monitoring to Ensure Safety of Subjects 
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☒ Check if this study involves treatment or intervention and provide narrative of plan to 
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monitor data to ensure safety of subjects below: 
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The video intervention involves minimal risk. 
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Privacy Protections 
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We will collect coded data to ensure patient’s privacy.  We will also recruit and consent in 
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patient’s private rooms on labor and delivery. 
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Data Storage and Confidentiality 
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Check all of the following which will be used to access (review), collect, receive, and/or 
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transmit study information: 
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☒  Email   ☐  Camera/Camera Phone ☐  Portable media (flash drive, CD/DVD, hard drive, etc.)     
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☒  Laptop ☐  Wireless Device     
☒  Internet data access/data entry 
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☒  Paper   ☒  KHN Workstation    
☐  Non-KHN computer    
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☐  Other (specify): Click here to enter text. 
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Describe where data/ records/ samples will be stored and how they will be kept secure: 
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Data will be stored in two binders on labor and delivery at the resident work station.  Only 
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approved ob/gyn residents will have access to the study binders.  One binder will have the 
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patient’s name and enumber along with a number assigned to each patient.  The other 
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binder will have the surveys with each survey having the number assigned to each patient. 
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Any email communication with PHI will be KHN only.  If outside KHN email is needed it will 
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be encrypted.  Internet data access will be through Epic.  All electronic records will be stored 
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on the resident KHN workstation on L&D that is password protected and only accessable by 
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the PI.   
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Specify who will have access to study information/ to whom it will be released (if applicable): 
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Ob/gyn residents approved to participate in this study will have access to the study 
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information as they will help with the data collection 
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Describe plans for storage, destruction, and/or return of study data and records after closure: 
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Study records will be stored with Dr. Moussa and locked in her office at Kettering Hospital.  
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Paper records will be destroyed six years after closure of the study due to HIPAA 
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documentation being required.  Paper records will be placed in confidential shredder bin for 
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destruction.  Electronic records will be stored on Dr. Moussa’s KHN workstation and 
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permenantly deleted after six years.  
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☐  Check if data or specimens will be saved or stored for future use and provide details: 
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Click here to enter text. 
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Estimated Period of Time to Complete the Study (after IRB Approval) 
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Recruitment/data collection/active participation: June 2017-December 2017 
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Follow up: N/A 
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Data analysis/write-up: January 2018 
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Consenting Process and Location(s) 
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Initial consenting process 
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The principal investigator and fellow ob/gyn residents will be involved in consenting of the 
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subjects.  The consent will take place in private labor rooms on labor and delivery.  The 
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consenting process is expected to take five to ten minutes. 
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Consenting process after first visit 
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N/A 
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Documentation of consent (check all that apply): 
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☒ Subjects’ written, signed consent will be obtained. 
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☐ Waiver of consent is requested (attach Consent Form – Application for Waiver*) 
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(Information is collected without subject knowledge: e.g. chart reviews) 
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☐ Waiver of a signed consent is requested (attach Consent Form – Application for Waiver*) 
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(Individuals participate directly but do not sign a consent form: e.g. anonymous surveys) 
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☐ Alteration of consent is requested (attach Consent Form – Application for Waiver*) 
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(Consent to be signed is not accurate or complete: e.g. study involving deception) 
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*for non-exempt submissions 
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Grant Application 
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N/A 
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Study Budget: Funding, Resources, and Expenses 
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Resources needed  
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Paper, binders, and video 
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Expenses to be incurred  
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Institutional Review Board administrative and review expenses 
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Funding and sources of funds 
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N/A 
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References 
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1. Rosen IM, Krueger MV, Carney LM, Graham JA. Prenatal breastfeeding education and 
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breastfeeding outcomes. MCN Am J Matern Child Nurs. 2008;33(5):315-9. 
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2. Burgio MA, Laganà AS, Sicilia A, et al. Breastfeeding Education: Where Are We Going? 
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A Systematic Review Article. Iran J Public Health. 2016;45(8):970-977. 
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3. Guise JM, Palda V, Westhoff C, Chan BK, Helfand M, Lieu TA. The effectiveness of 
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primary care-based interventions to promote breastfeeding: systematic evidence review and 
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meta-analysis for the US Preventive Services Task Force. Ann Fam Med 2003;1:70–8. 
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4. Baby-Friendly USA. “Guidelines and Evaluation Criteria for Facilities Seeking Baby-
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Friendly Designation.” Albany, NY: Baby-Friendly USA. 2016. 
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5. Charpak N, Ruiz JG. The Kangaroo Mother Care Method: from scientific evidence 
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generated in Colombia to worldwide practice. J Clin Epidemiol. 2016. 
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6. Vila-candel R, Duke K, Soriano-vidal FJ, Castro-sánchez E. Effect of Early Skin-to-Skin 
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Mother-Infant Contact in the Maintenance of Exclusive Breastfeeding. J Hum Lact. 2017. 
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7. Chung M, Raman G, Trikalinos T, Lau J, Ip S. Interventions in Primary Care to Promote 
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Breastfeeding: An Evidence Review for the U.S. Preventive Services Task Force. Ann Intern 
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Med. 2008;149:565-582.  
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8. Moore ER, Anderson GC, Bergman N. Early skin-to-skin contact for mothers and their 
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healthy newborn infants. Cochrane Database Syst Rev. 2007;(3):CD003519. 
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9. Martínez-galiano JM, Delgado-rodríguez M. Influence of an education program of 
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pregnant women on delivery. J Matern Fetal Neonatal Med. 2014;27(7):719-23 
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10. Guise JM, Palda V, Westhoff C, Chan B, Helfand M, Lieu TA. The effectiveness of 
339 
primary care-based interventions to promote breastfeeding: systematic evidence review and 
340 
meta-analysis for the US Preventive Services Task Force. Ann Fam Med 3002;1:70-78. 
341 
11. Krouse, H. J. Video modelling to educate patients. Journal of Advanced Nursing. 2001; 
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33: 748–757.  
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12. Abu abed M, Himmel W, Vormfelde S, Koschack J. Video-assisted patient education to 
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modify behavior: a systematic review. Patient Educ Couns. 2014;97(1):16-22. 
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13. Shealy KR, Li R, Benton-Davis S, Grummer-Strawn LM. The CDC Guide to 
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Breastfeeding Interventions. Atlanta: U.S. Department of Health and Human Services, 
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Centers for Disease Control and Prevention, 2005. 
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14. O’Brien, P.C.; Fleming, T.R. (1979). "A Multiple Testing Procedure for Clinical Trials". 
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Biometrics. 35: 549–556. 
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