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The primary objective of this single-center, parallel-group, randomized controlled experimental study is to evaluate the effect of short film and video-based education on the intensive care unit orientation provided to parents of premature infants, specifically assessing its impact on stress levels as the primary outcome and satisfaction and level of involvement in care as secondary outcomes. Using the block randomization method, 72 parents will be assigned to three different groups ("Routine Care" n=24, "Routine Care + Short Film-based Education" n=24, "Routine Care + Video-based Education" n=24). Research Hypotheses: Primary Hypothesis: H1/1: There is a difference between the mean stress scores of parents by group. Secondary Hypotheses: H1/2: There is a difference between the mean scores of parents' participation in care according to groups. H1/3: There is a difference between the mean scores of parents' satisfaction according to groups.
The primary objective of this single-center, parallel-group, randomized controlled experimental study is to evaluate the effect of short film and video-based education on the intensive care unit orientation provided to parents of premature infants, specifically assessing its impact on stress levels as the primary outcome and satisfaction and level of involvement in care as secondary outcomes. Using the block randomization method, 72 parents will be assigned to three different groups ("Routine Care" n=24, "Routine Care + Short Film-based Education" n=24, "Routine Care + Video-based Education" n=24). Research Hypotheses: Primary Hypothesis: H1/1: There is a difference between the mean stress scores of parents by group. Secondary Hypotheses: H1/2: There is a difference between the mean scores of parents' participation in care according to groups. H1/3: There is a difference between the mean scores of parents' satisfaction according to groups. Location and Characteristics of the Research Site: The research will be conducted in the Level IVa Neonatal Intensive Care Unit (NICU), which is a tertiary referral center. The NICU has a traditional open-bay design with two sections and a total incubator capacity of 27. Nurses work in two shifts between 08:00-16:00 (day) and 16:00-08:00 (night). The nurse/baby ratio varies between 1:1 and 1:3. A family-centered, individualized developmental care approach is implemented in the unit. Research Population and Sample: The research population will consist of the parents of premature infants admitted to the neonatal intensive care unit. The sample size was calculated using a priori power analysis. The effect size of the study titled "The effect of a comprehensive support program on the stress level of mothers in a neonatal intensive care unit" was used as the basis for this study. Accordingly, the effect size was calculated as d=1.19, two-tailed hypothesis, allocation ratio n1/n2=1, type I error 0.05, and 95% power (20 parents in each group), for a total of 60 parents. Considering possible losses (drop-outs) and confounding variables in the study, the sample size was increased by 20%. Accordingly, the sample was determined to be 72 parents in total, with 24 parents in each group. Randomization and Masking: To maintain balance in the number of parents between groups, the block randomization method was chosen. Thirty-six different combinations (ABCBAC(1), AABBCC(2), ABCCBA(3) …) with a block size of 6 containing the codes A and B will be created. The combinations will be numbered from 1 to 36. Combination numbers (1-36) will be randomly generated from randomizer.org in sets of 12 numbers in random order. Each parent's assignment to an intervention group will be numbered according to the order of admission to the neonatal intensive care unit (1-72) and placed in opaque sealed envelopes. Parents will be blinded to which group they are in, and the implementing researchers will be blinded to the research hypotheses. The researchers entering and analyzing the data will be blinded to both the research hypotheses and the intervention groups. Parent Stress Scale - NICU: To assess the stress levels of parents whose babies are in the neonatal intensive care unit (NICU) due to the physical and psychosocial environment of the unit. PSS:NICU is a 5-point Likert scale consisting of three subscales and a total of 34 items. It is scored on a scale of "1 = Not stressed at all...5 = Extremely stressed." A higher scale score indicates an increase in parental stress levels. Neonatal Intensive Care Parent Satisfaction Scale (EMPATHIC-N): To assess parental satisfaction with family-centered care services. EMPATHIC-N is a 6-point Likert scale consisting of five subscales and a total of 57 items. It is scored on a scale of "1 = Definitely not the case... 6 = Definitely the case." A score below five for each item on the scale indicates dissatisfaction; as the score increases, satisfaction increases, and as the score decreases, satisfaction decreases. Pre-Implementation and Implementation Data collection forms to be used prior to the main study will be piloted with 5 parents to assess the suitability of short film and video-based education for parents. Parents in the pilot study will not be included in the main study. Parents who meet the inclusion criteria and volunteer to participate in the study will be assigned to groups using the block randomization method. Routine Care Group: Immediately after admission, parents are first welcomed in the information room. As soon as possible, they are accompanied by a nurse to see their baby in the unit. During the parents' first visit to the unit, they are introduced to their baby's general condition, treatment process, unit environment, rules, medical devices and equipment, healthcare team, basic procedures, etc. Short Film-Based Education + Routine Care Group: Immediately after admission, parents will first be welcomed in the information room. Here, parents will be shown the short film-based education for the first time. The short film will be shared with parents via a drive link and QR code, and continuous access will be provided. Video-Based Education + Routine Care Group: Immediately after admission, parents will first be welcomed in the information room. Here, parents will be shown the video-based education for the first time. The video will be shared with parents via a drive link and QR code, and they will have continuous access to it. Data Analysis The obtained data will be analyzed using statistical package software. In the analyses, the statistical significance level will be accepted as p \< 0.05. The normality of the data distribution will be evaluated using the Shapiro-Wilk test. Tests comparing the differences between means will be used, depending on whether the scale scores show a normal distribution. Descriptive statistics such as mean, standard deviation, median, minimum and maximum values, frequency, and percentages will be used. The effect size of the differences and the 95% confidence interval will also be reported. Ethical Considerations Prior to initiating the study, approval will be obtained from the clinical research ethics committee, written permission will be obtained from the hospital, and permission to use the scale will be obtained from the authors via email. All parents participating in the study will be provided with verbal and written information about the purpose, duration, method, and confidentiality of the data, and will be asked to sign an "Informed Consent Form." Participants' identity information will be kept confidential, and data will be stored only by researchers using code numbers.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
Yes
Mersin University Hospital
Mersin, Province, Turkey (Türkiye)
Start Date
February 14, 2026
Primary Completion Date
April 23, 2026
Completion Date
May 12, 2026
Last Updated
March 3, 2026
72
ESTIMATED participants
Short Film-Based Education
BEHAVIORAL
routine care
OTHER
Video-based Education
BEHAVIORAL
Lead Sponsor
Mersin University
Collaborators
Data Source & Attribution
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