The Effect of Short Film and Video-Based Education on the Intensive Care Unit Introduction for Parents of Premature Infants on Stress, Care Participation, and Satisfaction Levels

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.

Study Overview

• Status: Completed
• Conditions: Parental Stress; Parental Satisfaction; Care Participation
• Intervention / Treatment: Other: routine care; Behavioral: Short Film-Based Education; Behavioral: Video-based Education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Province
    • Mersin, Province, Turkey (Türkiye), 33343
      • Mersin University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ability to use a smartphone
• Access to the internet
• Willingness to participate in the study
• Gestational age of the baby is less than 37 weeks
• The baby has been newly admitted to the neonatal intensive care unit
• The baby is expected to remain in the unit for at least another week
• The baby's general condition is stable

Exclusion Criteria:

• Having intellectual limitations
• Having a mental health issue
• Having a baby with a major congenital anomaly or defect
• Having a baby in the terminal stage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine Care; verbal information about baby's general condition, treatment process, unit environment, rules, medical equipment and devices, healthcare team, basic procedures, etc. + showing and introducing the baby and the NICU environment	Other: routine care; 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 parent's first visit to the unit, they are introduced to their baby's general condition, treatment process, unit environment, rules, medical equipment and devices, healthcare team, basic procedures, etc.
Experimental: Short Film-Based Education; Short Film-Based Education + verbal information about baby's general condition, treatment process, unit environment, rules, medical equipment and devices, healthcare team, basic procedures, etc. + showing and introducing the baby and the NICU environment	Behavioral: Short Film-Based Education; Short Film-Based Education: 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, ensuring they have continuous access to it. This will allow parents to review the information at home or in the waiting area. + routine care
Experimental: Video-Based Education; Video-Based Education + verbal information about baby's general condition, treatment process, unit environment, rules, medical equipment and devices, healthcare team, basic procedures, etc. + showing and introducing the baby and the NICU environment	Behavioral: Video-based Education; 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, ensuring they have continuous access to it. This will allow parents to review the information at home or in the waiting area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Stress Levels at T0	PSS:NICU is a 5-point Likert scale consisting of three dimensions and a total of 34 items. The dimensions are "Visual and Auditory Stimuli (6 items)" in the unit, the baby's "Appearance and Behavior (17 items)", and the parent's "Relationship and Roles (11 items)". It is scored on a scale of "1 = Not at all stressed...5 = Extremely stressed." A higher scale score indicates an increase in parental stress levels.	The baby's admission to the neonatal intensive care unit within 48-72 hours
Parental Stress Levels at T1	PSS:NICU is a 5-point Likert scale consisting of three dimensions and a total of 34 items. The dimensions are "Visual and Auditory Stimuli (6 items)" in the unit, the baby's "Appearance and Behavior (17 items)", and the parent's "Relationship and Roles (11 items)". It is scored on a scale of "1 = Not at all stressed...5 = Extremely stressed." A higher scale score indicates an increase in parental stress levels.	The seventh to tenth days of the baby's admission to the neonatal intensive care unit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation in Care by EMPATHIC-N at T0	Participation in Care will be assessed using the EMPATHIC-N scale's parent involvement subscale (items 30-37). It is scored on a scale of "1 = Definitely not the case... 6 = Definitely the case." Scores below five on each item of the scale indicate dissatisfaction; as scores increase, satisfaction increases, and as scores decrease, satisfaction decreases.	The baby's admission to the neonatal intensive care unit within 48-72 hours
Participation in Care by EMPATHIC-N at T1	Participation in Care will be assessed using the EMPATHIC-N scale's parent involvement subscale (items 30-37). It is scored on a scale of "1 = Definitely not the case... 6 = Definitely the case." Scores below five on each item of the scale indicate dissatisfaction; as scores increase, satisfaction increases, and as scores decrease, satisfaction decreases.	The seventh to tenth days of the baby's admission to the neonatal intensive care unit
Parental Satisfaction at T0	Parental Satisfaction will be assessed using the EMPATHIC-N scale's parent involvement subscale (items 30-37). The EMPATHIC-N is a 6-item Likert scale consisting of five subscales and a total of 57 items. The subscales are "Information" (items 1-12), "Care and Treatment" (items 13-29), "Parental Involvement" (items 30-37), 'Organization' (items 38-45), and "Professional Attitude" (items 46-57). 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, with satisfaction increasing as the score increases and decreasing as the score decreases.	The baby's admission to the neonatal intensive care unit within 48-72 hours
Parental Satisfaction at T1	Parental Satisfaction will be assessed using the EMPATHIC-N scale's parent involvement subscale (items 30-37). The EMPATHIC-N is a 6-item Likert scale consisting of five subscales and a total of 57 items. The subscales are "Information" (items 1-12), "Care and Treatment" (items 13-29), "Parental Involvement" (items 30-37), 'Organization' (items 38-45), and "Professional Attitude" (items 46-57). 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, with satisfaction increasing as the score increases and decreasing as the score decreases.	The seventh to tenth days of the baby's admission to the neonatal intensive care unit

Collaborators and Investigators

• Sponsor: Mersin University
• Collaborators: Tarsus University

Publications and helpful links

General Publications

• Latour, J. M., Duivenvoorden, H. J., Hazelzet, J. A., & van Goudoever, J. B. (2012). Development and validation of a neonatal intensive care parent satisfaction instrument. Pediatric Critical Care Medicine, 13(5), 554-559.
• Miles, M. S., Funk, S. G., & Carlson, J. (1993). Parental Stressor Scale: neonatal intensive care unit. Nursing research, 42(3), 148-152.
• Goral, E., & Geçkil, E. (2021). The effect of a comprehensive support program on the stress level of mothers in a neonatal intensive care unit. Nursing Practice Today.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2026
• Primary Completion (Actual): April 28, 2026
• Study Completion (Actual): April 28, 2026

Study Registration Dates

• First Submitted: February 7, 2026
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: premature infants; parental satisfaction; parental stress; family centered care; care participation
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: MersinU*GUGUCU_006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No