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Parental StressNCT07410923

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

A study testing Short Film-Based Education, routine care and Video-based Education in people with Parental Stress and Parental Satisfaction, run by Mersin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Short Film-Based Education, routine care and Video-based Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Feb 2026to 28 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mersin University Hospital

    Mersin, Province, 33343

Other trials in Turkey (Türkiye)

About this study

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:

Read more

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.

Read the 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.

Being tested
Short Film-Based Education, routine care, Video-based Education
Keywords
premature infants, parental stress, parental satisfaction, care participation, family centered care
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short Film-Based EducationBehavioural

    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

  • routine careOther

    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.

  • Video-based EducationBehavioural

    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.

Study groups in NCT07410923
Study groupRoleWhat they receive
Routine CareActive comparatorverbal 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
Receives: Other: routine care
Short Film-Based EducationExperimentalShort 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
Receives: Behavioral: Short Film-Based Education
Video-Based EducationExperimentalVideo-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
Receives: Behavioral: Video-based Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: The baby's admission to the neonatal intensive care unit within 48-72 hours

  2. 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.

    Measured: The seventh to tenth days of the baby's admission to the neonatal intensive care unit

Secondary outcomes (4)
  1. 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.

    Measured: The baby's admission to the neonatal intensive care unit within 48-72 hours

  2. 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.

    Measured: The seventh to tenth days of the baby's admission to the neonatal intensive care unit

  3. 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.

    Measured: The baby's admission to the neonatal intensive care unit within 48-72 hours

  4. 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.

    Measured: The seventh to tenth days of the baby's admission to the neonatal intensive care unit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start14 Feb 2026
  3. Primary completion28 Apr 2026
  4. Study completion28 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07410923
Sponsor's protocol ID
MersinU*GUGUCU_006
Status last verified
Apr 2026
First submitted
7 Feb 2026
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • Latour JM, Duivenvoorden HJ, Hazelzet JA, van Goudoever JB. Development and validation of a neonatal intensive care parent satisfaction instrument. Pediatr Crit Care Med. 2012 Sep;13(5):554-9. doi: 10.1097/PCC.0b013e318238b80a.

    PubMed 22460771
  • Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.

    PubMed 8506163
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Short Film-Based Education, routine care and Video-based Education in people with Parental Stress and Parental Satisfaction, run by Mersin University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parental Stress Levels at T0 (time frame: The baby's admission to the neonatal intensive care unit within 48-72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07410923, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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