NCT06359288

Brief Summary

The aim of this study was to evaluate the effect of QR code supported infant care training given to mothers of preterm newborns on maternal self-efficacy and maternal anxiety level .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

April 2, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

Motherhood Self-EfficacyAnxietyNursing CarePretermQR code

Outcome Measures

Primary Outcomes (1)

  • Perceived Maternal Self-Efficacy Scale (PMES)- Survey

    QR code-supported education given to mothers of preterm newborns improves. The scale assesses the perceived maternal self-efficacy levels of mothers of hospitalised preterm infants. The scale, which consisted of 19 items, was graded between 1 and 4 (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Scoring of the scale was calculated by adding the obtained scores. The score obtained from the scale is between 19 and 76. A high score indicates that the mother's self-efficacy is high. The reliability coefficient of the scale in mothers of hospitalised preterm infants was 0.98. In this study, the internal consistency coefficient of the scale was found to be 0.95.

    Before the recruit pre-test (PMES- survey scale) will be applied. One months after the intervention post-test (PMES survey scale) again will be applied.

Secondary Outcomes (1)

  • State-Trait Anxiety Inventory (STAI)- Survey Scale

    Before the recruit pre-test (STAI- survey scale) will be applied. One months after the intervention post-test (STAI survey scale) again will be applied.

Study Arms (2)

Group receiving QR code supported training

EXPERIMENTAL

Training sessions in the training class run three days a week for two weeks. 6. During the training process, QR codes were integrated into the sections related to the care of the newborn in the guide in order to provide mothers with the opportunity to watch the video simultaneously while reading the guide in practices requiring skills related to hygienic care of the newborn and nutrition / communication / sleep, and to allow them to watch it repeatedly as long as they feel the need. In these videos, the application steps were shown one by one. URL addresses of the videos were obtained and then QR Codes were created. When the code is scanned with a smartphone, it automatically redirects the user to the specified URL. The difference between the groups was that videos on newborn care were shown and QR Code training guides with the same content as the SC group created by the researchers on newborn care were distributed.

Other: Group receiving QR code supported training

Recommendations to start care

NO INTERVENTION

In the training class, mothers who are preparing for discharge are currently given training on the appearance, feeding, care, vaccinations, sleep and health checks of the premature infant, and the care of the newborn is carried out practically.

Interventions

During the training process, QR codes were integrated into the sections related to the care of the newborn in the guide to provide mothers with the opportunity to watch the video simultaneously while reading the guide in practices requiring skills related to hygienic care of the newborn and nutrition / communication / sleep, and to allow them to watch it repeatedly as long as they feel the need. In these videos, the application steps were shown one by one. When the code is scanned with a smartphone, it automatically redirects the user to the specified URL. The QR codes in the Implementation Guide on the Care of the Newborn consist of eight videos) that allow mothers to watch the hygienic care of the newborn in practice. After the end of this phase of the training, the questionnaires were re-administered to the mothers in both groups one month after discharge.

Group receiving QR code supported training

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMust be biological mother
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Preterm infant who were born between 28-36+6 gestational weeks
  • Preterm infant with a low birth weight at hospitalization (between 1500-2500 g)
  • Preterm infant weight of 2500 g or more at discharge,
  • Preterm infant who had stable vital signs,
  • Preterm infant who do not use muscle relaxants, analgesics, sedatives or inotropic drugs,
  • Preterm infant who do not have a serious neurological disease
  • Mothers who stay with the baby for at least one month after discharge,
  • Mothers who voluntarily accepting the study,
  • Mothers who not being diagnosed with a psychiatric illness.

You may not qualify if:

  • Mothers who did not have the ability to read and understand Turkish,
  • Mothers who did not use/access the internet,
  • Mothers who had twin babies
  • Mothers whose babies with a disease that would prevent post-discharge care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, İzmit, 41380, Turkey (Türkiye)

Location

Related Publications (15)

  • Bellot J, Shaffer K, Wang M. Use of quick response coding to create interactive patient and provider resources. J Nurs Educ. 2015 Apr;54(4):224-7. doi: 10.3928/01484834-20150318-07.

    PMID: 25826764BACKGROUND
  • Barnes CR, Adamson-Macedo EN. Perceived Maternal Parenting Self-Efficacy (PMP S-E) tool: development and validation with mothers of hospitalized preterm neonates. J Adv Nurs. 2007 Dec;60(5):550-60. doi: 10.1111/j.1365-2648.2007.04445.x.

    PMID: 17973719BACKGROUND
  • Afand N, Keshavarz M, Fatemi NS, Montazeri A. Effects of infant massage on state anxiety in mothers of preterm infants prior to hospital discharge. J Clin Nurs. 2017 Jul;26(13-14):1887-1892. doi: 10.1111/jocn.13498. Epub 2017 Mar 24.

    PMID: 27486850BACKGROUND
  • Kadiroglu T, Guducu Tufekci F. Effect of Infant Care Training on Maternal Bonding, Motherhood Self-Efficacy, and Self-Confidence in Mothers of Preterm Newborns. Matern Child Health J. 2022 Jan;26(1):131-138. doi: 10.1007/s10995-021-03287-0. Epub 2021 Nov 27.

    PMID: 34837599BACKGROUND
  • Pazarcıkcı F, Efe E. (2017). Preterm Bebeklerin Taburculuk Sonrası Evde Bakımının Sağlanmasında Hemşirenin Rolü. MAKÜ Sag. Bil. Enst. Derg, 5 (1), 45-52.

    BACKGROUND
  • Pisoni C, Garofoli F, Baiardini I, Tzialla C, Stronati M. The development of parents-infant relationship in high-risk pregnancies and preterm birth. JPNIM, 2014, 3: e030233.

    BACKGROUND
  • Rawlins LN, Seaman KA. The Use of QR Codes to Engage Nursing Students With Next Generation NCLEX. J Nurs Educ. 2024 Mar;63(3):186-187. doi: 10.3928/01484834-20240108-02. Epub 2024 Mar 1.

    PMID: 38442404BACKGROUND
  • Ritchie SK. Primary care of the premature infant discharged from the neonatal intensive care unit. MCN Am J Matern Child Nurs. 2002 Mar-Apr;27(2):76-85. doi: 10.1097/00005721-200203000-00004.

    PMID: 11984275BACKGROUND
  • Shorey S, Chan SW, Chong YS, He HG. Maternal parental self-efficacy in newborn care and social support needs in Singapore: a correlational study. J Clin Nurs. 2014 Aug;23(15-16):2272-82. doi: 10.1111/jocn.12507. Epub 2013 Dec 26.

    PMID: 24372630BACKGROUND
  • Tognasso G, Gorla L, Ambrosini C, Figurella F, De Carli P, Parolin L, Sarracino D, Santona A. Parenting Stress, Maternal Self-Efficacy and Confidence in Caretaking in a Sample of Mothers with Newborns (0-1 Month). Int J Environ Res Public Health. 2022 Aug 5;19(15):9651. doi: 10.3390/ijerph19159651.

    PMID: 35955005BACKGROUND
  • Wolke D, Eryigit-Madzwamuse S, Gutbrod T. Very preterm/very low birthweight infants' attachment: infant and maternal characteristics. Arch Dis Child Fetal Neonatal Ed. 2014 Jan;99(1):F70-5. doi: 10.1136/archdischild-2013-303788. Epub 2013 Jun 21.

    PMID: 23792355BACKGROUND
  • Yayan, E. H., Özdemir, M., Düken, M. E., Suna Dağ, Y. (2019). Yenidoğan Yoğun Bakım Ünitesinde Bebeği Yatan Ebeveynlerin Stres Düzeylerinin Belirlenmesi, Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi (GÜSBD), 8(1), 82-89.

    BACKGROUND
  • Shrestha S, Adachi K, Petrini MA, Shrestha S, Rana Khagi B. Development and evaluation of a newborn care education programme in primiparous mothers in Nepal. Midwifery. 2016 Nov;42:21-28. doi: 10.1016/j.midw.2016.09.006. Epub 2016 Sep 15.

    PMID: 27710817BACKGROUND
  • Silva, I. O. A. M. D., Aredes, N. D. A., Bicalho, M. B., Delácio, N. C. B., Mazzo, L. D. L., & Fonseca, L. M. M. (2018). Booklet on premature infants as educational technology for the family: quasi-experimental study. Acta Paulista de Enfermagem, 31, 334-341. https://doi.org/10.1590/1982-0194201800048

    BACKGROUND
  • Caka SY, Topal S, Ozturkler S, Celenkoglu FT, Gunlemez A. The Effect of QR Code Supported Newborn Care Training Given to Mothers With Premature Infant on Self-Efficacy and Anxiety: A Randomised Controlled Study. Scand J Caring Sci. 2025 Sep;39(3):e70051. doi: 10.1111/scs.70051.

MeSH Terms

Conditions

Anxiety DisordersPremature Birth

Condition Hierarchy (Ancestors)

Mental DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blinding was used in the study. For this purpose, the participants were not specified in which group they belonged to the research. Therefore, a separate informed consent form was prepared for each group. In order to avoid bias in the analysis of the research data, statistician blinding was also applied. While coding the research data, the research groups were coded as A and B, and the statistician was prevented from knowing which letter represented which group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was conducted experimentally with a pre-test and post-test control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 11, 2024

Study Start

January 1, 2023

Primary Completion

December 1, 2023

Study Completion

March 23, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations