NCT05402787

Brief Summary

Virtual visit, which is frequently used in the field of health in line with the latest technological developments, is accepted as a unique opportunity that allows babies and their families to connect in real time. Studies have reported that virtual visits increase mothers' sense of closeness to their babies and have positive effects on the attachment process (Dunham and Marin 2020; Flacking et al. 2014; Joshi et al. 2016). It is clearly emphasized that healthy and securely attached babies have positive effects on health. This study was designed as a randomized controlled experimental study in order to determine the effect of virtual visit applied to mothers whose babies are in the neonatal intensive care unit on their attachment and satisfaction. Research Hypotheses: H0: There is no difference between the attachment and satisfaction of mothers whose babies were hospitalized in the neonatal intensive care unit, and those who did not receive virtual visits. H1: Attachment and satisfaction of mothers whose babies are hospitalized in the neonatal intensive care unit with virtual visits are higher than mothers who do not receive virtual visits.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Status
unknown

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

First Submitted

Initial submission to the registry

April 8, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

Same day

First QC Date

April 8, 2022

Last Update Submit

May 30, 2022

Conditions

Keywords

Virtual visitAttachmentSatisfactionNewborn

Outcome Measures

Primary Outcomes (2)

  • Evaluation of attachment in study and control groups

    The Maternal Attachment Scale is a four-dimensional, one-dimensional, 26-item scale with each item ranging from 'always' to 'never'. Each item includes direct statements and always=4 points, often=3 points, sometimes=2 points. , is calculated as never = 1 point. The lowest score to be obtained from the scale is 26, and the highest score is 104. A high score indicates high maternal attachment.

    Change between attachment status before the first virtual visit (24 hours after birth), at least one week after admission to one month)., and one month after discharge.

  • Evaluation of family satisfaction in neonatal intensive care in study and control groups

    The EMPATHIC-30 ((EMpowerment of Parents in THe Intensive Care ) scale is 6-point Likert-type (1= strongly disagree; 6 = strongly agree) and consists of five domains: knowledge (5 items), care and treatment (8 items) , organization (5 items), parent involvement (6 items) and professional attitude of staff (6 items) Scores ≤3 in each item are considered "Negative" while ≥4 points are considered "Positive" Average scores for each area ; (total score / total number of items in each field) formula

    Change between satisfaction before the first virtual visit (24 hours after birth) and at least one week after admission to one month

Study Arms (2)

Experimental

EXPERIMENTAL

The virtual visit will be started within the first 24 hours after birth. Mothers in this group will be informed about how the virtual visit will be. The virtual visit will be made online through the Whatshup video call program. The virtual visit will be twice a day, starting 24 hours after birth until the baby's first meeting with the mother. The first virtual visit to be made during the day will be aimed at understanding the mother's feelings, increasing her motivation and informing about the clinical condition of the baby. In the second interview, it will be supported to provide approximately 10 minutes of visual and audio communication that will help the mother to establish a connection with her baby. During the virtual visiting hour, the videos of the baby will be sent to the mother so that the mother can watch it. In each visit, it will be ensured that the mother sees her baby in every situation by paying attention to the fact that the baby is in a different situation.

Other: Virtual visit

Control Groups

NO INTERVENTION

The mothers in the control group will be followed in line with the hospital's routine health monitoring and information.

Interventions

A virtual visit will be made to mothers whose babies are hospitalized in the neonatal intensive care unit

Experimental

Eligibility Criteria

Age19 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMothers of infants hospitalized in the neonatal intensive care unit
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Premature (\>32 and and \<35 GW) of the newborn
  • To be admitted to the neonatal intensive care unit within the first 24 hours after birth
  • Absence of visible congenital anomaly (Cleft palate, cleft lip, craniofacial anomaly such as facial muscle paralysis etc.)
  • Hospitalization of the newborn in the neonatal intensive care unit for at least 1 week and the continuation of the virtual visit
  • Absence of a diagnosed psychiatric history of the mother
  • Mother's willingness to participate in the study
  • The mother has a primiparous and singleton baby
  • Mother is over 18 years old
  • The mother can speak and understand Turkish well and be literate
  • Pregnancy not realized by assisted reproductive technique
  • The mother who has a smart phone, computer, tablet and wireless internet will be included in the study.

You may not qualify if:

  • Premature (\<32 and \>35 GW) of the newborn
  • Not being admitted to the neonatal intensive care unit within the first 24 hours after birth
  • Congenital anomaly in the newborn (Craniofacial anomaly such as cleft palate, cleft lip, paralysis of facial muscles)
  • Discharge of the newborn before 1 week
  • Mother's unwillingness to participate in the study
  • Mother's illiteracy
  • The mother has a multiparous or multiple baby
  • The mother has a diagnosed psychiatric history
  • Mother is 18 years or younger
  • The mother did not have a smart phone, computer, tablet or wireless internet at the time of the study
  • Pregnancy with assisted reproductive technique
  • The mother's incomplete filling of the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Çınar N, Köse D. Aile -Bebek Bağlanma Süreci, Aile Temelli Sağlık Yaklaşımı, Ed: S.Kuğuoğlu, B.C. Demirbağ, 2015.

    BACKGROUND
  • Cinar N, Kose D, Altinkaynak S. The relationship between maternal attachment, perceived social support and breast-feeding sufficiency. J Coll Physicians Surg Pak. 2015 Apr;25(4):271-5.

    PMID: 25899193BACKGROUND
  • Dunham MM, Marin T. NICU Maternal-Infant Bonding: Virtual Visitation as a Bonding Enhancement Tool. J Perinat Neonatal Nurs. 2020 Apr/Jun;34(2):171-177. doi: 10.1097/JPN.0000000000000484.

    PMID: 32332447BACKGROUND
  • Flacking R, Lehtonen L, Thomson G, Axelin A, Ahlqvist S, Moran VH, Ewald U, Dykes F; Separation and Closeness Experiences in the Neonatal Environment (SCENE) group. Closeness and separation in neonatal intensive care. Acta Paediatr. 2012 Oct;101(10):1032-7. doi: 10.1111/j.1651-2227.2012.02787.x. Epub 2012 Aug 2.

    PMID: 22812674BACKGROUND
  • Forcada-Guex M, Borghini A, Pierrehumbert B, Ansermet F, Muller-Nix C. Prematurity, maternal posttraumatic stress and consequences on the mother-infant relationship. Early Hum Dev. 2011 Jan;87(1):21-6. doi: 10.1016/j.earlhumdev.2010.09.006. Epub 2010 Oct 15.

    PMID: 20951514BACKGROUND
  • İşler A. Prematüre bebeklerde anne-bebek ilişkisinin başlatılmasında yenidoğan hemşirelerinin rolü. Perinatoloji Dergisi 2007;15 (1): 1-6.

    BACKGROUND
  • Joshi A, Chyou PH, Tirmizi Z, Gross J. Web Camera Use in the Neonatal Intensive Care Unit: Impact on Nursing Workflow. Clin Med Res. 2016 Mar;14(1):1-6. doi: 10.3121/cmr.2015.1286. Epub 2016 Feb 10.

    PMID: 26864509BACKGROUND
  • Köse D, Çınar N, Altınkaynak S. Yenidoğanın anne ve baba bağlanma süreci. STED Dergisi 2013; 226: 239-245.

    BACKGROUND
  • Menekşe ve Çınar N, Anne Bebek Bağlanması, İçinde Anne v eÇocuk Sağlığı İlk 1000 gün (Eds. Nursan Çınar, Sevil Şahin), Akademisyen Kitabevi,2020, 425-451.

    BACKGROUND
  • Mercer RT. Becoming a mother versus maternal role attainment. J Nurs Scholarsh. 2004;36(3):226-32. doi: 10.1111/j.1547-5069.2004.04042.x.

    PMID: 15495491BACKGROUND
  • Nacar EH, Gökkaya F. Bağlanma ve maternal bağlanma konusunda bir derleme. Cyprus Turkish Journal of Psychiatry & Psychology 2019; 1 (1): 50-56.

    BACKGROUND
  • Pisoni C, Garofoli F, Baiardini I, Tzialla C, Stronati M. The development of parents-infant relationship in high-risk pregnancies and preterm birth. Journal of Pediatric and Neonatal Individualized Medicine 2014b;3 (2): 1-7.

    BACKGROUND
  • Scatliffe N, Casavant S, Vittner D, Cong X. Oxytocin and early parent-infant interactions: A systematic review. Int J Nurs Sci. 2019 Sep 12;6(4):445-453. doi: 10.1016/j.ijnss.2019.09.009. eCollection 2019 Oct 10.

    PMID: 31728399BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dilek Menekşe, Asist. prof.

    Sakarya University

    STUDY DIRECTOR
  • Öznur Tiryaki, Asist. prof.

    Sakarya University

    PRINCIPAL INVESTIGATOR
  • Nursan Çınar, Prof.Dr.

    Sakarya University

    PRINCIPAL INVESTIGATOR
  • Seda Tecik, Res.Asist.

    Sakarya University

    PRINCIPAL INVESTIGATOR
  • Hatice Solak, Nurse

    Sakarya Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Meltem Karabay, Asist.Prof

    Sakarya University

    PRINCIPAL INVESTIGATOR
  • İbrahim Caner, Prof.Dr.

    Sakarya University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Menekşe, Asist.prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single-blind (researchers are not blinded) randomization will be provided as the virtual visitation to mothers will be implemented by researchers. The statistician was also blinded for the data analysis purpose
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 8, 2022

First Posted

June 2, 2022

Study Start

June 20, 2022

Primary Completion

June 20, 2022

Study Completion

May 1, 2023

Last Updated

June 2, 2022

Record last verified: 2022-05