The Effect of Smelling the Scent of Infants Hospitalized in the Neonatal Intensive Care Unit
NCT ID: NCT07074197
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2022-06-15
2023-07-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Maternally Scent-digested Blanket on Stress, Crying and Physiological Parameters of Premature Newborns
NCT06437106
Baby Smell Visual Stimulus Program Cortical and Breast Oxygenation Milk Amount Mother-Infant Attachment
NCT06058208
Breast Milk Odor on the Pain and Stress Level of the Newborn Endotracheal Aspiration Procedure
NCT05331846
The Effect of Lullaby and Breastmilk Smell on Preterm Newborns
NCT05830955
Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort
NCT06120062
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
OOKIE, which will be used in the study, is a doll made of 100% cotton flannel fabric, with satin edges, 35cmx 40cm in size and produced in various colors. Due to its structure, it can be easily washed, dried and sterilized. The fabric feature is capable of trapping and transferring odor. It is a suitable tool for mothers who are separated from their babies in the intensive care environment, which can mediate the smell of their babies.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Control group: No intervention was made except for the routine care provided at the clinic where the study was conducted. Routine practices included allowing the mother to visit and see her baby at the clinic whenever she wanted. When the mother came for the first visit, the mother and baby introductory information form, Neonatal Intensive Care Unit Parent Stress Scale, Inadequate Milk Perception Scale, Mother-Infant Attachment Scale and NICU Parental Beliefs Scale pretest were administered. On the third day, when the mothers came to visit their babies, the same scales were administered as posttest.
No interventions assigned to this group
OOKİE group
The infants who met the selection criteria were wrapped with OOKIE upon admission and remained in contact with OOKIE for approximately 24 hours without affecting their routine care and position. After 24 hours, when the mother came for the first visit, the mother and baby introductory information form, Neonatal Intensive Care Unit Parent Stress Scale, Inadequate Milk Perception Scale, Mother-Infant Attachment Scale and NICU Parental Beliefs Scale pretest were administered. During the visit, the mother received the OOKIE wrapped around her baby in the incubator and stayed with the mother for 3 days and the mother could smell her baby's odor whenever she wanted.
The OOKIE used in the study is a doll made of 100% cotton flannel fabric, with satin edges, 35cmx 40cm in size and produced in various colors. Due to its structure, it can be easily washed, dried and sterilized. The fabric feature is capable of trapping and transferring odor. It is a suitable tool for mothers who are separated
OOKIE doll
The infants who met the selection criteria were wrapped with OOCIE upon admission and remained in contact with OOCIE for approximately 24 hours without affecting their routine care and position. After 24 hours, when the mother came for the first visit, the mother and baby introductory information form, Neonatal Intensive Care Unit Parent Stress Scale, Inadequate Milk Perception Scale, Mother-Infant Attachment Scale and NICU Parental Beliefs Scale pretest were administered. During the visit, the mother received the OOKIE wrapped around her baby in the incubator and stayed with the mother for 3 days and the mother could smell her baby's odor whenever she wanted.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OOKIE doll
The infants who met the selection criteria were wrapped with OOCIE upon admission and remained in contact with OOCIE for approximately 24 hours without affecting their routine care and position. After 24 hours, when the mother came for the first visit, the mother and baby introductory information form, Neonatal Intensive Care Unit Parent Stress Scale, Inadequate Milk Perception Scale, Mother-Infant Attachment Scale and NICU Parental Beliefs Scale pretest were administered. During the visit, the mother received the OOKIE wrapped around her baby in the incubator and stayed with the mother for 3 days and the mother could smell her baby's odor whenever she wanted.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The baby received treatment for at least 3 days in the NICU,
* The baby did not have any congenital anomaly, and the baby did not undergo any surgical procedure.
Exclusion Criteria
* Mother's having an obstacle to communication,
* Referral of the baby to another center,
* Mother's having an obstacle to breastfeeding or mothers who do not want to breastfeed,
* Mother's having an olfactory problem.
18 Years
55 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ordu University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dilek Kucuk Alemdar
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dilek Küçük Alemdar, professor
Role: STUDY_DIRECTOR
Ordu University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ordu University
Altinordu, Ordu, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KAEK86
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.