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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2023-07-15

Brief Summary

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The study was conducted to determine the effect of having mothers with infants in the neonatal intensive care unit smell their baby's odor with OOKIE dolls on stress, attachment and perception of insufficient milk.

Detailed Description

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The infant who met the study selection criteria was wrapped with OOCIE upon admission and remained in contact with OOCIE for approximately 24 hours without affecting routine care and positioning. 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 took 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.

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

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NICU

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was a randomized controlled experimental, prospective study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
After the mothers of newborns who met the inclusion criteria were randomly assigned to the study groups, written informed consent was obtained without informing the parents about which group their infants would be included in. The researcher placed the OOKIE baby next to the infant herself and then gave it to the mother, so the researcher was not blinded. However, to avoid bias, the outcome measures were recorded by two nurses working in the NICU, who were university graduates and did not know which mother was in the experimental or control group. To avoid bias during data analysis, the database of the study groups was coded as A and B by someone other than the researcher, and the data were analyzed by an independent statistician. Blinding of outcome measurements, statistical analysis and reporting was performed to prevent statistical and reporting bias.

Study Groups

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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.

Group Type NO_INTERVENTION

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

Group Type EXPERIMENTAL

OOKIE doll

Intervention Type OTHER

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

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The mother's voluntary acceptance to participate in the study.
* 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 illiteracy,
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ordu University

OTHER

Sponsor Role lead

Responsible Party

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Dilek Kucuk Alemdar

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Küçük Alemdar, professor

Role: STUDY_DIRECTOR

Ordu University

Locations

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Ordu University

Altinordu, Ordu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KAEK86

Identifier Type: -

Identifier Source: org_study_id

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