The Effect of Smelling the Scent of Infants Hospitalized in the Neonatal Intensive Care Unit

NCT07074197 | Completed

• 1 other identifier: KAEK86
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NICU

Keywords

NICU; infant; mother; stress; scent; attachment

Outcome Measures

Primary Outcomes (4)

• Neonatal Intensive Care Parent Stress Scale

  Parents were asked to rate the level of stress caused by each of the factors in the scale from one (no stressor) to five (extreme stressor). Factors with a mean score between 3.0 and 3.40 are considered moderately stressful, and factors with a mean score \>3.40 are considered very stressful. Stress factors are analyzed in 3 subgroups. The first is the "Sights and Sounds" subgroup, which includes factors such as the presence of equipment on the baby or in the intensive care unit, sounds arising from them and the environment. The second is the "Appearance and Behavior of the Baby" subgroup, and the third is the factors related to the "Role of the Parents". While filling in the statements such as the presence of tubes and other equipment on or near the baby, sudden change in the baby's color or the baby's breathing stopping, mothers whose babies did not have these symptoms did not mark these items.

  1-4. day

• Inadequate Milk Perception Scale

  The inadequate milk perception scale is a form consisting of 6 questions. In the first question, the mother is asked whether she believes that she is feeding her baby enough. The mother answers this question as "yes" or "no". The other questions of the scale aim to measure the perception of milk insufficiency. The mother is asked to score these questions between 0-10. "0" indicates that milk is perceived as completely inadequate and "10" indicates that milk is perceived as completely adequate. A minimum score of 0 and a maximum score of 50 can be obtained from the scale. A higher total score indicates a higher perception of milk adequacy. In the original scale, Cronbach α value was determined as 0.81.

  1-4. day

• Mother-Infant Attachment Scale

  The scale is designed to be applied from the first day after birth and allows the mother to express her feelings towards her baby with a single word. The Mother-Infant Attachment Scale (MICS) is a 4-point Likert scale consisting of 8 items. The responses consisting of four options are scored between 0-3, with the lowest score being 0 and the highest score being 24. In the evaluation, items 1, 4, and 6 are positive emotion expressions and are scored as 0,1,2,3, while items 2, 3, 5, 7, and 8 are negative emotion expressions and are scored as 3,2,1,0.

  1-4.day

• NICU Parental Beliefs Scale

  The scale is a 5-point Likert-type scale consisting of a total of 18 items. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). The highest score that can be obtained from the scale is 90 and the lowest score is 18. The scale has three sub-dimensions: Parental Role Confidence, Parent-Baby Interaction and Knowledge of the NICU. Higher scores indicate higher parental beliefs and lower scores indicate lower parental beliefs.

  1-4.day

Study Arms (2)

Control

NO INTERVENTION

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.

OOKİE group

EXPERIMENTAL

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

Other: OOKIE doll

Interventions

OOKIE doll 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.

OOKİE group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University

Altinordu, Ordu, 52200, Turkey (Türkiye)

Location

Study Officials

• Dilek Küçük Alemdar, professor

  Ordu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study was a randomized controlled experimental, prospective study.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: June 15, 2022
• Primary Completion: May 30, 2023
• Study Completion: July 15, 2023
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)