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Completed

NCT Number: NCT07074197

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

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.

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Key information

Conditions

NICU

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Altinordu, Ordu, 52200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Neonatal Intensive Care Parent Stress Scale

    Time frame: 1-4. day

    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.

  2. Inadequate Milk Perception Scale

    Time frame: 1-4. day

    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.

  3. Mother-Infant Attachment Scale

    Time frame: 1-4.day

    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.

  4. NICU Parental Beliefs Scale

    Time frame: 1-4.day

    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.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

The Effect of Smelling the Scent of Infants Hospitalized in the Neonatal Intensive Care Unit on Mothers' Stress, Attachment and Perception of Insufficient Milk

Acronym: NICU

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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