NICUNICUNCT07074197
The Effect of Smelling the Scent of Infants Hospitalized in the Neonatal Intensive Care Unit
A study testing OOKIE doll in people with NICU, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- NICU
- What is being tested?
- OOKIE doll
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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
- NICU
- Being tested
- OOKIE doll
- Keywords
- NICU, infant, mother, stress, scent, attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OOKIE dollOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: OOKIE doll |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-4.day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start15 Jun 2022
- Primary completion30 May 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was a randomized controlled experimental, prospective study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Kucuk Alemdar, Ordu University
- Investigators
- Dilek Küçük Alemdar, professor, Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074197
- Sponsor's protocol ID
- KAEK86
- Acronym
- NICU
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07074197
- Acronym / sponsor ID
- NICU / KAEK86
- Conditions
- NICU
- Keywords
- NICU, infant, mother, stress, scent, attachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was a randomized controlled experimental, prospective study.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: OOKIE dollThe 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OOKIE dollThe 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. | Other | OOKİE group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Küçük Alemdar, professor study director
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OOKIE doll in people with NICU, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Intensive Care Parent Stress Scale (time frame: 1-4. day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.