CompletedNot Applicable

Baby Smell Visual Stimulus Program Cortical and Breast Oxygenation Milk Amount Mother-Infant Attachment

Turkey (Türkiye)54 participantsStarted 2022-08-19

Plain-language summary

In this study, the effect of infant odor and visual stimulus program applied to mothers who had delivered by cesarean section and whose babies were taken to the NICU on cortical and breast oxygenation (rSO2), amount of breast milk and mother-infant bonding was investigated.

Who can participate

Age range

28 Weeks – 37 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Infant * Born at 28-37 (36+6) weeks of gestation * Admission to the NICU in the same hospital as the mother immediately after birth Mother * To agree to participate in the study, * To give birth by cesarean section, * To be able to use the Turkish language, * To pass the smell test (to correctly identify the 3 different types of smell presented), * Not to have been diagnosed with depression etc. Psychiatry at the time of the study Exclusion Criteria: Infant * The presence of conditions that affect the baby's original smell (baby born with Meconium, Hepatitis C and HIV infected baby) * Infant who underwent interventional intervention in the head area * The baby whose suction function is sufficient and who can suck breast milk Mother * Admission to Intensive Care, * Being covid positive (as the sense of smell will be affected), * Having a mental, neurological, nasal related disease, * Having a communication problem

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cortical and Breast Oxygenation Follow-up Parameter

Timeframe: First measurement- At 12th hour of the postpartum period.

Cortical and Breast Oxygenation Follow-up Parameter

Timeframe: Second measurement- At 24th hour of the postpartum period.

Milk Amount Follow-up Form

Timeframe: First measurement- At 12th hour of the postpartum period.

Milk Amount Follow-up Form

Timeframe: Second measurement- At 24th hour of the postpartum period.

Mother to Infant Bonding Scale

Timeframe: First measurement- Within 1 hour of the postpartum period.

Mother to Infant Bonding Scale

Timeframe: Second measurement- At 24th hour of the postpartum period.

Mother and Infant Information Tool

Timeframe: First measurement- Within 1 hour of the postpartum period.

Trial details

NCT IDNCT06058208

SponsorSelcuk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-13

View on ClinicalTrials.gov More Cesarean Delivery Affecting Fetus trials

Who can participate

Age range

28 Weeks – 37 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cortical and Breast Oxygenation Follow-up Parameter

Timeframe: First measurement- At 12th hour of the postpartum period.

Cortical and Breast Oxygenation Follow-up Parameter

Timeframe: Second measurement- At 24th hour of the postpartum period.

Milk Amount Follow-up Form

Timeframe: First measurement- At 12th hour of the postpartum period.

Milk Amount Follow-up Form

Timeframe: Second measurement- At 24th hour of the postpartum period.

Mother to Infant Bonding Scale

Timeframe: First measurement- Within 1 hour of the postpartum period.

Mother to Infant Bonding Scale

Timeframe: Second measurement- At 24th hour of the postpartum period.

Mother and Infant Information Tool

Timeframe: First measurement- Within 1 hour of the postpartum period.