The Smell of Breast Milk and Therapeutic Positions in Comfort

NCT06826053 | Completed DMC

• 1 other identifier: smell of breast milk
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Before starting the data collection process, a pilot study was conducted with 10 preterm newborns, five in the safe swaddling group and five in the control group, to evaluate the comprehensibility of the questionnaire form and the feasibility of the application. The newborns included in the pilot study were not included in the study. At the beginning of the study, parents of newborns who met the sample selection criteria were informed about the purpose and content of the study and informed consent was obtained from those who agreed to participate in the study. Data were obtained from parents of infants 38 weeks and older who were hospitalized in the Tertiary NICU and who met the sample selection criteria by using data collection tools. Firstly, parents were informed about the study through the "Information and Informed Consent Form" (Appendix-E). They were included in the study if they volunteered. Written informed consent was obtained from the parents who volunteered to participate in the study. Data were collected using "Data Collection Tools" prepared by the researcher. Newborns will be randomly divided into two groups;

• Group 1: Therapeutic position
• Group 2: Therapeutic position + the smell of breast milk Number, percentage, mean and standard deviation will be used in the descriptive statistics of the study. The normality of the data will be evaluated with the Kolmogrow Smirnow test. Kappa analysis will be used in the evaluation of inter-observer agreement. Chi-square test will be used for the comparison of categorical data, t test and Anova in independent groups will be used for the comparison of normally distributed data, Friedman, Wilcoxon, Mann Whitney U and Kruskal Wallis tests will be used for the comparison of non-normally distributed data. Within-group evaluation will be evaluated by repeated measures analysis of variance. Significance level p\<0.05 will be accepted. Continuous data will be shown as mean ± standard deviation for normally distributed data, median and 25-75th quartile for non-normally distributed data, and frequency and percentage for categorical data. For comparisons of differences between categorical variables by groups, Pearson chi-square test will be used for RxC tables with expected observations of 5 and above and Fisher Freeman Halton test will be used for RxC tables with expected observations below 5.

Conditions

Respiratory Distress

Keywords

respiratory distress; therapeutic position; the smell of breast milk; term neonatal

Outcome Measures

Primary Outcomes (3)

• heart rate

  heart rate

  every 30 minutes for two hours

• oxygen saturation values

  oxygen saturation values

  every 30 minutes for two hour

• respiratory rate

  respiratory rate

  every 30 minutes for two hours

Secondary Outcomes (1)

• Neonatal Comfort Behavior Scale Score

  every 30 minutes for two hours

Study Arms (2)

Therapeutic position group

EXPERIMENTAL

Therapeutic group

Other: Therapeutic position

Therapeutic position + smell of breast milk

EXPERIMENTAL

Therapeutic position + smell of breast milk

Other: Therapeutic position + smell breast milk

Interventions

Therapeutic position OTHER

each newborn was given four different therapeutic positions in sequence.

Therapeutic position group

Therapeutic position + smell breast milk OTHER

each newborn will be given four different therapeutic positions in sequence and will be made to smell the scent of breast milk.

Therapeutic position + smell of breast milk

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• NICU admission immediately after birth.
• The babies were term births (births at 38 weeks and above).
• The baby was not given analgesics and/or sedatives.
• The baby had spontaneous breathing.
• Families\' acceptance to participate in the study.

You may not qualify if:

• With a thoracic tube, umbilical vein catheter or dialysis catheter.
• With active infection.
• Tachypnea and unstable oxygen saturation ≤ 90%.
• Receiving sedation therapy.

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Karamanoglu Mehmetbey University

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: February 13, 2025
• Study Start: March 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: July 30, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)