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The Smell of Breast Milk and Therapeutic Positions in Comfort

NCT06826053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-02-18

No results posted yet for this study

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

Interventions

OTHER

Therapeutic position

each newborn was given four different therapeutic positions in sequence.

OTHER

Therapeutic position + smell breast milk

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

Sponsors & Collaborators

  • Karamanoğlu Mehmetbey University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-04-01
Completion
2024-07-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06826053 on ClinicalTrials.gov