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The Effect of Breast Milk Odor on Pain Response and Salivary Cortisol Level in Preterm Infants

NCT05557435 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-12-01

No results posted yet for this study

Summary

The aims of this randomized controlled trial are investigate the effects of breast milk odor on pain response and saliva cortisol level duration heel stick blood sampling in preterm infants. Partipants will randomly assigned into the experimental group (breast milk odor) or control group (distilled water odor). The Premature Infant Pain Profile-Revised (PIPP-R) and Salimetrics® Cortisol Enzyme Immunoassay Kit are used to measuring the pain response and saliva cortisol level.

Conditions

  • Premature Infant
  • Pain
  • Breast Milk Odor

Interventions

OTHER

breast milk odor

The intervention of the experimental group was to stimulate the odor of breast milk. The researchers informed the mothers of premature infants in advance on the day before the experiment, and collected the breast milk samples in the morning before eating on the day of the experiment (excluding the influence of the odor of breast milk by diet). The researchers took a clean cotton ball so that the breast milk was completely absorbed by the cotton ball, and placed the cotton ball that absorbed breast milk at a distance of 5cm next to the mouth and nose of the premature infant, so that the premature infant could receive the smell of breast milk. The intervention of the control group was to stimulate the smell of distilled water.

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Taipei Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-09-01
Completion
2023-09-30

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Diseases

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 NCT05557435 on ClinicalTrials.gov