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

NCT ID: NCT05557435

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-09-30

Brief 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.

Detailed Description

Preterm infants need to undergo more invasive medical interventions than full-term healthy newborns to maintain their lives. Physiological functions changes brought about by pain and stress stimulations may complicate nerve development in preterm infants. Therefore, providing positive sensory supportive interventions to reduce pain and stress is imperative for preterm infants. Studies have confirmed that the use of painkillers, breastfeeding, swaddling, kangaroo care, giving glucose or sucrose can help reduce pain. The sense of smell matures at 28 weeks of gestation age, and newborns can recognize the mother's smell after birth (Nishitani et al., 2009).

In recent years, several randomized studies have explored the effects of smell on reducing pain and stress in preterm infants, but the results are still inconclusive due to the lack of randomization blinding and a variety of smell interventions. It is desirable to plan a high-quality study. Although premature infants need to be separated from their mothers in nurseries due to medical needs, breast milk is still the best source of nutrition. The aims of this study are to investigate the effect of breast milk odor on pain response and saliva cortisol level duration heel stick blood sampling in preterm infants with gestation age at 30 to 37 weeks. A Randomized Controlled Trial will be designed. Preterm infants, who will receive heel sticks, are 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. Data will be analyzed by SPSS 22.0 (SPSS Inc., Chicago, IL, USA) using descriptive statistics, independent t-test, ANOVA, Generalized Estimating Equation linear multiple regression analysis… etc.

Conditions

Premature Infant; Pain; Breast Milk Odor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Breast milk odor

Participants received breast milk odor before and during heel stick.

Group Type: EXPERIMENTAL

breast milk odor

Intervention Type: OTHER

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.

Placebo

Participants received placebo before and during heel stick.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

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.

Intervention Type: OTHER

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Premature babies whose gestational age is between 30 weeks to 36 weeks and six days, with a birth weight > 1000 grams.

2. Apgar Score > 6 at 5 minutes of birth.

3. Within 10 days of birth, the vital signs are stable.

4. Those who have medical needs, such as blood monitoring of neonatal serum bilirubin, blood sugar, electrolyte, or neonatal screening, etc., need heel puncture blood sampling.

Exclusion Criteria

1. Those who have been diagnosed by a physician with severe congenital malformations, chromosomal abnormalities, respiratory distress, epilepsy, necrotizing enterocolitis, intracranial hemorrhage, periventricular leukomalacia, sepsis, meningitis, or hyperbilirubinemia.

2. Those who have bronchopulmonary dysplasia or other chronic lung diseases that require the use of ventilator or non-invasive positive pressure respiratory support.

3. Have used analgesics or anesthetics within 48 hours before giving the intervention of the study, or are participating in other studies that provide intervention for pain reduction.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Kee Hsin Chen, Ph.D

Role: CONTACT

keehsin@tmu.edu.tw

+886-2-2736-1661 ext. 3613

Meng Ting Tsai, RN

Role: CONTACT

m432109011@tmu.edu.tw

+886-981354095

Other Identifiers

N202204023

Identifier Type: -

Identifier Source: org_study_id