Pacifier Use During Phototherapy in Newborns With Hyperbilirubinemia

August 28, 2024 updated by: Ahu Pınar TURAN, Hitit University

Effect of Pacifier Use During Phototherapy on Stress and Bilirubin Level in Newborns With Hyperbilirubinemia

Hyperbilirubinemia; It is a common condition that usually occurs physiologically in newborns. Phototherapy is used in the treatment of hyperbilirubinemia. Babies cry while receiving phototherapy, the mother's inability to hold her baby in her arms, her inability to breastfeed, and the invasive procedures (bloodletting) stress the baby. Pacifiers are used among individualized developmental care practices to calm the baby and reduce stress. Another benefit of pacifiers for the baby is on the gastrointestinal system. Non-nutritive sucking stimulates oro-motor development, facilitates the development of sucking behavior and facilitates digestion in enteral feeding. Considering all these benefits, this study aimed to determine the effect of pacifier use during phototherapy on stress and bilirubin levels in newborns with hyperbilirubinemia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

After birth, fetal erythrocytes in the newborn are rapidly destroyed and the total bilirubin level increases, resulting in hyperbilirubinemia. Hyperbilirubinemia; although it is a common condition that usually occurs physiologically in newborns, it causes neurological dysfunction in the newborn when it reaches high bilirubin levels. Therefore, follow-up and treatment are important. One of the treatment approaches for hyperbilirubinemia is phototherapy.

Phototherapy treatment is applied to babies diagnosed with hyperbilirubinemia by directly giving light energy to the babies. While receiving phototherapy, the baby becomes stressed due to reasons such as the mother not being able to hold her baby in her arms, not being able to breastfeed, the baby being in a different environment such as the neonatal intensive care unit, and being exposed to invasive procedures. Individualized developmental care practices accordingly, many practices are recommended in neonatal intensive care units to reduce the stress of babies. One of these practices is non-nutritive sucking. The most commonly used method for non-nutritive sucking is the use of a pacifier. It is stated that the use of pacifiers helps the baby calm down and reduces stress in neonatal intensive care units. In 1990, the World Health Organization and the United Nations International Children's Emergency Fund determined the "Ten Steps to Successful Breastfeeding" principles for the Baby-Friendly Hospital Initiative to promote and support breastfeeding. It has been noticed that in these principles rejecting the use of pacifiers, intensive care environments where the baby is stressed and situations where the mother and the baby are separated are ignored, so it has been suggested that this situation should be brought back to the agenda. In 2013, the "Ten Steps to Successful Breastfeeding" application was revised; Considering the justified reasons for the special situations in which the newborn and the mother and the baby are separated and the situations in which the baby is stressed, the newborn The use of pacifiers has been recommended in intensive care units. Considering the 24-hour treatment period during phototherapy, the baby is separated from the mother, albeit intermittently, while receiving phototherapy. In addition, the baby is in a different environment such as the neonatal intensive care unit and is exposed to invasive procedures. All of these create stress in the baby, and pacifiers are recommended for such justified reasons. The benefits of pacifier use have been proven in neonatal intensive care units, such as calming the baby, making it easier to fall asleep, and reducing pain and stress. Another benefit of non-nutritive sucking is on the gastrointestinal system. Non-nutritive sucking stimulates oro-motor development, facilitates the development of sucking behavior and facilitates digestion in enteral feeding.

A number of enzymes and hormones are involved in facilitating digestion through non-nutritive absorption. These enzymes and hormones; lingual lipase, gastrin, insulin and motilin. Experts believe that non-nutritive sucking causes this effect through vagal stimulation of the oral mucosa. It is thought that it causes the secretion of enzymes and hormones. Non-nutritive sucking in a study reported that the use of pacifiers, one of the methods, stimulates the stomach motor functions and this facilitates the digestive process through the activation of vagal mechanisms.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Istanbul University Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Term newborns
  • Newborns diagnosed with hyperbilirubinemia
  • Babies who do not use pacifiers
  • Newborns scheduled to receive phototherapy for 24 hours
  • Babies of parents who agreed to participate in the study

Exclusion Criteria:

  • Newborns receiving other treatments along with phototherapy
  • Newborns with a diagnosis other than hyperbilirubinemia
  • Newborns using antibiotics
  • Babies fed with formula milk or bottle
  • Babies diagnosed with pathological Hyperbilirubinemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The newborns in the experimental group were given a pacifier.
Other: Pacifier Use
The newborns in the experimental group were given a pacifier, unlike the control group. The newborns were placed in a phototherapy incubator and each time they were placed in a phototherapy incubator, the newborns were given a pacifier for an average of 5 minutes. The researcher encouraged the babies to take the pacifier.
No Intervention: Control group
The newborns in the control group were not given a pacifier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood bilirubin level
Time Frame: 18th and 24th hours
The blood bilirubin level of all babies observed for 24 hours, measured in line with the clinical routine, was recorded.
18th and 24th hours
Heart rate peak
Time Frame: mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.
The heart rate of the baby receiving phototherapy was measured with a pulse oximeter device attached to the baby's wrist. The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed.
mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.
Oxygen saturation
Time Frame: mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.
The oxygen saturation of the baby receiving phototherapy was measured with a pulse oximeter device attached to the baby's wrist. The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed.
mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.
Bowel sounds
Time Frame: mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.
The bowel sounds of the baby receiving phototherapy was measured with a pulse oximeter device attached to the baby's wrist.The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed.
mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.
Stress level
Time Frame: mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.
Stress level in babies is evaluated with the "Newborn Stress Scale", whose Cronbach's alpha coefficient is between 0.65-0.81. The scale is a 3-point Likert type with a total of 24 items consisting of 8 sub-dimensions: facial expression, body color, respiration, activity level, consolability, muscle tone, extremities and posture. The items in the scale are graded according to the stress level and classified into 8 subgroups. Each subgroup is evaluated between 0-2 points, and a minimum of 0 and a maximum of 16 points are obtained from the scale. A score of 0 from the baby indicates that the baby's condition is stable and balanced. A high total score on the scale indicates that the baby's stress level is high. The evaluation will be done while the baby is in the mother's arms, 5 minutes after being placed on the phototherapy bed, and at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st and 24th hours after being placed on the phototherapy bed.
mother's arms, 5 minutes after the baby is placed in the phototherapy bed, 5 minutes after the baby is placed in the phototherapy bed at the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hitit University

Investigators

  • Principal Investigator: Ahu Pınar TURAN, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

June 29, 2024

First Submitted That Met QC Criteria

July 6, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 30, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulUC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I Don't Plan to Share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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