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Premature Newborn Pain Management: The Effects of Breast Milk Odor and White Noise

Primary Purpose

Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breast milk olfactory stimulation
White noise auditory stimulation
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Newborn, Pain, Breast milk odor, White noise, Heel lance

Eligibility Criteria

undefined - 7 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • gestational age between 34 and 37 weeks
  • birth weight over 1500 g
  • Taking blood from the heel for the purpose of measuring blood sugar
  • Starting feeding with breast milk
  • Being hospitalized in Ankara University Faculty of Medicine Cebeci Application and Research Hospital

Exclusion Criteria:

  • Having a chromosomal abnormality
  • Presence of neonatal seizures
  • Presence of intracranial bleeding (grade III-IV)
  • Presence of craniofacial malformation
  • Presence of congenital hearing loss
  • Babies with perinatal asphyxia
  • Babies using sedatives, muscle relaxants and antiepileptics
  • Babies whose mothers have a history of substance use The baby is agitated

Sites / Locations

  • Ankara UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Breast Milk Odor Group

White Noise Group

Arm Description

Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the control group. Babies in the control group will not be allowed to smell breast milk or listen to white noise.The newborn in the control group will continue to receive routine care.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure.

Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the breast milk odor group.Before the intervention, 3 ml of breast milk will be dripped into sterile sponge and the sponge will be placed within 3 cm of the newborn's nose.Babies in this group will start to smell their mother's milk 5 minutes before the procedure and will continue to smell for 5 minutes after the procedure.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure.

Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the white noise listening group.Before the intervention , a bluetooth speaker will be placed at the baby's feet. The speaker will be connected to the phone and the sound level will be adjusted to 50 decibels by means of a decibel meter. The baby will be started to listen to white noise 5 minutes before the procedure.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure.

Outcomes

Primary Outcome Measures

Neonatal Pain
Premature Infant Pain Profile-Revised The scale includes seven criteria. Facial expressions (frown, squint, prominence of the nasolabial groove) represent three criteria. Two additional criteria are changes in heart rate and reduction in oxygen saturation. The remaining criteria are gestational week and behavioral status (active-awake, quiet-wake, active-asleep and quiet-sleeping). According to the scale, the highest score is 21 for prematures and 18 for term newborns. According to the scale scoring, 0-6 points indicate mild pain, 7-12 points moderate pain, and 13-21 points severe pain in a premature baby.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2022
Last Updated
December 26, 2022
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT05444608
Brief Title
Premature Newborn Pain Management: The Effects of Breast Milk Odor and White Noise
Official Title
A Comparative Evaluation of the Effects of Using Breast Milk Odor and Listening to White Noise During Heel Lance in Premature Newborn on Pain Management: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
May 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will conduct to evaluate the effect of using white noise and breast milk odor on pain during heel lance procedure in premature newborns. This study is a randomized controlled trial. The study will conduct with premature newborns who were born between 34 and 37 weeks of gestation. The premature newborns will be divided into three groups by application of pain relief methods during heel lance to check blood sugar in newborns. These groups can be described as breast milk odor (n=22), white noise (n=22) and control group (n=22). The intervention will start 5 minutes before the procedure and last 5 minutes after the procedure. The infants will be recorded with a video camera by researcher before, during, and after the procedure. Premature Infant Pain Profile Revised (PIPP-R) will be used for pain grading.
Detailed Description
The sense of pain develops in infants after the 20th gestational weeks with the initiation of communication between the cortex and the thalamus. Babies in the newborn period can respond physiologically, behaviorally and hormonal to painful stimuli which they experienced. Responses that emerge as a result of pain experience may adversely affect the current state of the newborn and its growth and development in the long term. One of the painful procedures that the newborn is frequently exposed to at the beginning of the extra-uterine life is blood collection from the heel. Pharmacological and non-pharmacological methods can be applied to alleviate the pain sensation experienced by newborns during these procedures. The existence of possible side effects of pharmacological methods has led to need to use non-pharmacological methods more effectively. In this study, it was aimed to investigate the effectiveness of breast milk odor and white noise, which are non-pharmacological methods, to the pain caused by heel puncture. Main hypothesizes of the study can be listed as: H10: Smelling breast milk during heel puncture is not effective in reducing procedural pain in preterm newborns. H11: Smelling breast milk during heel puncture is effective in reducing procedural pain in preterm newborns H20: Listening to white noise during heel puncture is not effective in reducing procedural pain in preterm newborns. H21: Listening to white noise during heel puncture is effective in reducing procedural pain in preterm newborns. The population of the study will consist of preterm babies born between 34-37 weeks of gestation, who were hospitalized in the Neonatal Intensive Care Unit of Ankara University Faculty of Medicine, Cebeci Application and Research Hospital, between June 2022 and October 2022 and for whom heel blood sampling is requested.The sample of the study will consist of 66 (white noise=22, breast milk odor=22, control=22) infants who met the case selection criteria and were randomly assigned to groups. Babies will be made to listen to white noise or smell breast milk for 5 minutes before the heel blood collection procedure, during the procedure and 5 minutes after the procedure in accordance with the group they are involved. Only routine nursing care will be applied to the control group, no additional intervention. All the infants in three different groups will be recorded by video camera. Recording will start 5 minutes before the heel lance procedure and continue during the procedure and 5 minutes after the procedure. Pain assessments will be made by another researcher through video recordings. Newborns pain will evaluate with the PIPP-R pain scale 5 minutes before procedure (at the beginnings of intervention), 2 minutes before procedure, during procedure and 5 minutes after the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Newborn, Pain, Breast milk odor, White noise, Heel lance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This randomized controlled experimental study will performing to investigate the effect of smelling breast milk and listening to white noise in reducing pain during heel puncture
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the control group. Babies in the control group will not be allowed to smell breast milk or listen to white noise.The newborn in the control group will continue to receive routine care.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure.
Arm Title
Breast Milk Odor Group
Arm Type
Experimental
Arm Description
Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the breast milk odor group.Before the intervention, 3 ml of breast milk will be dripped into sterile sponge and the sponge will be placed within 3 cm of the newborn's nose.Babies in this group will start to smell their mother's milk 5 minutes before the procedure and will continue to smell for 5 minutes after the procedure.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure.
Arm Title
White Noise Group
Arm Type
Experimental
Arm Description
Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the white noise listening group.Before the intervention , a bluetooth speaker will be placed at the baby's feet. The speaker will be connected to the phone and the sound level will be adjusted to 50 decibels by means of a decibel meter. The baby will be started to listen to white noise 5 minutes before the procedure.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure.
Intervention Type
Behavioral
Intervention Name(s)
Breast milk olfactory stimulation
Intervention Description
Before the intervention, 3 ml of breast milk will be dripped into sterile sponge and the sponge will be placed within 3 cm of the newborn's nose.Babies in this group will start to smell their mother's milk 5 minutes before the procedure and will continue to smell for 5 minutes after the procedure.
Intervention Type
Behavioral
Intervention Name(s)
White noise auditory stimulation
Intervention Description
Before the intervention, a bluetooth speaker will be placed at the baby's feet. The speaker will be connected to the phone and the sound level will be adjusted to 50 decibels by means of a decibel meter. The baby will be started to listen to white noise 5 minutes before the procedure and will continue to listen for 5 minutes after the procedure.
Primary Outcome Measure Information:
Title
Neonatal Pain
Description
Premature Infant Pain Profile-Revised The scale includes seven criteria. Facial expressions (frown, squint, prominence of the nasolabial groove) represent three criteria. Two additional criteria are changes in heart rate and reduction in oxygen saturation. The remaining criteria are gestational week and behavioral status (active-awake, quiet-wake, active-asleep and quiet-sleeping). According to the scale, the highest score is 21 for prematures and 18 for term newborns. According to the scale scoring, 0-6 points indicate mild pain, 7-12 points moderate pain, and 13-21 points severe pain in a premature baby.
Time Frame
up to 7 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: gestational age between 34 and 37 weeks birth weight over 1500 g Taking blood from the heel for the purpose of measuring blood sugar Starting feeding with breast milk Being hospitalized in Ankara University Faculty of Medicine Cebeci Application and Research Hospital Exclusion Criteria: Having a chromosomal abnormality Presence of neonatal seizures Presence of intracranial bleeding (grade III-IV) Presence of craniofacial malformation Presence of congenital hearing loss Babies with perinatal asphyxia Babies using sedatives, muscle relaxants and antiepileptics Babies whose mothers have a history of substance use The baby is agitated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burcu OTLU, master student
Phone
+90 555 829 08 64
Email
burcuotlu@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Figen Işık ESENAY, Assistant Professor
Email
fesenay@yahoo.com
Facility Information:
Facility Name
Ankara University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Premature Newborn Pain Management: The Effects of Breast Milk Odor and White Noise

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