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The Effects of Auditory Interventions on Comfort and Mothers' Anxiety in Newborns

Primary Purpose

Pain, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mother voice
White noise
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Acute focused on measuring white noise, pain, Mother's voice, pain management, newborn

Eligibility Criteria

1 Hour - 1 Month (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Newborns whose postnatal age is between 1-5 days,
  2. 38-42. newborns born between gestational weeks,
  3. Healthy newborns,
  4. Babies of mothers without diabetes,
  5. Newborns who were not given any opioid and non-opioid drugs before the application,
  6. Newborns who have been fed at least 30 minutes ago,
  7. Newborns without any painful interventions other than vitamin K and Hepatitis B injections will be included.
  8. Mothers who can speak and understand Turkish,
  9. The mothers and their babies who accepted to participate in the study and whose written consent form was obtained from them will be included in the study.

Exclusion Criteria:

  1. Connected to a mechanical ventilator,
  2. Having a neurological disorder,
  3. Congenital anomaly,
  4. Having hyperglycemia,
  5. Having undergone a surgical procedure,
  6. Substance addicted mother and her baby,
  7. If the lancet cannot be inserted and removed at once, the baby will be excluded from the study.
  8. Infants, despite meeting the criteria, will be excluded from the study if the heel blood collection takes more than 2 minutes in total, the procedure is disrupted by someone entering the room loudly, or the mother changes the position of the baby.
  9. Mothers with a special condition that will cause difficulties in understanding and perception will be excluded from the study.

Sites / Locations

  • Akdeniz UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Routine Care Group

White Noise

Mother Voice

Arm Description

Before the application, the families will be informed by the researcher and the 'Informed Consent Form' will be signed. After the heel blood procedure, when the baby starts to cry, comfort will be provided with gentle touches. For ethical reasons, routine care will be provided when the baby cries.

Since white noise is a humming and continuous monotonous sound, it is similar to the sound in the womb. It will be explained that this sound is very similar to the sound that the baby hears in the mother's womb by making the white noise recordings listen to the mothers who will have their babies listen to white noise. by Orhan Osman; Dr. From the album 'Kolik', which was created by making use of the album 'The Happiest Baby' prepared by Harvey Karp, which consists only of uterus sounds; The song 'Don't Let Your Baby Cry, PT.2' will be played to babies. In addition, infants will be excluded from the study even though they meet the criteria, if they are not sedated, the procedure takes more than 2 minutes, the procedure is disrupted because someone enters the room loudly, or the mother changes the baby's position.

Auditory responses, fetal age 26-28. It develops in the auditory cortex and brain stem in weeks. Hearing is one of the first senses a fetus develops and is 24-33. can recognize and remember the mother's voice after weeks. The fetus memorizes the musical characteristics of the mother's voice, like tone, by listening to it. It is stated that newborns exposed to their own mother's voice have a lower heart rate, higher sucking rate, a more relaxed appearance, and less crying and body movements.

Outcomes

Primary Outcome Measures

CONFORTneo Scale
The Neonatal Comfort Behavior Scale consists of 7 items: muscle tone, alertness, facial tension, calmness/agitation, body movements, respiratory response, and crying. Since "respiratory response" was scored in infants connected to mechanical ventilator and "crying" was scored in spontaneously breathing infants, the total score was calculated over 6 items. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6, and the highest score is 30.On this scale, if the total score of the scale is between 6-13, the baby is comfortable. If the total score is between 14-30, the baby has pain or distress and needs interventions to relieve him.

Secondary Outcome Measures

Heart rate peak
Peak heart rate will be measured with the "Nellcor Oximax N-560 Quick Guide" brand device. Nellcor saturation probe will be attached to the left foot of the newborn and the measurement will be made by the investigator.
Oxygen saturation
Oxygen saturation will be measured with the "Nellcor Oximax N-560 Quick Guide" brand device. Nellcor saturation probe will be attached to the left foot of the newborn and the measurement will be made by the investigator.
Crying time
The crying time of the newborn will be recorded by the researcher. Time to return to baseline values
State Anxiety Scale score
In this study, the "State Anxiety" section of the State-Trait Anxiety Inventory developed by Spielberg et al. in 1970 will be used to determine the state anxiety levels of mothers. In the evaluation, 0-19 points are interpreted as "no anxiety", 20-39 points as "mild anxiety", 40-59 points as "moderate anxiety", 60-79 points as "severe anxiety" and 80 points as "panic value".

Full Information

First Posted
October 4, 2021
Last Updated
March 23, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05079594
Brief Title
The Effects of Auditory Interventions on Comfort and Mothers' Anxiety in Newborns
Official Title
Investigation of Infant Comfort Levels and Mothers' Anxiety Levels in Non-pharmacological Maternal Voice and White Noise Methods in Heel Blood Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz 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
The heel blood procedure for newborn screening is done for almost all babies within the first 48 hours of birth. It is stated that non-pharmacological methods in reducing pain during the heel blood collection process are simple, effective, free, and very cost-effective. Studies have shown that auditory interventions (such as mother's voice, white noise) used in invasive procedures distract the infant and create a cognitive strategy for pain control. According to this information, one aim of the study is to determine the effect of the mother's voice and white noise, which are non-pharmacological methods, on the comfort level of the baby in the heel blood procedure. It is thought that especially acute painful procedures applied to infants will reduce the level of stress and anxiety in parents. Another aim of this study is to determine the effect of a mother's voice and white noise, which are non-pharmacological methods, on the state anxiety levels of mothers in the heel blood collection process.
Detailed Description
The heel blood procedure for newborn screening is done for almost all babies within the first 48 hours of birth. The heel blood procedure, which is widely used for the diagnosis and follow-up of various diseases, causes acute pain in infants. It is stated that non-pharmacological methods in reducing pain during the heel blood collection process are simple, effective, free, and very cost-effective. For example, non-pharmacological methods such as breastfeeding, skin-to-skin contact, oral sucrose, mother's voice, and white noise are stated to be effective in reducing acute pain. Clinical practice guidelines recommend the use of non-pharmacological methods in acute painful procedures. Studies have shown that auditory interventions (such as mother's voice, white noise) used in invasive procedures distract the infant and create a cognitive strategy for pain control. According to this information, one aim of the study is to determine the effect of the mother's voice and white noise, which are non-pharmacological methods, on the comfort level of the baby in the heel blood procedure. Few studies have targeted parents of newborn infants, although studies to date have shown that parents want to be more involved in their infants' pain management. Parents reported that they wanted to learn more about pain management strategies, they wanted to play a role in the relaxation of their babies, and they hoped for more opportunities to participate in the care of their babies in the hospital. It is thought that especially acute painful procedures applied to infants will reduce the level of stress and anxiety in parents. In addition, one study reported that when parents are given information to help reduce their baby's pain, they accept painful procedures such as heel prick more easily and feel calmer. In the light of this information, another aim of this study is to determine the effect of a mother's voice and white noise, which are non-pharmacological methods, on the state anxiety levels of mothers in the heel blood collection process.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
white noise, pain, Mother's voice, pain management, newborn

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine Care Group
Arm Type
No Intervention
Arm Description
Before the application, the families will be informed by the researcher and the 'Informed Consent Form' will be signed. After the heel blood procedure, when the baby starts to cry, comfort will be provided with gentle touches. For ethical reasons, routine care will be provided when the baby cries.
Arm Title
White Noise
Arm Type
Experimental
Arm Description
Since white noise is a humming and continuous monotonous sound, it is similar to the sound in the womb. It will be explained that this sound is very similar to the sound that the baby hears in the mother's womb by making the white noise recordings listen to the mothers who will have their babies listen to white noise. by Orhan Osman; Dr. From the album 'Kolik', which was created by making use of the album 'The Happiest Baby' prepared by Harvey Karp, which consists only of uterus sounds; The song 'Don't Let Your Baby Cry, PT.2' will be played to babies. In addition, infants will be excluded from the study even though they meet the criteria, if they are not sedated, the procedure takes more than 2 minutes, the procedure is disrupted because someone enters the room loudly, or the mother changes the baby's position.
Arm Title
Mother Voice
Arm Type
Experimental
Arm Description
Auditory responses, fetal age 26-28. It develops in the auditory cortex and brain stem in weeks. Hearing is one of the first senses a fetus develops and is 24-33. can recognize and remember the mother's voice after weeks. The fetus memorizes the musical characteristics of the mother's voice, like tone, by listening to it. It is stated that newborns exposed to their own mother's voice have a lower heart rate, higher sucking rate, a more relaxed appearance, and less crying and body movements.
Intervention Type
Other
Intervention Name(s)
Mother voice
Intervention Description
Five minutes before the procedure, the mother's voice recording will be played to the baby and the speaker will be placed 30 cm away from the baby. The baby's comfort level will be evaluated by the researcher using the "Neonatal Comfort Behavior Scale" 2 minutes before the procedure begins. Physiological values of the baby will be noted by the researcher 1 minute before the procedure.As soon as the heel blood procedure is completed, the baby's physiological values and comfort level will be noted by the "Newborn Comfort Behavior Scale" by the researcher. After the procedure, the recording will continue to be played until the baby's mother's voice returns to the basal values. Physiological values and comfort levels of the baby will be noted by the researcher 1 minute and 2 minute after the procedure. 2 minutes after the procedure, the baby's comfort level will be evaluated by the researcher using the "Neonatal Comfort Behavior Scale".
Intervention Type
Other
Intervention Name(s)
White noise
Intervention Description
Before Operation The decibel meter will be set to an average of 50-60 dB and the speakers will be played at a distance of 30 cm. Intervention in this group will be made at the elevation. White noise will be played five minutes before the procedure.The baby's comfort level and physiological values will be evaluated by the researcher using the "Neonatal Comfort Behavior Scale" 2 minutes before the procedure begins. Order of Operation As soon as the heel blood procedure is completed, the baby's physiological values and comfort level will be noted by the "Newborn Comfort Behavior Scale" by the researcher. Post-Processing After the procedure, white noise will continue to be listened to until the baby's physiological values return to basal values. Physiological values and baby's comfort level of the baby will be noted by the researcher 1 minute and 2 minute after the heel blood collection is completed.
Primary Outcome Measure Information:
Title
CONFORTneo Scale
Description
The Neonatal Comfort Behavior Scale consists of 7 items: muscle tone, alertness, facial tension, calmness/agitation, body movements, respiratory response, and crying. Since "respiratory response" was scored in infants connected to mechanical ventilator and "crying" was scored in spontaneously breathing infants, the total score was calculated over 6 items. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6, and the highest score is 30.On this scale, if the total score of the scale is between 6-13, the baby is comfortable. If the total score is between 14-30, the baby has pain or distress and needs interventions to relieve him.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Heart rate peak
Description
Peak heart rate will be measured with the "Nellcor Oximax N-560 Quick Guide" brand device. Nellcor saturation probe will be attached to the left foot of the newborn and the measurement will be made by the investigator.
Time Frame
1 year
Title
Oxygen saturation
Description
Oxygen saturation will be measured with the "Nellcor Oximax N-560 Quick Guide" brand device. Nellcor saturation probe will be attached to the left foot of the newborn and the measurement will be made by the investigator.
Time Frame
1 year
Title
Crying time
Description
The crying time of the newborn will be recorded by the researcher. Time to return to baseline values
Time Frame
1 year
Title
State Anxiety Scale score
Description
In this study, the "State Anxiety" section of the State-Trait Anxiety Inventory developed by Spielberg et al. in 1970 will be used to determine the state anxiety levels of mothers. In the evaluation, 0-19 points are interpreted as "no anxiety", 20-39 points as "mild anxiety", 40-59 points as "moderate anxiety", 60-79 points as "severe anxiety" and 80 points as "panic value".
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Newborns whose postnatal age is between 1-5 days, 38-42. newborns born between gestational weeks, Healthy newborns, Babies of mothers without diabetes, Newborns who were not given any opioid and non-opioid drugs before the application, Newborns who have been fed at least 30 minutes ago, Newborns without any painful interventions other than vitamin K and Hepatitis B injections will be included. Mothers who can speak and understand Turkish, The mothers and their babies who accepted to participate in the study and whose written consent form was obtained from them will be included in the study. Exclusion Criteria: Connected to a mechanical ventilator, Having a neurological disorder, Congenital anomaly, Having hyperglycemia, Having undergone a surgical procedure, Substance addicted mother and her baby, If the lancet cannot be inserted and removed at once, the baby will be excluded from the study. Infants, despite meeting the criteria, will be excluded from the study if the heel blood collection takes more than 2 minutes in total, the procedure is disrupted by someone entering the room loudly, or the mother changes the position of the baby. Mothers with a special condition that will cause difficulties in understanding and perception will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uğur Gül
Phone
+90 507 528 59 90
Email
ugurgul6061@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uğur Gül
Organizational Affiliation
Akdeniz Universitesi, Akdeniz University Faculty of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akdeniz University
City
Kepez
State/Province
Antalya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uğur Gül
Phone
0(507) 528 59 90
Ext
2923
Email
ugurgul6061@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The identity of the patient will not be shared to ensure confidentiality.
Citations:
PubMed Identifier
26505851
Citation
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Results Reference
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Benoit B, Campbell-Yeo M, Johnston C, Latimer M, Caddell K, Orr T. Staff Nurse Utilization of Kangaroo Care as an Intervention for Procedural Pain in Preterm Infants. Adv Neonatal Care. 2016 Jun;16(3):229-38. doi: 10.1097/ANC.0000000000000262.
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Citation
Campbell-Yeo M, Fernandes A, Johnston C. Procedural pain management for neonates using nonpharmacological strategies: part 2: mother-driven interventions. Adv Neonatal Care. 2011 Oct;11(5):312-8; quiz pg 319-20. doi: 10.1097/ANC.0b013e318229aa76.
Results Reference
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Results Reference
result

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The Effects of Auditory Interventions on Comfort and Mothers' Anxiety in Newborns

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