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

December 3, 2023 updated by: Uğur Gül, Akdeniz University

Investigation of Infant Comfort Levels and Mothers' Anxiety Levels in Non-pharmacological Maternal Voice and White Noise Methods in Heel Blood Procedure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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 Contact

Study Locations

  • Turkey
    • Antalya
      • Kepez, Antalya, Turkey
        • Akdeniz University

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

1 hour to 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine Care Group
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.
Experimental: White Noise
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.
Other: White noise

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.
Experimental: Mother Voice
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.
Other: Mother voice
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CONFORTneo Scale
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate peak
Time Frame: 1 year
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.
1 year
Oxygen saturation
Time Frame: 1 year
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.
1 year
Crying time
Time Frame: 1 year
The crying time of the newborn will be recorded by the researcher. Time to return to baseline values
1 year
State Anxiety Scale score
Time Frame: 1 year

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".
1 year

Collaborators and Investigators

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

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Uğur Gül, Akdeniz Universitesi, Akdeniz University Faculty of Nursing

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)

March 15, 2021

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 16, 2022

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Akdeniz Faculty of Nursing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The identity of the patient will not be shared to ensure confidentiality.

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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