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

A

Akdeniz University

Status

Completed

Conditions

Pain, Acute

Treatments

Other: Mother voice
Other: White noise

Study type

Interventional

Funder types

Other

Identifiers

NCT05079594
Akdeniz Faculty of Nursing

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

1 hour to 1 month old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Routine Care Group
No Intervention group
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.
White Noise
Experimental group
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.
Treatment:
Other: White noise
Mother Voice
Experimental group
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.
Treatment:
Other: Mother voice

Trial contacts and locations

1

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Central trial contact

Uğur Gül

Data sourced from clinicaltrials.gov

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