Clinical trial NCT05079594: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: white noise
pain
Mother's voice
pain management
newborn
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CONFORTneo Scale
timeFrame: 1 year
Secondary outcomes:
measure: Heart rate peak
timeFrame: 1 year
measure: Oxygen saturation
timeFrame: 1 year
measure: Crying time
timeFrame: 1 year
measure: State Anxiety Scale score
timeFrame: 1 year
Other outcomes:
Locations:
city: Kepez
country: Turkey
facility: Akdeniz University
state: Antalya
Study officials:
affiliation: Akdeniz Universitesi, Akdeniz University Faculty of Nursing
name: Uğur Gül
role: PRINCIPAL_INVESTIGATOR
References:
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