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Completed

NCT Number: NCT05003661

The Effects of the Parents' Voice to Reduce the Heel Puncture Pain in High-Risk Neonates

High-risk neonates are forced to be separated from their parents due to hospitalization, and clinical medical treatment often causes pain and physical stress in high-risk newborns. Many literatures have confirmed that the mother's voice is positively helpful to the physiology of high-risk newborns, but few studies have been conducted on the father's voice. However, the parenting process is not only a link between the mother-child relationship, but also the impact of parental voice on high-risk newborns infants. Parent roles are expecting. The purpose of this study is to explore the effectiveness of parental voice intervention in high-risk newborns' heel puncture in reducing pain, and to further compare the mother and father's voice characteristics to the analysis of the pain degree of high-risk newborns.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

32 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, 11221, Taiwan

About this study

This study is a kind of experimental research design. The subjects are 105 infants with gestational weeks of more than 32 weeks. Randomly allocated are divided into one group of 35 in control group and 35 in each experimental group. On the third day after the birth of the high-risk newborns infant, the heel puncture times is lasted three minutes before the heel puncture to ten minutes after the puncture. The control groups only received general routine care, while the two parental experimental groups received the intervention that recording of parents voice of reading children's book. In the three groups, the pain of high-risk newborns was measured with the Heartbeat, Respiration and Neonatal Infant Pain Scale (NIPS) in three minutes before the heel puncture, during the puncture, and the first, fifth and tenth minutes after the puncture. It is hoped that the results of this study can help high-risk newborns to reduce pain with non-drug measures, and understand the influence of different voice characteristics on the development of infants, so as to provide future care personnel assisting parental role expectation and reference of clinical care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • High-risk newborns over 32 weeks of age.
  • Those who want to receive blood film collection for newborn screening on the third day of birth.
  • The incubator is used for care during the hospitalization.
  • The mother or father of the research subject can participate in the test all the way.
  • After explaining and reading the consent form, the parents of the research subjects agree to participate in the research and obtain written consent.

Exclusion criteria

  • Apgar Score is still below 7 in the fifth minute.
  • Being treated with a high-frequency positive pressure respirator.
  • Suffering from congenital diseases including: ear canal malformation, cerebral palsy, Down's syndrome, congenital cyanotic heart disease.
  • After the doctor's assessment, the patient should continue fasting due to the condition or restrict breastfeeding on demand.
  • Instability of blood glucose after birth requires close monitoring of blood glucose, and has received more than three (including) heel puncture experiences.
  • Birth injuries of the body due to the birth process, such as broken fetal head and broken collarbone.
  • Are receiving medical treatment with sedatives.

Treatment and study plan

Parents' Voice

Behavioral

the intervention is recording of parents voice of reading children's book.

Primary outcomes

  1. Change in heart rate from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the heart rate at 3rd minute before the heel puncture

    Measure the heart rate at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  2. Change in heart rate from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the heart rate during the heel puncture

    Measure the heart rate at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture.

  3. Change in heart rate from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the heart rate at 1st minute after the heel puncture

    Measure the heart rate at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  4. Change in heart rate from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the heart rate at 5th minute after the heel puncture

    Measure the heart rate at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  5. Change in heart rate from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the heart rate at 10th minute after the heel puncture

    Measure the heart rate at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  6. Change in respiratory rate from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the respiratory rate at 3rd minute before the heel puncture

    Measure the respiratory rate at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  7. Change in respiratory rate from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the respiratory rate during the heel puncture

    Measure the respiratory rate at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  8. Change in respiratory rate from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the respiratory rate at 1st minute after the heel puncture

    Measure the respiratory rate at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  9. Change in respiratory rate from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the respiratory rate at 5th minute after the heel puncture

    Measure the respiratory rate at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  10. Change in respiratory rate from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the respiratory rate at 10th minute after the heel puncture

    Measure the respiratory rate at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  11. Change in oxygen saturation from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the oxygen saturation at 3rd minute before the heel puncture

    Measure the oxygen saturation at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  12. Change in oxygen saturation from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the oxygen saturation during the heel puncture

    Measure the oxygen saturation at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  13. Change in oxygen saturation from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the oxygen saturation at 1st minute after the heel puncture

    Measure the oxygen saturation at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  14. Change in oxygen saturation from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the oxygen saturation at 5th minute after the heel puncture

    Measure the oxygen saturation at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

  15. Change in oxygen saturation from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the oxygen saturation at 10th minute after the heel puncture

    Measure the oxygen saturation at 3rd minute before the heel puncture, during, and at 1st, 5th and 10th minutes after the heel puncture

Secondary outcomes

  1. Change in respond of pain from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the NIPS at 3rd minute before the heel puncture

    Pain response assessed using the Neonatal Infants Pain Scale (NIPS), The evaluation indicators include 6 behavior indicators: facial expression, crying, breathing pattern, arms, legs and awakening status, except that the crying score is divided into three points (0, 1, 2 points), and the rest are two points (0 , 1 point), the total score is 0-7 points, the higher the score, the more serious the pain.

  2. Change in respond of pain from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the NIPS during the heel puncture

    Pain response assessed using the Neonatal Infants Pain Scale (NIPS), The evaluation indicators include 6 behavior indicators: facial expression, crying, breathing pattern, arms, legs and awakening status, except that the crying score is divided into three points (0, 1, 2 points), and the rest are two points (0 , 1 point), the total score is 0-7 points, the higher the score, the more serious the pain.

  3. Change in respond of pain from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the NIPS at 1st minute after the heel puncture

    Pain response assessed using the Neonatal Infants Pain Scale (NIPS), The evaluation indicators include 6 behavior indicators: facial expression, crying, breathing pattern, arms, legs and awakening status, except that the crying score is divided into three points (0, 1, 2 points), and the rest are two points (0 , 1 point), the total score is 0-7 points, the higher the score, the more serious the pain.

  4. Change in respond of pain from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the NIPS at 5th minute after the heel puncture

    Pain response assessed using the Neonatal Infants Pain Scale (NIPS), The evaluation indicators include 6 behavior indicators: facial expression, crying, breathing pattern, arms, legs and awakening status, except that the crying score is divided into three points (0, 1, 2 points), and the rest are two points (0 , 1 point), the total score is 0-7 points, the higher the score, the more serious the pain.

  5. Change in respond of pain from 3rd minute before the heel puncture to 10th minute after the heel puncture

    Time frame: Measure the NIPS at 10th minute after the heel puncture

    Pain response assessed using the Neonatal Infants Pain Scale (NIPS), The evaluation indicators include 6 behavior indicators: facial expression, crying, breathing pattern, arms, legs and awakening status, except that the crying score is divided into three points (0, 1, 2 points), and the rest are two points (0 , 1 point), the total score is 0-7 points, the higher the score, the more serious the pain.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 12, 2021
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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