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

NCT05003661 | Completed DMC

• 1 other identifier: YM109151F
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Parents voice; Heel Puncture; Neonatal pain

Outcome Measures

Primary Outcomes (15)

• Change in heart rate from 3rd minute before the heel puncture to 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

  Measure the heart rate at 3rd minute before the heel puncture

• Change in heart rate from 3rd minute before the heel puncture to 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.

  Measure the heart rate during the heel puncture

• Change in heart rate from 3rd minute before the heel puncture to 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

  Measure the heart rate at 1st minute after the heel puncture

• Change in heart rate from 3rd minute before the heel puncture to 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

  Measure the heart rate at 5th minute after the heel puncture

• Change in heart rate from 3rd minute before the heel puncture to 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

  Measure the heart rate at 10th minute after the heel puncture

• Change in respiratory rate from 3rd minute before the heel puncture to 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

  Measure the respiratory rate at 3rd minute before the heel puncture

• Change in respiratory rate from 3rd minute before the heel puncture to 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

  Measure the respiratory rate during the heel puncture

• Change in respiratory rate from 3rd minute before the heel puncture to 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

  Measure the respiratory rate at 1st minute after the heel puncture

• Change in respiratory rate from 3rd minute before the heel puncture to 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

  Measure the respiratory rate at 5th minute after the heel puncture

• Change in respiratory rate from 3rd minute before the heel puncture to 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

  Measure the respiratory rate at 10th minute after the heel puncture

• Change in oxygen saturation from 3rd minute before the heel puncture to 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

  Measure the oxygen saturation at 3rd minute before the heel puncture

• Change in oxygen saturation from 3rd minute before the heel puncture to 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

  Measure the oxygen saturation during the heel puncture

• Change in oxygen saturation from 3rd minute before the heel puncture to 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

  Measure the oxygen saturation at 1st minute after the heel puncture

• Change in oxygen saturation from 3rd minute before the heel puncture to 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

  Measure the oxygen saturation at 5th minute after the heel puncture

• Change in oxygen saturation from 3rd minute before the heel puncture to 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

  Measure the oxygen saturation at 10th minute after the heel puncture

Secondary Outcomes (5)

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

  Measure the NIPS at 3rd minute before the heel puncture

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

  Measure the NIPS during the heel puncture

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

  Measure the NIPS at 1st minute after the heel puncture

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

  Measure the NIPS at 5th minute after the heel puncture

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

  Measure the NIPS at 10th minute after the heel puncture

Study Arms (3)

Mother's voice

EXPERIMENTAL

Neonates receive the intervention that recording of mother's voice of reading children's book. And the pain of high-risk newborns was measured with the Heartbeat, Respiration, SPO2 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.

Behavioral: Parents' Voice

Father's voice

EXPERIMENTAL

Neonates receive the intervention that recording of father's voice of reading children's book. And the pain of high-risk newborns was measured with the Heartbeat, Respiration, SPO2 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.

Behavioral: Parents' Voice

control group

NO INTERVENTION

When the infants undergoing heel puncture procedure, the control group were under routine care. And the pain of high-risk newborns was measured with the Heartbeat, Respiration, SPO2 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.

Interventions

Parents' Voice BEHAVIORAL

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

Father's voice; Mother's voice

Eligibility Criteria

• Age: 32 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei, 11221, Taiwan

Location

Related Publications (5)

• Alemdar DK, Ozdemir FK. Effects of Covering the Eyes versus Playing Intrauterine Sounds on Premature Infants' Pain and Physiological Parameters during Venipuncture. J Pediatr Nurs. 2017 Nov-Dec;37:e30-e36. doi: 10.1016/j.pedn.2017.06.016. Epub 2017 Jul 24.

  PMID: 28751136 BACKGROUND

• Alemdar DK. Effect of recorded maternal voice, breast milk odor, and incubator cover on pain and comfort during peripheral cannulation in preterm infants. Appl Nurs Res. 2018 Apr;40:1-6. doi: 10.1016/j.apnr.2017.12.001. Epub 2017 Dec 14.

  PMID: 29579482 BACKGROUND

• Carvalho MES, Justo JMRM, Gratier M, Tome T, Pereira E, Rodrigues H. Vocal responsiveness of preterm infants to maternal infant-directed speaking and singing during skin-to-skin contact (Kangaroo Care) in the NICU. Infant Behav Dev. 2019 Nov;57:101332. doi: 10.1016/j.infbeh.2019.101332. Epub 2019 Aug 14.

  PMID: 31421391 BACKGROUND

• Chirico G, Cabano R, Villa G, Bigogno A, Ardesi M, Dioni E. Randomised study showed that recorded maternal voices reduced pain in preterm infants undergoing heel lance procedures in a neonatal intensive care unit. Acta Paediatr. 2017 Oct;106(10):1564-1568. doi: 10.1111/apa.13944. Epub 2017 Jul 5.

  PMID: 28580602 BACKGROUND

• Flacking R, Breili C, Eriksson M. Facilities for presence and provision of support to parents and significant others in neonatal units. Acta Paediatr. 2019 Dec;108(12):2186-2191. doi: 10.1111/apa.14948. Epub 2019 Sep 2.

  PMID: 31350769 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: August 12, 2021
• Study Start: June 1, 2021
• Primary Completion: September 26, 2021
• Study Completion: February 23, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)