PainNCT05003661

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

A study testing Parents' Voice in people with Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 32 weeks and older
Conditions the study is for: Pain
What is being tested?: Parents' Voice
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteTaiwan
Study dates: 1 Jun 2021to 23 Feb 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 32 weeks and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Yang-Ming University
Taipei, 11221

Other trials in Taiwan

About this study

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.

Read the detailed description

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.

Conditions: Pain
Being tested: Parents' Voice
Keywords: Parents voice, Heel Puncture, Neonatal pain
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05003661
Study group	Role	What they receive
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. Receives: 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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Measure the NIPS at 10th minute after the heel puncture

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202123 Feb 2022

First posted12 Aug 2021
Study start1 Jun 2021
Primary completion26 Sep 2021
Study completion23 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05003661
Sponsor's protocol ID: YM109151F
Status last verified: Feb 2022
First submitted: 18 Jul 2021
Last updated: 7 Mar 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28751136
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.
PubMed 29579482
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.
PubMed 31421391
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.
PubMed 28580602
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.
PubMed 31350769

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of the Parents' Voice to Reduce the Heel Puncture Pain in High-Risk Neonates
ClinicalTrials.gov ID: NCT05003661
Acronym / sponsor ID: YM109151F
Conditions: Pain
Keywords: Parents voice, Heel Puncture, Neonatal pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: National Yang Ming Chiao Tung UniversityUniversity, hospital or other
Study start: 1 Jun 2021 (actual)
Primary completion: 26 Sep 2021 (actual)
Study completion: 23 Feb 2022 (actual)
First posted: 12 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Mother's voice	Experimental	Behavioral: Parents' VoiceNeonates 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.
Father's voice	Experimental	Behavioral: Parents' VoiceNeonates 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.
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.

Who may qualify

Ages: 32 weeks and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Parents' Voicethe intervention is recording of parents voice of reading children's book.	Behavioural	Father's voice, Mother's voice

Primary outcome

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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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

5 secondary outcomes

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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
Background: PubMed 28751136Alemdar 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.
Background: PubMed 29579482Alemdar 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.
Background: PubMed 31421391Carvalho 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.
Background: PubMed 28580602Chirico 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.
Background: PubMed 31350769Flacking 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Parents' Voice in people with Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05003661, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.