Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000882820
Ethics application status
Approved
Date submitted
16/08/2012
Date registered
20/08/2012
Date last updated
20/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Talking to Babies in a Neonatal Intensive Care Unit: The impact of verbal soothing on measures of infant stress during painful procedures.
Scientific title
What is the effect of vocal soothing on preterm infant stress during painful procedures?
Secondary ID [1] 281038 0
Nil
Universal Trial Number (UTN)
U1111-1133-5470
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm infant stress 287171 0
Condition category
Condition code
Mental Health 287500 287500 0 0
Other mental health disorders
Reproductive Health and Childbirth 287532 287532 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All infants in this randomized controlled study will be exposed to the two study conditions – vocal soothing by a non parental adult during a routine heel prick procedure and no vocal soothing during a routine heel prick procedure. The vocal soothing will be offered by the primary investigator for this study. Vocal soothing will comprise matching vocal tone to the perceived infant emotional and physical experience, for example higher pitch, loud and with shorter sounds during the infant’s high arousal and a lower pitch, quieter, longer sounds during low arousal. The purpose of the intervention will be to communicate to the infant that an adult is there and is sympathetic towards them. The vocal soothing intervention will be offered for 1 hour over the time of the heel prick procedure and subsequent care activities. There will be at least 12 hours between conditions. The exact timing between conditions will vary as the second study will take place at the time of the infant's next scheduled heelprick blood test, which will be dependant on clinical need.
Intervention code [1] 285498 0
Prevention
Comparator / control treatment
Each infant will serve as their own control, receiving two heel prick blood tests, one with the soothing voice and one without the soothing voice. A previous study in the NICU that this research will be conducted in found that nurses did not vocally soothe infants in 95% (95% CI 0.6% - 17%) of heel prick procedures, so the control condition is akin to usual care in most cases.
Control group
Active

Outcomes
Primary outcome [1] 287754 0
Reduction of infant stress as assessed by salivary cortisol measures.
Timepoint [1] 287754 0
Salivary cortisol measures will be taken before the heel prick (baseline), 20 minutes following the heel prick (peak) and 50 minutes following the heel prick (recovery).
Secondary outcome [1] 298778 0
Reduction of behavioural measures of infant stress as measured by the Premature Infant Pain Profile (PIPP)
Timepoint [1] 298778 0
The PIPP score will be calculated for two minutes over the time of the heel prick blood test.
Secondary outcome [2] 298779 0
Reduction of infant stress as measured by heart rate variability. Heart rate will be measured by spectral analysis from an ECG signal.
Timepoint [2] 298779 0
Heart rate will be recorded continuously for up to 90 minutes over the time of the scheduled heel prick blood test. The exact length of time will include a period of baseline monitoring and will then depend on how long it takes the nurse to complete the heelprick, cares and feed for each baby.
Secondary outcome [3] 298780 0
Reduction of infant stress as measured by oxygen saturations. Oxygen saturations will be measured by oximetry using the compumetics sleep system.
Timepoint [3] 298780 0
Oxygen saturations will be recorded continuously for up to 90 minutes over the time of the scheduled heel prick blood test. The exact length of time will include a period of baseline monitoring and will then depend on how long it takes the nurse to complete the heelprick, cares and feed for each baby.

Eligibility
Key inclusion criteria
Non-surgical preterm infants born at 32-35 weeks gestational age, who are in their first two weeks of life, having the heel prick blood tests as part of their usual care and are thought to be healthy enough to participate by their nurse.
Minimum age
24 Hours
Maximum age
2 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants who are sedated, on respiratory support or have had a surgical procedure (surgical infants)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parents of eligible infants will be provided with a brief verbal overview by the principal investigator, as well as a written information sheet. The parents who have indicated an interest but have not consented, will be followed up by the principal investigator. The infants will be randomly allocated to the order of conditions by computer generation. Order allocation is not concealed, as the principal investigator has the order allocation list and assigns infants to it in the order of received signed consent forms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order allocation list was randomised using a computer package (R 2.15.1, R Foundation, Vienna, Austria) so that there were equal numbers of voice first/silent first infants in the list. The randomisation was done by blocks.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
63
Accrual to date
Final
Recruitment outside Australia
Country [1] 4487 0
New Zealand
State/province [1] 4487 0

Funding & Sponsors
Funding source category [1] 285822 0
Charities/Societies/Foundations
Name [1] 285822 0
Hawkes Bay Medical Research Foundation
Country [1] 285822 0
New Zealand
Funding source category [2] 285823 0
University
Name [2] 285823 0
University of Otago Fanny Evans Scholarship
Country [2] 285823 0
New Zealand
Primary sponsor type
University
Name
Department of Paediatrics and Child health
Address
University of Otago, Wellington
P O Box 7343
Wellington South 6242
Country
New Zealand
Secondary sponsor category [1] 284647 0
Hospital
Name [1] 284647 0
Neonatal Intensive Care Unit
Address [1] 284647 0
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
Country [1] 284647 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287839 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 287839 0
PO Box 5013
Lambton Quay
Wellington 6145
Ethics committee country [1] 287839 0
New Zealand
Date submitted for ethics approval [1] 287839 0
Approval date [1] 287839 0
13/08/2012
Ethics approval number [1] 287839 0
CEN/12/06/021

Summary
Brief summary
This study addresses the question of whether there are differences in measures of infant stress during a routine heel prick blood sampling procedure between two conditions: a non-parental adult talking empathically during the procedure compared with silence during the procedure.
Participating infants will be allocated to the two conditions, in random order. Each preterm infant will be 32 to 35 weeks gestational age at birth and will be having the heel prick blood tests as part of their usual treatment.
Behavioural measures of infant stress will be captured on video. Physiological measures of stress will be assessed through continuous monitoring of infant heart rate, breathing and blood oxygen levels during the study period as well as six cotton wool swab saliva samples per infant to measure the stress hormone cortisol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34582 0
Address 34582 0
Country 34582 0
Phone 34582 0
Fax 34582 0
Email 34582 0
Contact person for public queries
Name 17829 0
Lucie Zwimpfer
Address 17829 0
Department of Paediatrics and Child Health
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 17829 0
New Zealand
Phone 17829 0
+64-4-918 5062
Fax 17829 0
Email 17829 0
[email protected]
Contact person for scientific queries
Name 8757 0
Lucie Zwimpfer
Address 8757 0
Department of Paediatrics and Child Health
University of Otago, Wellington
PO Box 7343
Wellington South 6242
Country 8757 0
New Zealand
Phone 8757 0
+64-4-918 5062
Fax 8757 0
Email 8757 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.