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Trial registered on ANZCTR


Registration number
ACTRN12616001229460
Ethics application status
Approved
Date submitted
13/06/2016
Date registered
5/09/2016
Date last updated
5/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Magnific Study- A randomised controlled trial of magnetic non-invasive acupuncture for infant comfort for heel prick tests.
Scientific title
The Magnific Study - Magnetic Non-Invasive acupuncture for Infant Comfort during heel prick test in Neonatal Intensive Care Unit (NICU)
Secondary ID [1] 289430 0
Nil
Universal Trial Number (UTN)
U1111-1184-2568
Trial acronym
Magnific
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Intensive Care 299109 0
Procedural pain 299110 0
Condition category
Condition code
Alternative and Complementary Medicine 299135 299135 0 0
Other alternative and complementary medicine
Anaesthesiology 299136 299136 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnets or placebos will be placed at five ear points (both ears) at least 2 hours before a heel prick. The magnets or placebos will be left for three days during which the infant will be assessed for his/her response to the heel prick with the PIPP (Premature Infant Pain Profile) score. After three days, the magnets will be removed and the infant will be discharged from the study. The magnets are embedded in a sticker. The placebos are stickers with the magnets removed. A "bump" is created on the surface of the sticker with liquid paper to mask the magnet. The magnet will be placed either by an acupuncturist or by a research officer who is trained by the acupuncturist. The stickers will be checked every day by the site research officer and replaced if they have fallen off before the end of the three day period.
Intervention code [1] 295020 0
Treatment: Other
Comparator / control treatment
Babies in the placebo group will have stickers without magnets placed on their ears.
Control group
Placebo

Outcomes
Primary outcome [1] 298611 0
Primary outcome is the PIPP score during and 1 hour after the heel prick.
Timepoint [1] 298611 0
Before (baseline), during (at heel prick) and 1 hour after the heel prick
Secondary outcome [1] 324715 0
Medical record review of whether sucrose was provided at any time before, during or after the heel prick.
Timepoint [1] 324715 0
After completion of each heel prick

Eligibility
Key inclusion criteria
Infants who require a heel prick for blood collection in the NICU. Babies will be matched by gender, gestation and age.
Minimum age
No limit
Maximum age
4 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Babies who need sedation and analgesia for other reasons e.g. post-operative analgesia or who cannot express pain (e.g. muscle relaxed, intubated and ventilated).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The attending clinician will be approached by the site investigator to determine if the infant is eligible for the study. If eligible, the site investigator will determine randomisation to either magnet or placebo in a code that is concealed within sealed opaque envelopes and generated by random computerised sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size is calculated on PIPP scores as this dictates how the pain of an infant is managed in an NICU. 40 infants are required to achieve a 20% decrease in mean PIPP score in response to a painful procedure will require, with 80% power and 5% alpha.

Statistical analysis for the primary endpoints of this study will be conducted by the intention to treat principle. Analyses will be based on the GEE extension to the generalized linear model with each measure treated as a binary outcome using a logit link to evaluate the effect of treatment controlling for gestational age stratum. Comparison between the two treatment arms (magnet and no magnet) will be assessed using analysis of variance (ANOVA) models and comparable non-parametric tests for continuous variables and generalized linear models and contingency table procedures (Chi square tests) for categorical variables, controlling for gestational age strata. Linear and generalized regression models will adjust for potential confounders (i.e., demographic and clinical data, site) and evaluate the independent association between the use of magnets or no magnet on pain scores. For each outcome measure, model-based approaches will examine whether treatment effects differ across the two gestational age strata, and if so will evaluate treatment effect within strata, although the power to detect such differences is limited.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6542 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 14129 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 293804 0
Hospital
Name [1] 293804 0
Royal Hospital for Women
Address [1] 293804 0
Royal Hospital for Women
Barker Street
Randwick
NSW
2031
Australia
Country [1] 293804 0
Australia
Primary sponsor type
Hospital
Name
Royal Hospital for Women
Address
Royal Hospital for Women
Barker Street
Randwick
NSW
2031
Australia
Country
Australia
Secondary sponsor category [1] 292636 0
None
Name [1] 292636 0
Address [1] 292636 0
Country [1] 292636 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295236 0
South Eastern Sydney Local Health District
Ethics committee address [1] 295236 0
Prince of Wales Hospital
High Street
Randwick NSW 2031
Ethics committee country [1] 295236 0
Australia
Date submitted for ethics approval [1] 295236 0
29/10/2015
Approval date [1] 295236 0
21/07/2016
Ethics approval number [1] 295236 0

Summary
Brief summary
The Magnific Study aims to determine if the use of magnetic acupuncture will reduce the stress and pain experienced by infants in newborn intensive care units in response to a very common painful stimulus, heel pricks for blood collection. Babies will be randomised to having 5 magnetic stickers or placebos placed on each ear for 3 days. During this time, the baby's response to a heel prick will be measured using a widely used pain scale, the PIPP score. After three days, the stickers (with and without magnets) will be removed and the PIPP scores will be examined.
Trial website
To be arranged
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66650 0
A/Prof Ju Lee Oei
Address 66650 0
Department of Newborn Care
The Royal Hospital for Women
Barker Street
Randwick NSW 2031
Country 66650 0
Australia
Phone 66650 0
+61 2 9382 6111
Fax 66650 0
+61 2 9382 6191
Email 66650 0
j.oei@unsw.edu.au
Contact person for public queries
Name 66651 0
A/Prof Ju Lee Oei
Address 66651 0
Department of Newborn Care
The Royal Hospital for Women
Barker Street
Randwick NSW 2031
Country 66651 0
Australia
Phone 66651 0
+61 2 9382 6111
Fax 66651 0
+61 2 9382 6191
Email 66651 0
j.oei@unsw.edu.au
Contact person for scientific queries
Name 66652 0
A/Prof Ju Lee Oei
Address 66652 0
Department of Newborn Care
The Royal Hospital for Women
Barker Street
Randwick NSW 2031
Country 66652 0
Australia
Phone 66652 0
+61 2 9382 6111
Fax 66652 0
+61 2 9382 6191
Email 66652 0
j.oei@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results