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Trial registered on ANZCTR
Registration number
ACTRN12617001570370
Ethics application status
Approved
Date submitted
1/11/2017
Date registered
22/11/2017
Date last updated
10/07/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
At their fingertips: The effects of child-led distraction using a tablet computer on children’s distress and pain during painful medical procedures; a randomised controlled trial.
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Scientific title
At their fingertips: The effects of child-led distraction using a tablet computer on children’s distress and pain during painful medical procedures; a randomised controlled trial.
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Secondary ID [1]
293256
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None
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Universal Trial Number (UTN)
U1111-1204-5677
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Distress
305306
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Pain
305307
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Anxiety
305308
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Condition category
Condition code
Mental Health
304610
304610
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0
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Anxiety
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Anaesthesiology
304659
304659
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study will be conducted in a Western Australian tertiary paediatric hospital within the Ambulatory Care Day-stay Facility (ACDF) by a Registered Nurse/Researcher. A randomised controlled trial with one control group and one experimental group will be undertaken. The experimental group will receive ‘standard care’ from their parents and healthcare professionals and the distraction of the tablet computer (Apple iPad) to self-lead their own distraction. The tablet computer will be offered to the child upon entering the treatment room in view of the intravenous cannulation procedure. The tablet computer will be provided 5 minutes prior to the commencement of the procedure to allow the child time to familiarise themselves with the tablet computer and decide on a distraction. The tablet will be returned on completion of the procedure. A wide number of age-specific applications will be uploaded onto the tablet computer with audio, visual, audio-visual and virtual reality applications from which to choose. Time spent engaging with the iPad will be collected over four time points including prior to insertion of needle (from the time the nurse enters the room to the time the needle is inserted); during the needle insertion (whilst the needle is being inserted to the time the needle has been placed in a vein and deemed complete); after the needle is inserted (From the time the needle is placed into the vein until the dressings have been applied and the procedure is deemed complete) and total time spent engaging with the iPad. This will be collected by the researcher and will allow the assessment of intervention adherence/fidelity. Parents/guardians are permitted and encouraged to engage with the tablet computer with their child. The control group will receive ‘standard care’ from their parents and health professionals. Standard care is described as standard treatment during medical procedures including local anaesthetic cream (EMLA), parental and professional reassurance, encouragement, involvement and comforting. Stratified randomisation will be used to allocate the children to the control or intervention group by a computer generated program to ensure that equal numbers of participants of similar ages are allocated to each group.
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Intervention code [1]
299517
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Treatment: Devices
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Intervention code [2]
299551
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Prevention
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Intervention code [3]
299552
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Behaviour
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Comparator / control treatment
The control group will receive ‘standard care’ from their parents and health professionals. Standard care is described as standard treatment during medical procedures including local anaesthetic cream (EMLA), reassurance and encouragement and parental and professional staff involvement and comforting. Stratified randomisation will be used to allocate the children to the control or intervention group by a computer generated program to ensure that equal numbers of participants of similar ages are allocated to each group.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in distress levels/measures for each child. Instruments to be used to measure changes in distress levels include the Subjective Units of Distress Scale (SUDS) score.
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Assessment method [1]
303838
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Timepoint [1]
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A baseline (time point 1) Subjective Units of Distress Scale (SUDS) will be collected by the child's parents/guardian at home on either the Saturday or Sunday morning (whichever day is more relaxing for the child) prior to his or her admission for a reliable measurement of the child’s baseline. The parent will receive instructions on how to measure the child's SUDS in a pack that will be sent to the parent/guardians home ~1 week prior to the child's admission along with the salivary cortisol measurement pack and will be collected on their admission. The researcher will collect a SUDS score at the time points including prior (time point 2), during (time point 3- primary time point) and post the needle insertion (time point 4).
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Primary outcome [2]
303839
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Change in distress levels/measures for each child. Instruments to be used to measure changes in distress levels include salivary cortisol measurements.
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Assessment method [2]
303839
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Timepoint [2]
303839
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A baseline (time point 1) salivary cortisol sample measurement will be collected by the child's parent/guardian at home on either the Saturday or Sunday morning (whichever day is more relaxing for the child) prior to his or her admission for a reliable measurement of the child’s baseline. If the child is younger than school age, the sample can be collected on any day (avoiding days attending day care) whichever is most relaxing/normal for the child. Further samples will be collected during the procedure (two minutes after the needle is inserted) (time point 2) and at completion of the procedure (time point 3).
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Secondary outcome [1]
340257
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Changes in pain levels/measures for each child. Instruments to be used to measure changes in pain levels include the Face, Legs, Activity, Cry and Consolability (FLACC) Behavioural Scale.
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Assessment method [1]
340257
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Timepoint [1]
340257
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Pain scores including the FLACC will be collected pre-procedure (baseline) (time point 1), as the needle is inserted (time point 2) and immediately post procedure (time point 3). This will be calculated by the researcher.
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Secondary outcome [2]
340447
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Changes in pain levels/measures for each child. Instruments to be used to measure changes in pain levels include the Faces Pain Scale- Revised (FPS-R). This will be calculated by the researcher for children less than 4 years of age or if the child is unable/refuses to self-assess their pain scale. For children older than 4 years of age, they will be asked to describe their pain score using the FPS-R scale.
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Assessment method [2]
340447
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Timepoint [2]
340447
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The FPS=R will be recorded pre-procedure (baseline) (time point 1), as the needle is inserted (time point 2) and immediately post procedure (time point 3). This will be calculated by the researcher.
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Secondary outcome [3]
340449
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Changes in pain levels/measures for each child. Instruments to be used to measure changes in pain levels include heart rate (physiological measure). Heart rate will be collected utilising a three lead cardiac monitor.
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Assessment method [3]
340449
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Timepoint [3]
340449
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Heart rate will be measured and recorded pre-procedure (baseline) (time point 1), as the needle is inserted (time point 2) and immediately post procedure (time point 3). This will be calculated by the researcher.
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Secondary outcome [4]
340452
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Changes in procedure length time.
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Assessment method [4]
340452
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Timepoint [4]
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Instruments to be used to measure include time in minutes and seconds. This will be calculated using a stop watch and clock. Time points will include on commencement of the procedure (time point 1) to completion of the procedure (time point 2).
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Secondary outcome [5]
340453
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Time spent engaging with the computer tablet (intervention) to assess the intervention adherence/fidelity.
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Assessment method [5]
340453
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Timepoint [5]
340453
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Instruments to be used to measure include time in minutes and seconds. This will be calculated using a stop watch. Time points will include pre-procedure: from the time the nurse enters the room to the time of the needle insertion (time point 1), during needle insertion (time point 2), post needle insertion (time point 3 ) and total time spent engaging on the tablet computer throughout the procedure (time point 4 ).
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Eligibility
Key inclusion criteria
Participants will be young children aged between 18 months up 12 years of age requiring intravenous cannulation for a procedure/treatment prior scheduled.
-Developmentally appropriate to lead the distraction; and
- must have participant assent where suitable and parental/guardian consent.
- All children must have topical anaesthetic cream (EMLA) applied for 60 minutes prior to the procedure.
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Minimum age
18
Months
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Maximum age
12
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Children who require or have received sedation;
- Children who have taken steroids or ADHD medications within the last month;
- Children where response to painful stimuli maybe altered by neuromuscular disease (e.g.: Cerebral palsy);
- Children without topical anaesthetic cream;
- Non-English speaking children and/or parents/guardians; and
- Children who have been diagnosed with anxiety or ADHD.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central stratified randomisation by a computer-generated program.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
For continuous measures data will be reported using means and standard deviations, or medians and inter quartile ranges if the data is skewed. Data on an ordinal scale will be reported as medians and interquartile ranges. The mean procedural time will be compared between the two groups using an independent t test. If the data is not normally distributed a log transformation will be applied, or the non-parametric equivalent test (Mann Whitney U) will be used. For continuous outcomes measured over 3 time points (cortisol levels and physiological observations) a mixed model will be used. This model will account for the correlation between the time points, allow for missing data and provide between group comparisons at the various time points. Time will be entered as a categorical/dummy variable. Potential confounders will be considered and include previous hospitalisations, number of previous cannulations, previous negative hospital/cannulation experience, time spent engaging with the tablet computer (iPad) and age of the child. Each confounder will be considered for adjustment in the final model. Scales measured on an ordinal scale (distress and pain outcomes) will be analysed using non parametric methods, which include within group changes using Friedmans test and between group differences using the Mann Whitney U test. For the intervention group, to investigate the relationship between the level of tablet computer use and the various outcomes the number of minutes of time spent engaging with the tablet computer will be examined though scatter plots and correlation coefficients for time points 2 and 3. Alpha will be set as 0.05.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
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Other reasons
Limitations due to the move to the new Perth Children's Hospital in which significantly affected participant recruitment rates.
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Date of first participant enrolment
Anticipated
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Actual
30/10/2017
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Date of last participant enrolment
Anticipated
1/12/2020
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Actual
14/03/2018
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Date of last data collection
Anticipated
1/12/2020
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Actual
14/03/2018
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Sample size
Target
128
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Accrual to date
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Final
49
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
9317
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Princess Margaret Hospital - Subiaco
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Recruitment hospital [2]
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Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
17984
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6008 - Subiaco
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Recruitment postcode(s) [2]
23310
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
297886
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Government body
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Name [1]
297886
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WA Nursing and Midwifery Office
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Address [1]
297886
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Nursing and Midwifery Office
Department of Health
PO Box 8172
Perth Business Centre WA 6849
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Country [1]
297886
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Australia
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Primary sponsor type
Hospital
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Name
Princess Margaret Hospital for Children
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Address
Roberts Rd,
Subiaco WA 6008
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Country
Australia
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Secondary sponsor category [1]
296937
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University
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Name [1]
296937
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Curtin University
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Address [1]
296937
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Kent Street,
Bentley, WA 6102
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Country [1]
296937
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Australia
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Secondary sponsor category [2]
299482
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Hospital
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Name [2]
299482
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Perth Children's Hospital
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Address [2]
299482
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Perth Children's Hospital
15 Hospital Avenue,
Nedlands, Western Australia 6009.
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Country [2]
299482
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298934
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Curtin University Ethics
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Ethics committee address [1]
298934
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Kent Street,
Bentley, WA 6102.
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Ethics committee country [1]
298934
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Australia
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Date submitted for ethics approval [1]
298934
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01/10/2015
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Approval date [1]
298934
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28/01/2016
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Ethics approval number [1]
298934
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2015223EP
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Ethics committee name [2]
298936
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Princess Margaret Hospital HREC
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Ethics committee address [2]
298936
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Roberts Road,
Subiaco, WA 6008.
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Ethics committee country [2]
298936
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Australia
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Date submitted for ethics approval [2]
298936
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01/10/2015
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Approval date [2]
298936
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23/12/2015
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Ethics approval number [2]
298936
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2015223EP
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Summary
Brief summary
Managing pain and distress for hospitalised children undergoing medical procedures is very important as it reduces the occurrence of paediatric medical traumatic stress and other significant negative outcomes (Lindeke et al., 2006). Evidence has shown that non-pharmacological interventions such as distraction are a highly successful method in reducing distress and pain in adult and paediatric patients. At present, paediatric patients undergoing painful procedures do not routinely receive distraction therapy due to limitations such as time. With modern technology rapidly evolving, research designed to assess the effectiveness of child-led distraction using a tablet computer in reducing distress and pain in children undergoing painful medical procedures is essential. Through exploring this, a valuable contribution may promote the therapeutic practice and improve health care outcomes for children and their families. The results of this study will assist in determining whether child-led distraction through the use of a tablet computer (Apple iPad) reduces distress, pain and procedural time by incorporating a wide range of distraction methods in one convenient and cost-effective device.
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Trial website
http://campaign.curtin.edu.au/postgraduate-health/distracted-from-pain/
http://healthsciences.curtin.edu.au/schools-and-departments/nursing-midwifery-paramedicine/news/ubiquitous-ipad-may-prove-effective-pain-tool/#linkid=um-hs-pg
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Trial related presentations / publications
Nil
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Public notes
Shortened title of study is 'At their fingertips'.
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Contacts
Principal investigator
Name
78706
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Ms Jade Ferullo
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Address
78706
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Perth Children's Hospital.
Nursing Research Department.
Locked Bag 2010, Nedlands, 6909.
15 Hospital Avenue, Nedlands, Perth, Western Australia.
Curtin University.
School of Nursing, Midwifery and Paramedicine.
GPO U1987 Perth, Western Australia 6012.
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Country
78706
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Australia
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Phone
78706
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+61 08 64565195
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Fax
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Email
78706
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[email protected]
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Contact person for public queries
Name
78707
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Miss Jade Ferullo
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Address
78707
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Perth Children's Hospital.
Nursing Research Department.
Locked Bag 2010, Nedlands, 6909.
15 Hospital Avenue, Nedlands, Perth, Western Australia.
Curtin University.
School of Nursing, Midwifery and Paramedicine.
GPO U1987 Perth, Western Australia 6012.
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Country
78707
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Australia
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Phone
78707
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+61 08 64565195
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Fax
78707
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Email
78707
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[email protected]
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Contact person for scientific queries
Name
78708
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Miss Jade Ferullo
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Address
78708
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Perth Children's Hospital.
Nursing Research Department.
Locked Bag 2010, Nedlands, 6909.
15 Hospital Avenue, Nedlands, Perth, Western Australia.
Curtin University.
School of Nursing, Midwifery and Paramedicine.
GPO U1987 Perth, Western Australia 6012.
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Country
78708
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Australia
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Phone
78708
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+61 08 64565195
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Fax
78708
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Email
78708
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[email protected]
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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.
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