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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.
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.
Secondary ID [1] 293256 0
None
Universal Trial Number (UTN)
U1111-1204-5677
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distress 305306 0
Pain 305307 0
Anxiety 305308 0
Condition category
Condition code
Mental Health 304610 304610 0 0
Anxiety
Anaesthesiology 304659 304659 0 0
Pain management

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 299517 0
Treatment: Devices
Intervention code [2] 299551 0
Prevention
Intervention code [3] 299552 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 303838 0
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.
Timepoint [1] 303838 0
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).
Primary outcome [2] 303839 0
Change in distress levels/measures for each child. Instruments to be used to measure changes in distress levels include salivary cortisol measurements.
Timepoint [2] 303839 0
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).
Secondary outcome [1] 340257 0
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.
Timepoint [1] 340257 0
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.
Secondary outcome [2] 340447 0
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.
Timepoint [2] 340447 0
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.
Secondary outcome [3] 340449 0
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.
Timepoint [3] 340449 0
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.
Secondary outcome [4] 340452 0
Changes in procedure length time.
Timepoint [4] 340452 0
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).
Secondary outcome [5] 340453 0
Time spent engaging with the computer tablet (intervention) to assess the intervention adherence/fidelity.
Timepoint [5] 340453 0
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 ).

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.
Minimum age
18 Months
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Central stratified randomisation by a computer-generated program.
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Limitations due to the move to the new Perth Children's Hospital in which significantly affected participant recruitment rates.
Date of first participant enrolment
Anticipated
Actual
30/10/2017
Date of last participant enrolment
Anticipated
1/12/2020
Actual
14/03/2018
Date of last data collection
Anticipated
1/12/2020
Actual
14/03/2018
Sample size
Target
128
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9317 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [2] 11405 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 17984 0
6008 - Subiaco
Recruitment postcode(s) [2] 23310 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 297886 0
Government body
Name [1] 297886 0
WA Nursing and Midwifery Office
Country [1] 297886 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital for Children
Address
Roberts Rd,
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 296937 0
University
Name [1] 296937 0
Curtin University
Address [1] 296937 0
Kent Street,
Bentley, WA 6102
Country [1] 296937 0
Australia
Secondary sponsor category [2] 299482 0
Hospital
Name [2] 299482 0
Perth Children's Hospital
Address [2] 299482 0
Perth Children's Hospital
15 Hospital Avenue,
Nedlands, Western Australia 6009.
Country [2] 299482 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298934 0
Curtin University Ethics
Ethics committee address [1] 298934 0
Ethics committee country [1] 298934 0
Australia
Date submitted for ethics approval [1] 298934 0
01/10/2015
Approval date [1] 298934 0
28/01/2016
Ethics approval number [1] 298934 0
2015223EP
Ethics committee name [2] 298936 0
Princess Margaret Hospital HREC
Ethics committee address [2] 298936 0
Ethics committee country [2] 298936 0
Australia
Date submitted for ethics approval [2] 298936 0
01/10/2015
Approval date [2] 298936 0
23/12/2015
Ethics approval number [2] 298936 0
2015223EP

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78706 0
Ms Jade Ferullo
Address 78706 0
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.
Country 78706 0
Australia
Phone 78706 0
+61 08 64565195
Fax 78706 0
Email 78706 0
[email protected]
Contact person for public queries
Name 78707 0
Jade Ferullo
Address 78707 0
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.
Country 78707 0
Australia
Phone 78707 0
+61 08 64565195
Fax 78707 0
Email 78707 0
[email protected]
Contact person for scientific queries
Name 78708 0
Jade Ferullo
Address 78708 0
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.
Country 78708 0
Australia
Phone 78708 0
+61 08 64565195
Fax 78708 0
Email 78708 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

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