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Trial registered on ANZCTR


Registration number
ACTRN12615000419561
Ethics application status
Approved
Date submitted
13/04/2015
Date registered
1/05/2015
Date last updated
28/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial Investigating Medical Hypnosis for Faster Healing & Pain Reduction in Children Following Burn Injury
Scientific title
A Randomised Controlled Trial Investigating Medical Hypnosis for Faster Reepithelialisation & Pain Reduction in Children Following Burn Injury
Secondary ID [1] 286525 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Burns 294744 0
Condition category
Condition code
Injuries and Accidents 295028 295028 0 0
Burns
Alternative and Complementary Medicine 295108 295108 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Burns and associated wound care procedures are painful and distressing for children. In addition to being painful, burn injuries can also result in severe psychological distress. Previous research has indicated that a reciprocal relationship may exist between symptoms of psychological distress and burn pain. Thus, treatment options that alleviate distress in both symptom areas must be offered to patients in order to optimize care. However, this proves difficult in clinical practice because many patients indicate that dressing changes and mechanical debridement (i.e. cleaning/removal of dead tissue) of burn wounds are in fact more painful than the original burn insult, provoking intense anticipatory anxiety.
To prepare patients for burn wound care procedures a variety of pharmacological analgesia protocols are employed. Non-pharmacological techniques such as medical hypnosis are used as an adjunct to pharmacological methods for control of pain and anxiety. Importantly, a reduction in pain during burn wound care procedures has a demonstrated improvement in rate of re-­epithelialisation, an essential component of wound-healing. Medical hypnosis helps patients focus their awareness and attention to lessen pain and anxiety and encourage faster wound-healing. The technique has been demonstrated to decrease pain and anxiety in the short-­term and decrease psychological distress over the long-term, thereby optimizing patient outcomes and complementing existing treatment modalities.
A hypnotherapist is a healthcare worker trained to use medical hypnosis, a technique used to naturally guide patients into a trance state which allows them to process information, including pain sensation, differently from how it is processed in the regular alert state. The patient is guided into trance by listening to the words of the hypnotherapist and following their instructions; patients can also be taught self-hypnosis which allows them to enter trance by themselves. As a therapeutic tool, medical hypnosis can help patients decrease their pain and anxiety levels by becoming more comfortable and relaxed, in addition to other significant psychological, physiological, and behavioral benefits.
In our study, patients in the experimental group will receive hypnotherapy in addition to standard care (i.e. standard analgesia and wound care procedures). A maximum of 5 hypnotherapy sessions will take place, depending on the time it takes the burn wound to heal (i.e. >95% re-­epithelialisation). During each session, the patient will be guided into trance using hypnosis at the start of their burn wound care procedure (either their first application of dressings OR a subsequent dressing change, depending on their initial presentation to our Burns Unit). Each hypnotherapy session will last for the entire duration of the wound care procedure and will end after the new dressings are in place.



Intervention code [1] 291615 0
Treatment: Other
Comparator / control treatment
Standard Care. Standard care is equivalent to using standard analgesia and wound care protocols as currently established and maintained by the Lady Cilento Children's Hospital, Brisbane.
Control group
Active

Outcomes
Primary outcome [1] 294787 0
Time to Re­-epithelialisation: The number of days from the time of the burn until >95% re-­epithelialisation will be measured by treating consultant and blinded review of photographs.
Timepoint [1] 294787 0
Time when burn is >95% re-­epithelialised.
Primary outcome [2] 294790 0
Pain: The Faces Pain Scale - Revised (FPS­R) will be used to measure the child’s self­-report of pain. Additionally, nurses will record a behavioral/observational rating on the Face, Legs, Arms, Cry, Consolability (FLACC) scale. Parents will also be asked to rate their child’s pain using a numerical rating scale (NRS).
Timepoint [2] 294790 0
Timepoint 1: Prior to premedication, before first application of burns dressings OR before first dressings change (i.e. prior to removal/application of dressings).

Timepoint 2: After application of burns dressings.
Secondary outcome [1] 314044 0
Heart rate (HR) will be recorded as a physiological measure of pain and distress. HR will be assessed by palpating the radial pulse at the wrist or via pulse oximeter.
Timepoint [1] 314044 0
Timepoint 1: Prior to premedication, before first application of burns dressings OR before first dressings change (i.e. prior to removal/application of dressings).

Timepoint 2: After application of burns dressings.
Secondary outcome [2] 314045 0
Anxiety: Visual Analog Scale for Anxiety (VAS-A). The patient will complete this scale if they are age 8 or older. Otherwise the parent will be asked to assess their child's anxiety level.
Timepoint [2] 314045 0
Timepoint 1: Prior to premedication, before first application of burns dressings OR before first dressings change (i.e. prior to removal/application of dressings).

Timepoint 2: After application of burns dressings.
Secondary outcome [3] 314046 0
PTSD Severity: Child PTSD Symptom Scale (CPSS). The patient (i.e. child) will complete this scale.
Timepoint [3] 314046 0
3 months post-injury.
Secondary outcome [4] 314047 0
Caregiver "Level of Satisfaction" with Burns Dressing Change:
At the conclusion of every dressing change caregivers (i.e. parent/guardian) will rate their level of satisfaction with that particular wound care procedure on a five point Likert scale.
Timepoint [4] 314047 0
After application of burns dressings.
Secondary outcome [5] 314048 0
Salivary cortisol and salivary alpha-amylase (biological markers of stress).
Timepoint [5] 314048 0
Timepoint 1: Prior to premedication, before first application of burns dressings OR before first dressings change (i.e. prior to removal/application of dressings).

Timepoint 2: Immediately after application of burns dressings.

Timepoint 3: At 3-month follow-up to establish true baseline.
Secondary outcome [6] 314049 0
Stanford Hypnotic Clinical Scale for Children (SHCSC)
Timepoint [6] 314049 0
Timepoint: Upon patient's second presentation to the Burns Clinic (for study dressing change #2), prior to removal of dressings.

To avoid interfering with a patient’s initial presentation to clinic but to obtain a rigorous, vetted measure of hypnotizability for experimental subjects, the Stanford Hypnotic Clinical Scale for Children will be used to assess and objectively record the child's hypnotizability. This Gold-standard assessment will be conducted within the Intervention Group only to ensure that control subjects remain naive to hypnosis/hypnotherapy.

Eligibility
Key inclusion criteria
Eligible participants will be children aged 4-16 years who meet the inclusion criteria of: (1) an acute burn of any depth (excluding erythema only), and (2) presentation to the Pegg­ Leditschke Children's Burns Centre, Lady Cilento Children's Hospital, Brisbane, AUS.
Minimum age
4 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Age >16 years old, (b) non-English speaking, (c) cognitive impairment, (d) Child Safety involvement, (e) on ventilator support, (f) has dressings/dressing changes carried out in operating theatre under general anaesthesia, or (g) documented history of epilepsy, seizures, or psychiatric illness.

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)
Treating physicians/nursing staff of all children meeting the inclusion/exclusion criteria presenting to the LCCH, Brisbane will determine eligibility for enrolment in the study. With the parent's/caregiver's permission an investigator aligned with the study will discuss the study with the parents/caregivers and seek informed consent. (When appropriate, assent from the child will also be obtained.) Once informed consent is obtained participants will be randomised to one of two groups, control or intervention. Randomisation will be undertaken by the use of sealed, opaque, identical and serially numbered envelopes prepared by an independent party.
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary outcome measures are days to re-epithelialisation and pain. Previous data in paediatric burns patients demonstrated re-epithelialisation within 15 (SD = 4) days and a minimally clinically-important difference is 3 days. Thus sample size was calculated at 28 per group at 80% power with an alpha value of 0.05. Allowing for 10% loss to follow up, a total of 62 participants will be required. The LCCH treats 800 children per year with burns, thus recruitment for this study should be achievable. This sample size will also be adequate to find a significant difference in data collected from pain scores. Data will be entered into SPSS (SPSS, Chicago, 22.0). Demographics such as age, gender and mechanism of injury will be described and data presented as mean and standard deviation or median and interquartile range as appropriate. All data will be analysed as intention to treat and on a per protocol basis, with the intention to treat analysis being the primary approach for this trial. Differences between groups will be assessed using Students t-test or Mann-Whitney U test where appropriate. Total body surface area (TBSA), age and gender are considered a-priori to be potential confounding variables and will be incorporated into regression models when determining factors affecting re-epithelialisation. Statistical significance will be set at p < 0.05.

Recruitment
Recruitment status
Active, not 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)
QLD
Recruitment hospital [1] 3692 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 9517 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 291086 0
Other Collaborative groups
Name [1] 291086 0
Centre for Children's Burns & Trauma Research, Queensland Children's Medical Research Institute
Address [1] 291086 0
Centre for Children's Burns & Trauma Research, Level 7, Centre for Children's Health Research, 62 Graham St., South Brisbane, QLD 4101, Australia
Country [1] 291086 0
Australia
Primary sponsor type
Individual
Name
Stephen Jack Chester
Address
Centre for Children's Burns & Trauma Research
Level 7, Centre for Children's Health Research
62 Graham St.
South Brisbane, QLD 4101
Australia
Country
Australia
Secondary sponsor category [1] 289766 0
Individual
Name [1] 289766 0
Professor Roy M. Kimble, MD-Qld, MBChB, FRCS, FRACS
Address [1] 289766 0
7D Surgical Directorate, Level 7
Lady Cilento Children’s Hospital
501 Stanley St.
South Brisbane, QLD 4101
Country [1] 289766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292668 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 292668 0
Level 3, RCH Foundation Building
Royal Children’s Hospital
Herston Road
Herston QLD 4029

Ethics committee country [1] 292668 0
Australia
Date submitted for ethics approval [1] 292668 0
Approval date [1] 292668 0
25/03/2015
Ethics approval number [1] 292668 0
HREC/15/QRCH/32
Ethics committee name [2] 292669 0
The University of Queensland Institutional Human Research Ethics Committe
Ethics committee address [2] 292669 0
The University of Queensland
Cumbrae-Stewart Building
Research Road
Brisbane QLD 4072
Ethics committee country [2] 292669 0
Australia
Date submitted for ethics approval [2] 292669 0
Approval date [2] 292669 0
27/03/2015
Ethics approval number [2] 292669 0
2015000456

Summary
Brief summary
It is well­-documented that burns and the associated wound care procedures are painful and distressing for children. Non-­pharmacological techniques are used in addition to pharmacological methods for control of pain and anxiety. Medical hypnosis in adults undergoing burn wound debridement (wound-cleaning and removal of dead tissue) has resulted in reductions in pain and anxiety. To our knowledge, there have not been any randomised controlled trials that have examined the efficacy of medical hypnosis to decrease healing times and pain/anxiety scores in paediatric burn patients.
The aim of this study is to investigate whether medical hypnosis reduces pain and anxiety and enhances re­-epithelialisation (i.e. wound-healing) in children with acute burn injury. We hypothesise that there will be significantly lower pain and anxiety scores, lower levels of biological stress markers (cortisol and alpha-­amylase) and faster wound re-epithelialisation in the intervention group compared with the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56494 0
Mr Stephen Jack Chester
Address 56494 0
Centre for Children's Burns & Trauma Research
Level 7, Centre for Children's Health Research
62 Graham St.
South Brisbane, QLD 4101
Australia
Country 56494 0
Australia
Phone 56494 0
+61 7 36361278
Fax 56494 0
+61 7 3636 5578
Email 56494 0
sjackchester@gmail.com
Contact person for public queries
Name 56495 0
Mr Stephen Jack Chester
Address 56495 0
Centre for Children's Burns & Trauma Research
Level 7, Centre for Children's Health Research
62 Graham St.
South Brisbane, QLD 4101
Australia
Country 56495 0
Australia
Phone 56495 0
+61 7 36361278
Fax 56495 0
+61 7 3636 5578
Email 56495 0
sjackchester@gmail.com
Contact person for scientific queries
Name 56496 0
Mr Stephen Jack Chester
Address 56496 0
Centre for Children's Burns & Trauma Research
Level 7, Centre for Children's Health Research
62 Graham St.
South Brisbane, QLD 4101
Australia
Country 56496 0
Australia
Phone 56496 0
+61 7 36361278
Fax 56496 0
+61 7 3636 5578
Email 56496 0
sjackchester@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary