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Trial registered on ANZCTR


Registration number
ACTRN12620000988954
Ethics application status
Approved
Date submitted
31/07/2020
Date registered
30/09/2020
Date last updated
30/09/2020
Date data sharing statement initially provided
30/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Hypnotherapy for Pain, Itch and Anxiety in Burned Children: A feasibility and effectiveness study
Scientific title
Hypnotherapy for Pain, Itch and Anxiety in Burned Children: A feasibility and effectiveness study
Secondary ID [1] 301926 0
Nil known
Universal Trial Number (UTN)
U1111-1256-3014
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute burns

 318440 0
Procedural pain 318441 0
State anxiety 318442 0
Burn-related itch 318443 0
Condition category
Condition code
Anaesthesiology 316446 316446 0 0
Pain management
Alternative and Complementary Medicine 316447 316447 0 0
Other alternative and complementary medicine
Mental Health 317197 317197 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Face-to-face hypnotherapy interventions will be delivered individually for children with acute burns during their visits to the burns centre at the hospital for dressing changes. The provider of the interventions is a certified hypnotherapist with more than 8 years of experience in conducting hypnotherapy with children from diverse backgrounds with a range of conditions involving pain and distress in therapeutic and medical settings. During the first visit, the intervention will involve a pre-hypnosis interview provided before medication intake, hypnotic suggestibility test (i.e., standard induction of hypnosis and test suggestions) starting right before the dressing change; followed by therapeutic suggestions for pain and anxiety before emergence from hypnosis. The intervention during the first visit will last up for 45 minutes and involves a pre-hypnosis interview for up to 10 minutes, a hypnotic suggestibility test for 20 minutes and suggestions for up to 15 minutes. In the following visits, hypnotherapy interventions will consist of hypnotherapy sessions provided as described in the intervention manual that was specifically developed for procedural pain, state anxiety and itch in children with burns and that can be obtained upon request. A hypnotherapy session involves induction and deepening of hypnosis followed by therapeutic suggestions before emerging from hypnosis. Hypnotherapy sessions will start right before removing the dressing change and end when the new dressing is applied and thus will have the same duration as dressing changes, which is between 20 and 35 minutes. A maximum of five interventions will be provided for children on their weekly hospital visits for dressing changes over five weeks until their burns heal. Following the delivery of the initial intervention, children will be provided with a taped recording of instructions for self-hypnosis to reduce the time needed to teach them self-hypnosis. Children will be asked to practice self-hypnosis for 20 minutes daily during their participation in the study for up to five weeks. The hypnotherapist will adhere to the manual in delivering core elements of the intervention as assessed by a fidelity completion of intervention checklist to facilitate replication and target procedural pain, state anxiety and itch. The intervention will be tailored and adapted as informed by the pre-hypnosis interview and suggestibility screening to account for the hypnotherapist’s style as well as influencing factors of hypnotic responsiveness and pain (e.g., child-related factors, contextual factors related to the acute hospital setting involving parents and clinicians). Pre-recorded music will accompany all hypnotherapy sessions. Hypnotherapy will be provided as an adjunct to pain medications that will be administered orally 20 minutes before the dressing changes in specific dosages, as determined by body weight: oxycodone 0.1 mg/kg, Paracetamol 150 mg/kg, Ibuprofen 10mg/kg. Active (e.g., interactive toys including video games, virtual reality devices, controlled breathing, guided imagery) and passive distraction techniques (e.g., passive music, videos on a portable device) will also be used as part of standard pre or post-procedural care.
Intervention code [1] 318205 0
Treatment: Other
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324600 0
Previous data show that with hypnosis, no serious adverse reactions (ARs) have been reported and other ARs such as anxiety reactions, dizziness and unpleasant thoughts have been very rare. The safety and tolerability of the intervention will be assessed by rate, timing, duration and severity of adverse events using reports and semi-structured interviews as well as by drop-out rates.
Timepoint [1] 324600 0
Families’ and clinicians’ adverse events and drop-out rates will be assessed by their reports and semi-structured interview after each dressing change following the collection of data on pain and anxiety outcomes for a maximum of 5 changes.
Primary outcome [2] 324941 0
Implementation of the intervention and study procedures will be assessed by fidelity measures referring to the degree of completeness of collected data on health outcomes (amount and type of missing data), the level of adherence to the study-specific intervention checklist and retention rate.
Timepoint [2] 324941 0
Fidelity measures and retention rates will be conducted following dressing changes and collection of data up for a maximum of 5 dressing changes.
Primary outcome [3] 324942 0
Acceptability of study procedures will be assessed by feedback regarding the intervention (likes, dislikes, recommendations, reported perceived benefits, required time and effort) assessed using semi-structured interviews and field notes (hypnotherapist session notes) and satisfaction with the intervention and health outcomes measurements (clinicians will only rate their satisfaction with the hypnotherapy session) on 11-point Numeric Rating Scales.
Timepoint [3] 324942 0
Families’ and clinicians’ satisfaction ratings and feedback on the intervention (likes, dislikes, recommendations, reported perceived benefits, required time and effort) will be assessed after each dressing change for a maximum of 5 changes.
Secondary outcome [1] 385149 0
Heart rate, a physiologic measure of pain and distress will be measured using a monitoring device.
Timepoint [1] 385149 0
Heart rate will be measured during, right before and right after dressing changes for a maximum of 5 dressing changes.
Secondary outcome [2] 385150 0
Acute procedural pain intensity will be assessed by children's self-report using Faces Pain Scale-Revised (children under 8 yrs) or 11-point Numeric Rating Scale for Pain Intensity (children aged 8 yrs or above) and nurses' behavioural measure of pain using FLACC scale;
Timepoint [2] 385150 0
Children's acute procedural pain intensity will be assessed before, after and during dressing changes for a maximum of 5 dressing changes
Secondary outcome [3] 385156 0
Itch intensity will be assessed using 11-point NRS.
Timepoint [3] 385156 0
Itch intensity will be assessed after dressing changes starting from the third visit until the fifth visit for a maximum of 3 dressing changes
Secondary outcome [4] 385157 0
Degree of children's involuntariness in responding to hypnotic suggestions will be measured using Bower's 0-5 numeric scale.

Timepoint [4] 385157 0
Involuntariness in responding to hypnotic suggestions will be retrospectively measured after the dressing change during the first visit only
Secondary outcome [5] 386267 0
State anxiety will be assessed using a 100mm Visual Analog Scale.
Timepoint [5] 386267 0
State anxiety will be assessed before, after and during dressing changes for a maximum of 5 dressing changes
Secondary outcome [6] 386269 0
The duration of dressing changes until 95% re-epithelialisation will be assessed by clinicians.
Timepoint [6] 386269 0
Data on the duration of dressing changes until 95% re-epithelialisation will be obtained from medical records or reports of clinicians after dressing changes for a maximum of 5 dressing changes.
Secondary outcome [7] 386272 0
Salivary alpha-amylase levels, a physiologic measure of pain and distress will be measured using ELISA kits (Stratech Scientific, Avalon NSW).
Timepoint [7] 386272 0
Saliva samples will be collected at least 20 minutes before medication intake and 10 minutes following dressing changes for a maximum of 5 dressing changes. Samples will be stored at 4°C to be spun in a centrifuge at 1400 × g for 10 minutes at room temperature and then frozen at - 80°C until analysis in triplicate within 7 days.
Secondary outcome [8] 386386 0
Barriers and facilitators to the acceptability of the intervention and study procedures related to parents and children will be assessed by their willingness to participate ( rate of families willing to participate out of those approached for participation) and beliefs/views on hypnotherapy assessed using semi-structured interviews.
Timepoint [8] 386386 0
The rate of families willing to participate, parents’ and children’s beliefs/views on hypnotherapy will be assessed before the first dressing change.
Secondary outcome [9] 386387 0
Barriers and facilitators to implementation of the intervention and study procedures will be assessed by the adequacy of resources, presence/absence of interruption, time availability for study procedures assessed using field notes (e.g. hypnotherapist session notes) and intervention pre-recordings.
Timepoint [9] 386387 0
Barriers and facilitators to implementation will be assessed before, after and during dressing changes for a maximum of 5 dressing changes.
Secondary outcome [10] 386454 0
Acute procedural pain unpleasantness will be assessed using 11-point Numeric Rating Scale (children aged 8 yrs or above).
Timepoint [10] 386454 0
Children's acute procedural pain unpleasantness will be assessed before, after and during dressing changes for a maximum of 5 dressing changes
Secondary outcome [11] 386455 0
Itch frequency will be assessed by questions on the number of itch episodes per week and per day.
Timepoint [11] 386455 0
Itch frequency will be assessed after dressing changes starting from the third visit until the fifth dressing change for a maximum of 3 dressing changes
Secondary outcome [12] 386456 0
Data on the % of re-epithelialisation will be obtained from medical records or reports of clinicians.
Timepoint [12] 386456 0
Data on the % of re-epithelialisation will be obtained after dressing changes for a maximum of 5 dressing changes.
Secondary outcome [13] 386457 0
Data on the total number of dressing changes until 95% re-epithelialisation will be obtained from medical records or reports of clinicians.
Timepoint [13] 386457 0
Data on the total number of dressing changes until 95% re-epithelialisation will be obtained after dressing changes for a maximum of 5 dressing changes.
Secondary outcome [14] 387370 0
Barriers and facilitators to the acceptability of the intervention and study procedures related to clinicians (clinicians adoption) will be assessed by the rate of clinicians consenting to participate among those conducting dressing changes.
Timepoint [14] 387370 0
The rate of clinicians consenting to participate will be assessed before the first dressing change.
Secondary outcome [15] 387371 0
Children’s level of perceived self-efficacy on 11-point Likert scale
Timepoint [15] 387371 0
Children’s level of perceived self-efficacy will be assessed before their first dressing change
Secondary outcome [16] 387372 0
children’s level of positive therapy expectations on 11-point Likert scale.
Timepoint [16] 387372 0
children’s level of positive therapy expectation will be assessed before their first dressing change.

Eligibility
Key inclusion criteria
Children will be included if they have an acute burn injury of any depth (except superficial burns or erythema), are aged 4 to 16 years, and speak English.
Parents of eligible children will also be included if they speak English. Clinicians will be included if they conduct child participants’ dressing changes during the study period.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will be excluded if they are deaf, cognitively impaired, on ventilator support, require general anaesthesia for their first dressing change, have involvement with child safety or disability services, or have a large total body surface burn (TBSA >10%). Non-English speaking parents will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data collection, analysis and synthesis will be conducted using a mixed-methods design integrating multiple data sources (clinicians, parents, children) as well as quantitative and qualitative data. Qualitative and quantitative data will be collected concurrently then analysed independently before integration. Descriptive statistics (frequencies, percentages, medians and interquartile ranks) will be used to present quantitative data on children’s sociodemographic and clinical characteristics as well as on health and feasibility outcomes and factors. Data analysis will be conducted using Excel and SPSS 26 (IBM Corporation, Armonk, NY, USA). Semi-structured interviews will be audio-recorded, transcribed verbatim and analysed using framework analysis for qualitative analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2020
Actual
Date of last participant enrolment
Anticipated
5/11/2020
Actual
Date of last data collection
Anticipated
5/04/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17179 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 30879 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 306339 0
University
Name [1] 306339 0
The University of Queensland, Faculty of Medicine
Country [1] 306339 0
Australia
Primary sponsor type
University
Name
The University of Queensland, Faculty of medicine
Address
Oral Health Centre Reception, Level 6, Oral Health Centre (883), 288 Herston Road
Herston, QLD 4006.
Country
Australia
Secondary sponsor category [1] 306841 0
Individual
Name [1] 306841 0
Professor Roy Kimble
Address [1] 306841 0
Queensland Children's Hospital, 501 Stanley Street, South Brisbane, QLD 4101.
Country [1] 306841 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306548 0
Queensland Children’s Hospital (QCH) and Health Services Human Research Ethical Committee
Ethics committee address [1] 306548 0
Ethics committee country [1] 306548 0
Australia
Date submitted for ethics approval [1] 306548 0
27/08/2019
Approval date [1] 306548 0
04/09/2019
Ethics approval number [1] 306548 0
HREC/19/QCHQ/53945

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

Contacts
Principal investigator
Name 104250 0
Dr Daly Geagea
Address 104250 0
Centre for Children’s Health Research, Level 7, 62 Graham Street, South Brisbane, 4101 QLD.
Country 104250 0
Australia
Phone 104250 0
+61730697428
Fax 104250 0
Email 104250 0
d.geagea@uq.net.au
Contact person for public queries
Name 104251 0
Daly Geagea
Address 104251 0
Centre for Children’s Health Research, Level 7, 62 Graham Street, South Brisbane, 4101 QLD.
Country 104251 0
Australia
Phone 104251 0
+61730697428
Fax 104251 0
Email 104251 0
d.geagea@uq.net.au
Contact person for scientific queries
Name 104252 0
Daly Geagea
Address 104252 0
Centre for Children’s Health Research, Level 7, 62 Graham Street, South Brisbane, 4101 QLD.
Country 104252 0
Australia
Phone 104252 0
+61730697428
Fax 104252 0
Email 104252 0
d.geagea@uq.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8651Ethical approval    380298-(Uploaded-30-07-2020-16-29-56)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHypnotherapy for procedural pain, itch, and state anxiety in children with acute burns: a feasibility and acceptability study protocol.2022https://dx.doi.org/10.1186/s40814-022-01017-z
N.B. These documents automatically identified may not have been verified by the study sponsor.