Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000827235
Ethics application status
Approved
Date submitted
7/05/2018
Date registered
15/05/2018
Date last updated
15/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Guided Imagery and Relaxation Technique on Psychological Functioning of Children with Cancer.
Scientific title
The Effects of Guided Imagery and Relaxation Technique on Psychological Functioning of Children with Cancer: A Randomised Controlled Trial.
Secondary ID [1] 294730 0
None
Universal Trial Number (UTN)
U1111-1213-4059
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
children with cancer 307725 0
Paediatric Cancer 307836 0
Condition category
Condition code
Cancer 306786 306786 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. This is a behavioural intervention approach called guided imagery relaxation (GIR) technique for children with cancer to improve their emotional functioning.

2. Guided imagery is based on psychoneurological theory developed by Green and Green in Vines (1988) who suggest when a person creates and holds an image in their mind, cerebral cortex and limbic system are activated. Subsequently the hypothalamus is activated to create a positive change in the autonomic nervous system. The imagination is hypothesised to induce relaxation, emotional comfort and physiological reaction, indirectly by influencing children’s cognition towards positive, calming thoughts.


3. The GIR audio has 3 versions of pre-recorded scripts; each using different imagination stimuli i.e. “The Balloon”, “The Flower Garden” and “The Flying Carpet”. The runtime for each version is “5:35 minutes, 5:36 minutes and 5:26 minutes” respectively. Except for a unique imaginary stimuli and coping strategy introduced in every version, the general structure of the scripts are made uniform. The GIR script starts with breathing technique followed by a short progressive muscle relaxation sequence. Then the listeners are guided through an imaginary journey to induce relaxation in a gradual manner. For instance, they are suggested to imagine flying up high in the sky in a big balloon, getting higher and higher and feeling more and more relaxed. Or they are guided to imagine entering in a very peaceful, beautiful, fresh and healing place such a garden and experiencing all the calming and healing sensations. Incorporated in the script are different coping strategies including distraction, magical healing pond, special support person, and the power of the Creator that promote healing, hopefulness, feeling of reliant and subsequently inner perceived strength. The script ends with deep breathing and active muscles relaxation sequences that try to bring the listeners into inner source of strength and then go back into the reality slowly in descendant order. The pre-recorded scripts are uploaded in MP3 players and children are guided to listen to the scripts using the players.

4. Children and parents in oncology ward are invited to join the study and asked to sign consent form if they agreed to participate. They are explained about the study and requested to fill in some baseline measures. A simple random sampling procedure is used to assign the consented children into two groups i.e. intervention or control group. Single-blind study is used, whereby the child is not aware if they are in the intervention group or control group, but the researcher knows. After randomization, children in the intervention group are given individual MP3 player with earphone attached and GIR audio downloaded. The children need to listen to the GIR audio at least 3 times a week for 3 weeks period. They are free to choose whichever version they wanted to repeat listening but they should listen to each version at least once. Every single week, investigator will visit or contact the children to monitor the listening task. The children in control group receives standard medical care.

5. No trained provider is needed for this self-administered intervention. In this study, a student researcher introduces the study to the children and guide them to operate the MP3 player. The listening task is done by individual child and is monitored by the student researcher every week for 3 weeks.

6. Mode of delivery – self-listening to pre-recorded GIR audio via individually-kept MP3 player, at least 3 times a week for 3 weeks.

7. Location of intervention depends on where the child is at in particular period of intervention such as in the ward or at home.

8. The children in the intervention group are required to listen to at least 3 sessions of GIR audio in a week for 3 subsequent weeks.

9. No individual tailoring is made/ needed in this intervention.

10. No modification is made for intervention in particular.

11. We tried to maintain the fidelity of the intervention by monitoring the child’s task completion in a weekly basis – asking the child’s listening activities from themselves and their parents.
Intervention code [1] 301112 0
Behaviour
Comparator / control treatment
Comparator is an active control group who receive standard medical care without any form of psychological intervention.

A standard medical treatment for peadiatric cancer mainly involves (selection of ) respective internationally recognised chemotherapy protocol administered onto individual child depends on their specific cancer diagnosis (and other relevant conditions) for example, AML 12 protocol for Acute Myeloid Leukemia and UKALL protocol for Acute Lymphoblastic Leukemia.

Control group
Active

Outcomes
Primary outcome [1] 305773 0
The Pediatric Quality of Life Inventory (PedsQL) - Parent-reported
Timepoint [1] 305773 0
Baseline - before intervention
Post-intervention - within 48 hours of completing the 3-week intervention
Primary outcome [2] 305774 0
PedsQL Present Functioning Visual Analogue Scale (PedsQL VAS) -Parent proxy- Report
Timepoint [2] 305774 0
Basline - pre-assessment
Post-assessment - within 48 hours of completing the 3-week intervention
Secondary outcome [1] 346503 0
PedsQL Present Functioning Visual Analogue Scale (PedsQL VAS) -Child- Report
Timepoint [1] 346503 0
Baseline - pre assessment
Post-assessment - within 48 hours of completing the 3-week intervention

Eligibility
Key inclusion criteria
a) The child is treated for any type of cancer in the selected hospital;

b) The child is between 6 to 17 years old;

c) The child reaches minimal cognitive ability required i.e. the child is able to understand instructions;

d) The child speaks and understands Bahasa Melayu adequately;

e) The child and parents are consented;

f) The child commits to complete the entire audio hearing sessions.
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) The child is very sick during the study as verified by oncologists;

b) The child and parent is not consented

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)
Concealed allocation is made by central randomisation via computer software 'Research Randomizer'.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We applied simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).

The children were placed into either intervention or control group using computer generated table of random numbers obtained via random collection software available online which is “Research Randomizer” with the portal address was (https://www.randomizer.org/) (Kim and Shin 2017).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For PedsQL VAS and PedsQL Generic scales we use Repeated Measure ANOVA to allow for measurement of the same variables made on each subject on two or more different occasions. The data from Repeated Measure ANOVA analysis are interpreted in terms of Within-subject design (time effect) and Between -group (intervention effect).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
2/11/2015
Date of last participant enrolment
Anticipated
Actual
5/09/2016
Date of last data collection
Anticipated
Actual
31/10/2016
Sample size
Target
78
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 10380 0
Malaysia
State/province [1] 10380 0
Kelantan

Funding & Sponsors
Funding source category [1] 299338 0
University
Name [1] 299338 0
Short Term Grant Universiti Sains Malaysia
Country [1] 299338 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia
Address
Universiti Sains Malaysia
11800 USM
Penang
MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 298606 0
Charities/Societies/Foundations
Name [1] 298606 0
National Cancer Council Malaysia
Address [1] 298606 0
National Cancer Council Malaysia
Majlis Kanser Negara (MAKNA)
BG 03A and 05
Ground Floor Megan Ambassy
No 225 Jalan Ampang
50450 Kuala Lumpur
MALAYSIA
Country [1] 298606 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300245 0
Human Research Ethics Committee USM (HREC)
Ethics committee address [1] 300245 0
Ethics committee country [1] 300245 0
Malaysia
Date submitted for ethics approval [1] 300245 0
06/04/2015
Approval date [1] 300245 0
27/10/2015
Ethics approval number [1] 300245 0
USM/JEPeM/15040130

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2668 2668 0 0
/AnzctrAttachments/374993-ETHIC PDF.pdf (Ethics approval)
Attachments [2] 2669 2669 0 0
/AnzctrAttachments/374993-OJMP_2013070515121218.pdf (Publication)
Attachments [3] 2670 2670 0 0
/AnzctrAttachments/374993-consent form.pdf (Participant information/consent)

Contacts
Principal investigator
Name 83030 0
A/Prof Azizah Othman
Address 83030 0
Department of Paediatrics, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country 83030 0
Malaysia
Phone 83030 0
+60 9 767 6525
Fax 83030 0
Email 83030 0
[email protected]
Contact person for public queries
Name 83031 0
Azizah Othman
Address 83031 0
Department of Paediatrics, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country 83031 0
Malaysia
Phone 83031 0
+60 9 767 6525
Fax 83031 0
Email 83031 0
[email protected]
Contact person for scientific queries
Name 83032 0
Azizah Othman
Address 83032 0
Department of Paediatrics, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country 83032 0
Malaysia
Phone 83032 0
+60 9 767 6525
Fax 83032 0
Email 83032 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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