Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000687291
Ethics application status
Approved
Date submitted
19/04/2018
Date registered
27/04/2018
Date last updated
9/02/2022
Date data sharing statement initially provided
9/02/2022
Date results provided
9/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Re-frame the pain: Using attention and language to reduce needle pain and distress in children
Scientific title
Reframe the pain: Using attention and language to manage needle pain and distress in children
Secondary ID [1] 294139 0
APS/APRA/CFK#2
Universal Trial Number (UTN)
U1111-1210-1302
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fear of needles 306847 0
Needle pain 306848 0
Condition category
Condition code
Public Health 305943 305943 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All children that participate in the study will receive a single 0.5 mL intramuscular injection to the upper arm of Fluarix Tetra Inactivated influenza Vaccine. This vaccine will include the following strains as recommended by the World Health Organisation (WHO) for inclusion in the 2018 Southern Hemisphere vaccine: A/Michigan/45/2015 (H1N1) pdm09-like virus; A/Singapore/INFIMH-16-0019/2016(H3N2)-like virus; B/Phuket/3037/2013-like virus; B/Brisbane/60/2008-like virus.
The injection will be provided via a one-on-one intervention by a paediatric nurse experienced in administering flu vaccinations. When possible, a parent or guardian of the participating child will be present during the vaccination. The injections will primarily be provided at the University of South Australia, City East Campus, but may also be provided at schools in South Australia (if sufficient interest within a school). The two clinical nurses involved in this trial will each receive ~4 hours of training, including written information on the intervention procedures for each group, guided practice of each of the intervention, and assessment of intervention fidelity using pilot participants. Training and assessment of intervention fidelity prior to trial commencement will be completed by CIs Stanton and Noel.

Participants will be randomised to one of 4 intervention groups: 1. Positive memory reframing; 2. Divided attention; 3. Positive memory reframing plus divided attention; 4. Usual standard care. All interventions will be videotaped during the trial to allow for assessment of intervention fidelity and to allow for specific coding of the strategies used in each intervention, most relevant to categorise the strategies used in ‘usual care’.

Group 1. Positive memory reframing:
For many children getting a needle can be a painful, distressing experience. This fear can have significant consequences, leading to vaccine hesitancy. Pain influences children long after the painful stimulus is removed.1 Children’s memories of needle-related pain are a powerful predictor of future pain experiences, and are more influential to future pain than the initial experience of pain itself.2-4 Memory is susceptible to distortion. Negative biases in pain memories (recalling higher levels of pain as compared to initial pain report) are associated with higher subsequent pain, distress, and worse medical compliance.2,5 Children’s pain memory development is influenced by multiple factors,1,6 including the child’s anxiety,7 pain-related fear,8 sex,9 and age.10 Children’s memories for pain are malleable through post-event information,11 yet very few studies have examined memory reframing interventions in the context of children’s recall of (needle) pain.12 Positive memory reframing involves talking to children for a few minutes to emphasise the positive aspects of a past painful experience, correct exaggerations in recall, and foster a sense of self-efficacy in their pain coping.13

Participants randomised to this group will receive an individualised intervention that aims to focus on positive aspects of their pain needle experience to promote a feeling of self-efficacy in their coping abilities. To individualise the intervention, the clinical nurse will first speak with the parent or guardian about the child’s previous needle experience with the aim of determining 1-2 positive things that occurred during the past experience. The nurse will then engage with the child and have the child recall positive features of their past needle experience, even if minimal (e.g., a friendly nurse), that will be supplemented by parent input (if available). Any exaggerations of recall will be addressed (e.g., the previous needle procedure actually only took 2 minutes not 10 minutes) and will be supported by parent input (if available). The nurse will also praise specific strategies that the child used well (e.g., deep breaths) and will affirm that the child is brave, together promoting increased self-efficacy for pain coping. Following this, the needle will be provided. A similar process will occur after the injection, with the clinical nurse praising how well the child handled the experience, pointing out specific strategies that they used that were excellent, affirming their bravery, and including a positive statement for the future (e.g., “You did so well, the next time you get a needle you will do excellent”). This intervention will take ~6 minutes to provide (time differences may occur depending on the time it takes for parents/children to provide information about the previous vaccine experience).

Group 2. Divided attention.
Another way to reduce the negative impact of pain and fear related to needle procedures is to decrease the intensity of the painful experience itself. It is well established that attention and expectation are important contributors to the experience of pain.14-16 For example, distraction (i.e., removal of attention) during a needle procedure has been shown to reduce pain.17 Recent work has shown that the effects of attention and expectation are more spatially precise than previously realised.18 In other words, even small shifts in attention can reduce pain. For example, when attention/expectation are divided between two locations on the arm (you expect to receive a painful stimulus in one of two locations), it has been shown that a stimulus provided between those two locations feels less painful than when attention/expectation are not divided.17 Because needles and their resultant pain are spatially precise (e.g., you feel it in one small area of skin), this paradigm may be useful to reduce the pain intensity felt from a needle merely by taking advantage of the way our nervous system works.

Prior to receiving the vaccine injection, participants in this group will play a game that results in them dividing their attention between two areas on their upper arm. The nurse will identify two spots on the child’s upper shoulder, one above and one below the location where the vaccination will be given. Using either the rubber end of a pencil or their index finger, the nurse will touch the child’s skin in spot one or spot two (random order, slightly varying exact location each time) and will ask the child to identify which spot was touched. If this is too easy (i.e., child getting all correct), then the nurse will increase the speed of touching and if still too easy, will then provide the touch in triplets or quadruplets, with the child needing to identify the pattern of touch (e.g., spot 1, spot 2, then spot 2). Prior to the needle, participants will be told that because touching the skin in the two spots like this makes the two spots go a bit numb, the needle will be provided in one of the two spots and their very important job is to figure out which spot the needle was given to. Consistent with past study findings (and in order to take advantage of the pain-relieving properties of divided attention), the nurse will provide the needle in between the two spots. The child will be asked at the end to identify to which spot the needle was given. This intervention will take ~4 minutes to provide.

Group 3. Positive memory reframing and divided attention.
This group will receive both strategies to test whether there is a super-additive effect on pain and fear when high levels of self-efficacy for pain coping are promoted and when attention is divided to decrease the pain of the needle itself. This group will receive the positive memory reframing first, followed by the divided attention game. Identical procedures will be used such that following the needle, participants will receive positive memory reframing strategies (as delivered in group 1) and will be asked about where they thought the needle was given (as performed in group 2). This group will take 7-8 minutes to provide the intervention.

References:
1. Noel M, Chambers CT, Petter M, McGrath PJ, Klein RM, Stewart SH. Pain Manag. 2012;2:487.
2. von Baeyer CL, Marche TA, Rocha EM, Salmon K. J Pain. 2004;5:241.
3. Noel M, Chambers CT, McGrath PJ, Klein RM, Stewart SH. Pain. 2012;153:1563.
4. Noel M, Pavlova M, McCallum L, Vinall J. Can Psychol. 2017;58:58.
5. Arntz A, van Eck M, Heijmans M. Behav Res Ther. 1990;28:29.
6. Noel M, Palermo TM, Chambers CT, Taddio A, Hermann C. Pain. 2015;156:31.
7. Noel M, Chambers CT, McGrath PJ, Klein RM, Stewart SH. J Pediatr Psychol. 2012;37:567.
8. Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Pediatrics. 2006;118:651.
9. Hechler T, Chalkiadis GA, Hasan C, Kosfelder J, Meyerhoff U, Vocks S, Zernikow B. J Pain. 2009;10:586.
10. Noel M, Rabbitts JA, Tai GG, Palermo TM. Pain. 2015;156:800.
11. Noel M. J Pediatr Psychol. 2016;41:232.
12. Bruck M, Ceci SJ, Francoeur E, Barr R. Child Development 1995;66:193-208.
13. Noel M, McMurtry CM, Pavlova M, Taddio A. Pain Pract. 2017. DOI: 10.1111/papr.12572.
14. Miron D, Duncan GH, Bushnell MC. Pain 1989;39:345-52.
15. Quevedo AS, Coghill RC. J Neurosci 2007;27:11635–11640.
16. Johnston NE, Atlas LY, Wager TD. PloS ONE 7:e38854.
17. Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD005179.
18. Stanton TR, Gilpin H, Reid E, Spence C, Mancini F, Moseley GL. J Pain 2016; 20:753-66.
Intervention code [1] 300495 0
Treatment: Other
Intervention code [2] 300504 0
Treatment: Drugs
Comparator / control treatment
Group 4: Usual standard care
This group will receive usual best practice standard of care procedures as normally employed by the clinical nurses. This typically includes having the nurse engage with the participant (e.g., calming them down if anxious) and using a method of verbal distraction when providing the needle. Analysis of the videotaped interventions using a standardised coding scheme will be performed to characterise what exact procedures were used by clinical nurses for each participant.
Control group
Active

Outcomes
Primary outcome [1] 304985 0
To assess the feasibility of successfully conducting a large RCT that investigates the effect of divided attention, positive memory reframing, divided attention plus positive memory reframing versus usual care - through the evaluation of pre-specified feasibility criteria.

The specific feasibility criteria will include: 1) recruitment rate (% of eligible participants recruited/week); 2) retention (loss to follow-up at 2 weeks); 3) intervention fidelity (% of interventions provided in full content).

This is a composite primary outcome measure.
Timepoint [1] 304985 0
At trial completion.
Primary outcome [2] 304986 0
To assess the composition of intervention interactions with the aim to improve intervention content and delivery to maximise benefit in future studies.

The content of intervention interactions will be evaluated in terms of the coping and distress promoting behaviours exhibited by the treating nurse, the participant (child), and the parent, using the short-form Child-Adult Medical Procedure Interaction Scale (CAMPIS-SF) to score these behaviours from the video-recorded intervention.
Timepoint [2] 304986 0
During intervention delivery (via videotape)
Primary outcome [3] 304987 0
To assess treating nurses’ perspectives on the clinical interventions with the aim to improve intervention content and delivery to maximise benefit in future studies.

Treating clinicians will be interviewed and their experiences with the interventions explored (including perceived strengths, weaknesses, and suggestions for improvement) with qualitative content data analysis undertaken.
Timepoint [3] 304987 0
At trial completion.
Secondary outcome [1] 343811 0
Needle pain-related fear expectancy, i.e., expected fear for future vaccinations .

This will be assessed using the Children's Fear Scale (CFS). To assess fear expectancy, the following wording will be used: Now I want you to think about the next time you have to get a needle again and what that would be like. Have a look at these faces and tell me the letter under the face that shows how scared you think you will be the next time you get a needle.
Timepoint [1] 343811 0
Baseline and two weeks post-vaccination (via telephone interview)
Secondary outcome [2] 343846 0
Needle pain intensity expectancy; i.e., expected pain intensity for future vaccinations

This will be assessed using the Faces Pain Scale-Revised (FPSR). The following wording will be used: Now I want you to think about the next time you have to get a needle again and what that would be like. Have a look at the scale and tell me the letter under the face that shows how much pain you think you will have the next time you get a needle.
Timepoint [2] 343846 0
Baseline and two weeks post-vaccination (via telephone interview)
Secondary outcome [3] 343847 0
Parent recall of child's pain intensity during the vaccination

This will be measured using a numerical rating scale:
How much pain do you think your child felt during the needle?
On a scale from 0 (no pain) to 10 (most pain).
Timepoint [3] 343847 0
At two weeks post-vaccination (via telephone interview)
Secondary outcome [4] 345800 0
Parent recall of child pain-related fear during the vaccination

This will be measured using a numerical rating scale:
How scared was your child during the needle?
On a scale from 0 (not at all scared) to 10 (most scared).
Timepoint [4] 345800 0
Two weeks post-vaccination (via telephone interview)
Secondary outcome [5] 345801 0
Parent self-efficacy

This will be measured using a numerical rating scale:
Based on all the things you have done to deal with your child's pain, how confident are you that you could decrease your child's pain if you tried?
On a scale from 0 (not at all confident) to 10 (most confident)
Timepoint [5] 345801 0
Two weeks post-vaccination (via telephone interview)
Secondary outcome [6] 345844 0
Immediate needle pain intensity (**Note: this outcome is a primary outcome measure)

This will be assessed using the Faces Pain Scale-Revised (FPSR). To assess immediate pain, the following wording will be used:
How much pain did you feel during the needle? Have a look at the scale and tell me the letter under the face that shows how much pain you had during the needle.
Timepoint [6] 345844 0
Immediately after vaccination
Secondary outcome [7] 406069 0
Recall of needle pain intensity. This will be evaluated using a reliable and validated scale for this population: the Faces Pain Scale-Revised (FPSR). To assess the participants' recall of the pain intensity experienced during the vaccination, the following wording will be used: Think back to when you had your vaccination and remember what you felt. Have a look at the scale and tell me the letter under the face that shows how much pain you had during the needle. Reference: Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001;93(2):173-183.
Timepoint [7] 406069 0
Two weeks post vaccination via telephone interview. Participants will be provided with copies of the face scale to take home so that they can use this to answer the telephone interview questions. If they have lost the copy, they will be provided with the scale via an online Surveymonkey link.
Secondary outcome [8] 406070 0
Recall of needle pain-related fear. This will be evaluated using a reliable and validated scale for this population: the Children's Fear Scale (CFS). To assess the participants' recall of the pain-related fear experienced during the vaccination, the following wording will be used: Think back to when you had your vaccination and remember what you felt. Have a look at these faces and tell me the letter under the face that shows how scared you were when you got your needle. Reference: McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011;30(6):780-788.
Timepoint [8] 406070 0
Two weeks post vaccination via telephone interview. Participants will be provided with copies of the face scale to take home so that they can use this to answer the telephone interview questions. If they have lost the copy, they will be provided with the scale via an online Surveymonkey link.
Secondary outcome [9] 406071 0
Immediate needle pain-related fear This will be assessed using the Children's Fear Scale (CFS). To assess immediate pain-related fear, the following wording will be used: How scared were you during the needle? Have a look at these faces and tell me the letter under the face that shows how scared you were during the needle.
Timepoint [9] 406071 0
Immediately after vaccination
Secondary outcome [10] 406072 0
Adverse events (participant distress during needle application, any relevant side effects/adverse effects from the vaccination or the needle experience).

Participant distress during the needle procedure was assessed via researcher review of the video-recording of the trial intervention and coded using the short-form Child-Adult Medical Procedure Interaction Scale (CAMPIS-SF). Side effects/adverse effects from the vaccination or the needle experience were assessed via open ended questions at the 2 week follow-up telephone interview of children and their parents.
Timepoint [10] 406072 0
During intervention provision, immediately after needle, 2 week follow-up.
Secondary outcome [11] 406073 0
Nurse rapport with child assessed using an 11-point numerical rating scale (0 = extremely poor quality rapport, 10 = extremely high quality rapport); assessed via external rater using the video-recorded session
Timepoint [11] 406073 0
During intervention

Eligibility
Key inclusion criteria
We will recruit 256 children, aged between 8-12 years who are living in South Australia and who have consented to receive a yearly flu vaccination.

Both the child and their parent/guardian will provide written informed consent.
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with a history of severe allergic reaction (e.g., anaphylaxis) after a vaccine, severe egg allergies (e.g., respiratory distress/required epinephrine), with a diagnosed anxiety disorder/post traumatic stress disorder, or moderate-severe illness (with or without fever) on the day will be excluded.

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)
Allocation will be concealed by using sequentially numbered, sealed, opaque envelopes created by an investigator not involved in the study. An independent researcher (Dr Stanton) will provide the envelope to the treating nurse, such that the project manager (who assesses study outcomes), remains blinded to group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule will be created using computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
All treatment sessions will be videotaped. This will allow us to determine intervention fidelity and will guide the per protocol analysis.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Feasibility outcomes
Feasibility of study procedures and intervention fidelity will be examined in terms of frequencies and percentages. Descriptive statistics (means, SDs, frequencies, and ranges) will be used to summarize other intervention factors, including the rapport scores for the nurses, the CAMPIS-SF scores, and the coding of verbal and non-verbal content during the memory interview phone calls with children and parents at two weeks. Descriptive syntheses will be used to summarize the communication patterns of the nurses during interventions, and the content of the phone interviews with the nurses to assess their perceptions of the interventions.

Preliminary clinical outcomes
Given the feasibility nature of this study, we will conduct exploratory analyses on child and parent clinical outcomes (i.e., child and parent ratings of child needle-related pain intensity and fear; child catastrophizing; and parent anxiety and confidence) using available data. Missing data will be excluded from the analyses. Overall (all four groups combined) and within-group changes over time in recall of pain intensity, pain-related fear (primary) and all secondary outcomes will be analyzed using repeated measures ANOVAs and paired t-tests, respectively. Sensitivity analyses excluding participants who had adverse events will be completed. Within-group change scores and their 95% confidence intervals will also be calculated.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
19/04/2018
Date of last participant enrolment
Anticipated
31/05/2019
Actual
24/07/2019
Date of last data collection
Anticipated
21/06/2019
Actual
7/08/2019
Sample size
Target
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 22184 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 298775 0
Charities/Societies/Foundations
Name [1] 298775 0
Australian Pain Society- Clinical Research Grant
Country [1] 298775 0
Australia
Funding source category [2] 299327 0
Charities/Societies/Foundations
Name [2] 299327 0
Australian Pain Relief Association - Clinical Research Grant
Country [2] 299327 0
Australia
Funding source category [3] 299328 0
Charities/Societies/Foundations
Name [3] 299328 0
Cops for Kids - Clinical Research Grant
Country [3] 299328 0
Australia
Primary sponsor type
Individual
Name
Dr Tasha Stanton
Address
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 297959 0
Individual
Name [1] 297959 0
Dr Melanie Noel
Address [1] 297959 0
Department of Psychology
The University of Calgary
2500 University Dr. N.W.
Calgary, AB, T2N 1N4
Canada
Country [1] 297959 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299722 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 299722 0
Ethics committee country [1] 299722 0
Australia
Date submitted for ethics approval [1] 299722 0
27/02/2018
Approval date [1] 299722 0
09/03/2018
Ethics approval number [1] 299722 0
Application ID: 200775
Ethics committee name [2] 300010 0
Department for Education and Child Development
Ethics committee address [2] 300010 0
Ethics committee country [2] 300010 0
Australia
Date submitted for ethics approval [2] 300010 0
07/02/2018
Approval date [2] 300010 0
19/02/2018
Ethics approval number [2] 300010 0
2018-0010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2561 2561 0 0
/AnzctrAttachments/374578-Participant information sheet_Needle project_FINAL_27.03.2018_highlights removed.docx (Participant information/consent)
Attachments [2] 2562 2562 0 0
/AnzctrAttachments/374578-PARTICIPANT CONSENT FORM_FINAL.docx (Participant information/consent)
Attachments [3] 2563 2563 0 0
/AnzctrAttachments/374578-UniSA ethics approval.pdf (Ethics approval)
Attachments [4] 2564 2564 0 0
/AnzctrAttachments/374578-DECD approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 81370 0
A/Prof Tasha Stanton
Address 81370 0
University of South Australia, IIMPACT in Health, GPO Box 2471, Adelaide SA 5001
Country 81370 0
Australia
Phone 81370 0
+61 8 8302 2090
Fax 81370 0
Email 81370 0
[email protected]
Contact person for public queries
Name 81371 0
Tasha Stanton
Address 81371 0
University of South Australia, IIMPACT in Health, GPO Box 2471, Adelaide SA 5001
Country 81371 0
Australia
Phone 81371 0
+61 8 8302 2090
Fax 81371 0
Email 81371 0
[email protected]
Contact person for scientific queries
Name 81372 0
Tasha Stanton
Address 81372 0
University of South Australia, IIMPACT in Health, GPO Box 2471, Adelaide SA 5001
Country 81372 0
Australia
Phone 81372 0
+61 8 8302 2090
Fax 81372 0
Email 81372 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Treatment group-specific child and parent outcomes for all initial primary and secondary outcomes measures relating to the needle experience.
When will data be available (start and end dates)?
Upon publication (anticipated Feb 2022) and ending 5 years following publication
Available to whom?
Researchers who provide a methodologically sound proposal; this decision will be made on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Meta-analysis or IPD meta-regression.
How or where can data be obtained?
Via email to the primary sponsor ([email protected]).


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
SourceTitleYear of PublicationDOI
EmbaseReframe the pain: Divided attention and positive memory reframing to reduce needle pain and distress in children-A feasibility randomized controlled trial.2022https://dx.doi.org/10.1002/ejp.1992
N.B. These documents automatically identified may not have been verified by the study sponsor.