Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000071527
Ethics application status
Approved
Date submitted
1/12/2023
Date registered
29/01/2024
Date last updated
23/02/2024
Date data sharing statement initially provided
29/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Day-to-Day events on Pain Management Program Outcomes: A Feasibility Study.
Scientific title
Impact of Day-to-Day events on Pain Management Program Outcomes: A Feasibility study
Secondary ID [1] 311076 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 332220 0
Placebo effect 332343 0
Nocebo effect 332344 0
Condition category
Condition code
Anaesthesiology 328937 328937 0 0
Pain management
Mental Health 329054 329054 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure

CALM is run for 3.5 hours every Friday for 5 weeks. We aim to run 10 groups in a calendar year. Each group has a few focus points e.g. managing thoughts, mindfulness, placing activity, ergonomics, exercise, sleep hygiene, diet, pain flare management etc.
CALM group program is part of our standard care. The patients will be attending the CALM group program regardless of whether they are in the study or not.
-All patient attending the weekly CALM group program run by Central Coast Integrated Pain Service (CCIPS) during the study period, will fill out a seven-question daily questionnaire for the 28 days between their first and last session. Each question has predetermined answers to select from as well as comments section for any thoughts they wish to express.
-If the patient reports that something made their pain better, it will be recorded as a positive daily experience or placebo response.
-If the patient reports that something made their pain worse it will be recorded as a negative daily experience or a nocebo response and if the patient was able to do something to make their pain better again, it will be recorded as nocebo correction.
-Every patient fills out a national benchmarking ePPOC (electronic Persistent Pain Outcomes Collaboration) Questionnaire upon referral to a pain unit. If this was filled out more than 6 months prior to them commencing CALM, it is routine to ask for another benchmarking ePPOC questionnaire to be completed prior to commencement of CALM and this will be applicable to the study patients as well.
-On the last day of the CALM group the patients fill out another ePPOC questionnaire which again is part of standard care.
-Individual averages of placebo, nocebo and nocebo correction will be averaged out and compared with the change if any in their pre and post CALM ePPOC scores.
-As per standard care, if at any time the patients are triggered by any aspect of CALM program or in the study by any aspect of daily questionnaire, they will be provided appropriate support in the form of urgent phone call by directly involved CCIPS staff (if not by PI), urgent individual appointment with pain specialist, referral to any other service as applicable and/or immediate removal form the study.
Intervention code [1] 327613 0
Not applicable
Comparator / control treatment
It is a cohort study. There is no separate control group. The aim is to capture the within group differences in relation to the expectations based on their daily experience as captured using daily questionnaires.
Based on the responses to the daily questionnaires the impact of their daily events will be classified as placebo, nocebo and nocebo correction in keeping with predetermined rules mentioned din the study protocol. This will be analysed against any improvement or worsening of their pain psychometrics before and after the CALM group program.
Control group
Active

Outcomes
Primary outcome [1] 336856 0
placebo scores
Timepoint [1] 336856 0
During the 28 days of CALM group Program
Primary outcome [2] 336857 0
nocebo scores
Timepoint [2] 336857 0
During the 28 days of CALM group program
Primary outcome [3] 337152 0
Nocebo correction scores
Timepoint [3] 337152 0
During the 28 days of CALM group program
Secondary outcome [1] 429514 0
Proportion of patients with placebo, nocebo and nocebo control
Timepoint [1] 429514 0
Cumulative data collected over 28 days of CALM group program
Secondary outcome [2] 429895 0
Patients getting triggered and distressed.
Timepoint [2] 429895 0
During the 28 days of CALM group program
Secondary outcome [3] 430873 0
Response to this distress
Timepoint [3] 430873 0
Throughout the 28 days of CALM group program and for 2 weeks after that

Eligibility
Key inclusion criteria
• All patients aged 18 years and above presenting for CALM group program run by Central Coast Integrated Pain Service over the study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Refusal to consent
2. Poor literacy
3. Learning or behavioural issues
4. Other sensory barrier-visual, auditory etc
5. No or limited access to internet, poor phone connection eg remote regions.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/02/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25900 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 41735 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 315425 0
Hospital
Name [1] 315425 0
Gosford Hospital
Country [1] 315425 0
Australia
Primary sponsor type
Individual
Name
Dr Vidya Shirumalla
Address
Gosford Hospital, 75 Holden street, Gosford, NSW 2250
Country
Australia
Secondary sponsor category [1] 317492 0
None
Name [1] 317492 0
Address [1] 317492 0
Country [1] 317492 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314256 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 314256 0
Level 11, KGV Building Missenden Road, CAMPERDOWN NSW 2050
Ethics committee country [1] 314256 0
Australia
Date submitted for ethics approval [1] 314256 0
04/12/2023
Approval date [1] 314256 0
14/02/2024
Ethics approval number [1] 314256 0

Summary
Brief summary
This study aims to assess the effect of positive and negative expectations that develop in response to our daily experience. It is believed that positive expectations increase the benefit from pain program and negative expectations reduce the benefit from the same pain program. Study participants will be asked to fill out a daily questionnaire containing the same seven questions for 28 days when they attend the weekly CALM group program. This will then be assessed against changes in their pain psychometrics before and after the pain program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130950 0
Dr Vidya Shirumalla
Address 130950 0
Gosford Hospital, 75 Holden street, Gosford, NSW 2250
Country 130950 0
Australia
Phone 130950 0
+61450955595
Fax 130950 0
Email 130950 0
Vidya.Shirumalla@health.nsw.gov.au
Contact person for public queries
Name 130951 0
Dr Vidya Shirumalla
Address 130951 0
Gosford Hospital, 75 Holden Street, Gosford, NSW 22250
Country 130951 0
Australia
Phone 130951 0
+61 02 4320 5423
Fax 130951 0
Email 130951 0
Vidya.Shirumalla@health.nsw.gov.au
Contact person for scientific queries
Name 130952 0
Dr Vidya Shirumalla
Address 130952 0
Gosford Hospital, 75 Holden Street, Gosford NSW 2250
Country 130952 0
Australia
Phone 130952 0
+61 02 4320 5423
Fax 130952 0
Email 130952 0
Vidya.Shirumalla@health.nsw.gov.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?

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
No additional documents have been identified.