Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000735651
Ethics application status
Approved
Date submitted
14/06/2023
Date registered
6/07/2023
Date last updated
6/07/2023
Date data sharing statement initially provided
6/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of a Challenge State Intervention on Patient Recovery when Undergoing Elective Orthopaedic Surgery
Scientific title
The Effects of a Challenge State Intervention on Patient Recovery when Undergoing Elective Orthopaedic Surgery
Secondary ID [1] 309888 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recovery from surgery 330350 0
Osteoarthritis 330351 0
Degenerative lumbar spine disease 330352 0
Condition category
Condition code
Surgery 327194 327194 0 0
Other surgery
Musculoskeletal 327195 327195 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are patients who will be undergoing elective hip and knee replacements and lumbar decompression.
The intervention is a motivational script developed based on previous Challenge and Threat state studies. It will be delivered by a trained member of the study team via phone to the participant undergoing surgery. The intervention will be delivered once two days prior to the scheduled date of operation. The participants will be expected to receive the phone call in their own home.
Participants from the same group will receive the same scripted intervention, i.e. those in the intervention group will receive the Intervention Script and those in the control group will receive the Control script (a scripted phone call without the intervention).
The initial script for both phone calls are the same: participants will be asked questions about their feelings towards the operation and post-operative recovery and then informed that they will meet a member of the research team and answer some questionnaires on the day of surgery. The script for the control group terminates here.
For the intervention group, the script continues and the intervention is delivered. Topics covered includes:
- supports available during hospital stay and post-discharge
- what participants can expect post-operatively
The phone calls are anticipated to last 5-10 minutes depending on which script the patient receives.
The intervention will be delivered by a member of the research team; phone logs will be audited to monitor the delivery of the intervention.
Intervention code [1] 326314 0
Treatment: Other
Intervention code [2] 326315 0
Behaviour
Comparator / control treatment
The control group/comparator for this study will be patients undergoing elective hip and knee replacements and lumbar decompression who have not received the intervention. Both groups will be receiving the the standard care; however the only difference is the intervention group will receive the intervention prior to their planned procedure date. The standard care involves: routine pre-, intra- and post-anaesthetic and surgical cares, then routine cares on the ward. Routine care on the wards involves multidisciplinary team approach (physiotherapist, occupational therapist, nursing etc.) for rehabilitation and discharge planning.
Control group
Active

Outcomes
Primary outcome [1] 335073 0
Length of stay in hospital collected by review of medical records
Timepoint [1] 335073 0
At time of hospital discharge
Secondary outcome [1] 422925 0
Pain score using visual analogue scale collected by questionnaire
Timepoint [1] 422925 0
baseline and at 2 and 6 weeks after surgery
Secondary outcome [2] 422926 0
For participants who received a total hip joint replacement, functional score will be assessed using Hip disability and Osteoarthritis Outcome Score (HOOS) questionnaire
Timepoint [2] 422926 0
Baseline and at 2 and 6 weeks post surgery
Secondary outcome [3] 422927 0
Quality of life assessed using EuroQol-5D score (EQ-5D) questionnaire
Timepoint [3] 422927 0
Baseline and at 2 and 6 weeks post surgery
Secondary outcome [4] 423443 0
For participants who received a total knee joint replacement, functional score will be assessed using Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Timepoint [4] 423443 0
Baseline and at 2 and 6 weeks post surgery
Secondary outcome [5] 423444 0
For participants undergoing lumbar decompression, functional score will be assessed using Oswestry Disability Index (ODI) questionnaire
Timepoint [5] 423444 0
Baseline and at 2 and 6 weeks post surgery

Eligibility
Key inclusion criteria
o Aged 18 or older and able to give informed consent
o Elective surgery
o Surgeries: lumbar decompression, knee joint replacement, hip joint replacement
o Public patients and private outsource patients
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
o Revision surgery
o Previous major surgery (requiring general, spinal or epidural anaesthetic)
o Less than 18 years of age
o Hard of hearing/unable to converse on phone

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients who have consented to participate in the study will be randomised into the intervention group or the control group using block randomisation with block sizes of eight.
The block randomisation will be computer generated using a randomisation software. Patients and the surgeon will be blinded to the allocation.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 25590 0
New Zealand
State/province [1] 25590 0
Waikato region

Funding & Sponsors
Funding source category [1] 314072 0
Charities/Societies/Foundations
Name [1] 314072 0
Waikato Medical Research Foundation
Country [1] 314072 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato Hospital
Address
183 Pembroke Street
Waikato Hospital
Hamilton
3204
Country
New Zealand
Secondary sponsor category [1] 315981 0
None
Name [1] 315981 0
Address [1] 315981 0
Country [1] 315981 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313212 0
Cental Health and Disability Ethics Comittee
Ethics committee address [1] 313212 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 313212 0
New Zealand
Date submitted for ethics approval [1] 313212 0
08/05/2023
Approval date [1] 313212 0
31/05/2023
Ethics approval number [1] 313212 0
2023 EXP 16717

Summary
Brief summary
The aim of this study is to examine the effects of a “challenge state intervention” on the ability of elective orthopaedic patients to cope with recovering from surgery and on their perceptions of the surgery itself by delivering a pre-operative verbal intervention via phone. We will be examining whether there is a relationship between short-term (at 2 and 6 weeks) post-operative outcomes and satisfaction in participants compared to those who have not received a challenge state intervention.

The research has its basis in the Biopsychosocial Model of Challenge and Threat which is a theory in psychology that provides insight into individual responses to stressful situations. The theory hypothesises that individuals who perceive a situation as a challenge (i.e., in which they believe they have sufficient resources to cope with the situation) have a more adaptive approach than those who perceive the situation as a threat. Previous evidence suggests that those who appraise a situation as a challenge have more positive performance outcomes in various contexts including sports. In recent years, the focus has shifted to examining the effect of challenge and threat states in patients undergoing surgery and we hope to extent what we know with this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127358 0
Dr Cindy Ou
Address 127358 0
183 Pembroke Street
Waikato Hospital
Hamilton
3204
Country 127358 0
New Zealand
Phone 127358 0
+64 78398899
Fax 127358 0
Email 127358 0
xinyi.ou@waikatodhb.health.nz
Contact person for public queries
Name 127359 0
Dr Cindy Ou
Address 127359 0
183 Pembroke Street
Waikato Hospital
Hamilton
3204
Country 127359 0
New Zealand
Phone 127359 0
+64 78398899
Fax 127359 0
Email 127359 0
xinyi.ou@waikatodhb.health.nz
Contact person for scientific queries
Name 127360 0
Dr Cindy Ou
Address 127360 0
183 Pembroke Street
Waikato Hospital
Hamilton
3204
Country 127360 0
New Zealand
Phone 127360 0
+64 78398899
Fax 127360 0
Email 127360 0
xinyi.ou@waikatodhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be shared for this trial. Only the members of the research team will have access to identifiable data.


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.