Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001156875
Ethics application status
Approved
Date submitted
26/10/2012
Date registered
31/10/2012
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of pre-operative education on patients' pain and anxiety following joint replacement: A feasibility study
Scientific title
In patients booked for joint replacement, is a pre-operative self-efficacy education on pain and anxiety management more effective than no education in reducing post-operative pain and anxiety?
Secondary ID [1] 281443 0
Nil
Universal Trial Number (UTN)
U1111-1136-3796
Trial acronym
The POEt feasibility study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain post joint replacement surgery 287703 0
Anxiety post joint replacement surgery 287704 0
Condition category
Condition code
Musculoskeletal 288041 288041 0 0
Other muscular and skeletal disorders
Surgery 288052 288052 0 0
Other surgery
Mental Health 288053 288053 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will use a single-blinded, repeated measures, parallel, RCT testing feasibility outcomes. Participants will be randomly assigned to either the self-efficacy education intervention [A] or routine care [B] group. Sequential sampling of all eligible patients from two surgical (orthopaedics) units will take place at The Queen Elizabeth II Jubilee (QEII) and Robina hospitals, both located in South East Queensland. The intervention involves pre-operative self-efficacy based education sessions of around 20 – 30 minutes delivered via a DVD. Based on the work of Marks and Allegrante (2005), the self-efficacy activities identified in the DVD include goal-setting and relaxation exercises (such as mindfulness and deep breathing exercises, listening to music and guided imagry), for participants to practice prior to and following surgery. Participants in the intervention group will receive the DVD at the booked pre-operative session at both research sites to take home with them. They will be asked to review this DVD within 72 hours and then on three other occasions prior to their admission for surgery. A research assistant (registered nurse) will call the participants at 72 hours and then again before admission to support participation. Participants in both groups will receive routine in-hospital pre- and post-operative care provided by both the Queensland Health hospitals. Post-operatively this will include all care provided by healthcare professionals in terms of nursing, wound care, physiotherapy and pain management.
Intervention code [1] 285949 0
Treatment: Other
Intervention code [2] 285962 0
Prevention
Intervention code [3] 285963 0
Behaviour
Comparator / control treatment
Participants in both groups will receive routine in-hospital pre- and post-operative care provided by both the Queensland Health hospitals. Post-operatively this will include all care provided by healthcare professionals in terms of nursing, wound care, physiotherapy and pain management.
Control group
Active

Outcomes
Primary outcome [1] 288249 0
Evaluate the feasibility of launching a full-scale multi-site efficacy trial, using pre-defined feasibility criteria for recruitment, retention, protocol fidelity.

For purposes of this feasibility study, researchers will recruit 100 participants (50 per treatment group). This will provide adequate information to answer the study aims. Current admissions data regarding the number of hip/knee replacements undertaken at the 2 hospital sites this year suggests that there is likely to be a total of 48 potentially eligible patients each month. We expect to recruit around 20 participants per month, thus suggesting a sample of 100 will be realistically achieved in about five months.
Timepoint [1] 288249 0
Sample achieved (50 per group) within research time period (5 months).
Primary outcome [2] 288250 0
Use pilot data to refine the protocol. Data will be collected using the following tools: 1. The Numeric Rating Scale for pain; 2. The State Trait Anxiety Inventory, Form Y for anxiety; 3. The General Self-efficacy Scale for self-efficacy; 4. The Total Quality Pain Management survey for patient satisfaction with nursing care; 5. The Use and Frequency of Pain Medication (via the participant and end-of-bed medication sheets); 6. The Health Service and Resource Utilisation Survey I; 7. The Health Service and Resource Utilisation Survey II; 8. The Relaxation Method Utilisation Survey
Timepoint [2] 288250 0
Sample achieved (50 per group) within research time period (5 months)
Secondary outcome [1] 299729 0
Assess whether pre-operative self-efficacy based education intervention holds promise on pain in patients undergoing hip or knee replacement using the Numeric Rating Scale (NRS)
Timepoint [1] 299729 0
Assessment for the NRS will occur at 5 time-points: two to six week pre-operative (T0); day of surgery (T1); two days after surgery (T2); 10-14 days after discharge from hospital (T4), and 6 weeks after discharge (T5). The first data collection time-point (T0) will be at the routine pre-operative hospital appointment and before they are randomised into treatment groups. Once baseline data is collected treatment group allocation will be determined by telephoning an automated service at the university's independent CTCC. T1 and T2 data will in most cases, be collected whilst the participant is in hospital. If the patient is scheduled for surgery early in the morning for T1, they may be called at home the day before. T4 will be collected 10 -14 days post discharge via telephone and T5 will be collected via telephone 6 weeks following discharge from hospital.
Secondary outcome [2] 299766 0
Assess whether pre-operative self-efficacy based education intervention holds promise on anxiety in patients undergoing hip or knee replacement using the State Trait Anxiety Inventory [STAI], Form Y.
Timepoint [2] 299766 0
Assessment for the STAI will occur at 5 time-points: two to six week pre-operative (T0); day of surgery (T1); two days after surgery (T2); 10-14 days after discharge from hospital (T4), and 6 weeks after discharge (T5). The first data collection time-point (T0) will be at the routine pre-operative hospital appointment and before they are randomised into treatment groups. Once baseline data is collected treatment group allocation will be determined by telephoning an automated service at the university's independent CTCC. T1 and T2 data will in most cases, be collected whilst the participant is in hospital. If the patient is scheduled for surgery early in the morning for T1, they may be called at home the day before. T4 will be collected 10 -14 days post discharge via telephone and T5 will be collected via telephone 6 weeks following discharge from hospital.
Secondary outcome [3] 299767 0
Assess whether pre-operative self-efficacy based education intervention holds promise on self-efficacy in patients undergoing hip or knee replacement using the General Self-efficacy Scale - GSS.
Timepoint [3] 299767 0
Assessment for the GSS will occur at 4 time-points: two to six week pre-operative (T0); day of surgery (T1); two days after surgery (T2); and 10-14 days after discharge from hospital (T4). The first data collection time-point (T0) will be at the routine pre-operative hospital appointment and before they are randomised into treatment groups. Once baseline data is collected treatment group allocation will be determined by telephoning an automated service at the university's independent CTCC. T1 and T2 data will in most cases, be collected whilst the participant is in hospital. If the patient is scheduled for surgery early in the morning for T1, they may be called at home the day before. T4 will be collected 10 -14 days post discharge via telephone.
Secondary outcome [4] 299768 0
Assess whether pre-operative self-efficacy based education intervention holds promise on satisfaction with pain management in patients undergoing hip or knee replacement using the Total Quality Pain Management [TQPM] survey.
Timepoint [4] 299768 0
The TQPM will be assessed at data assessment point 'T3', the morning of discharge/day 4 post-operatively,(whichever comes first).
Secondary outcome [5] 301217 0
Assess whether pre-operative self-efficacy based education intervention holds promise on the use and frequency of pain medication.
Timepoint [5] 301217 0
The use and frequency of pain medication will be measures at 5 time points (T0, T2-5), via direct patient report or end-of bed medication sheets.
Secondary outcome [6] 301218 0
Assess whether pre-operative self-efficacy based education intervention holds promise on the utilisation of health services an resources.
Timepoint [6] 301218 0
Patients will be asked to identify their utilsation of heath services and resources at 2 points following their discharge from hospital: T4 (10-14 days after discharge) via telephone at a suitable time and; T5 (6 weeks after discharge) via telephone at a suitable time.
Secondary outcome [7] 301219 0
Assess whether pre-operative self-efficacy based education intervention holds promise on the utilisation of relaxation methods.
Timepoint [7] 301219 0
Patients will be asked to complete the Relaxation Method Utilisation survey via telephone at a suitable time, 6 weeks after discharge from hospital (T5).

Eligibility
Key inclusion criteria
> 18 years, medically assessed at QEII/Robina, booked admission for hip/knee replacement, informed consent, able to watch a DVD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cannot read or write English, cognitive or mental impairment which prevents them from completing self-report surveys

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A Research Nurse (ResN) will formally screen patients for eligibility face-to-face during the booked usual pre-operative education sessions organized and delivered by staff at both research sites. Participants will be provided with an information package giving clear details of the research. Each information package will include a Consent Form that participants will sign if agreeing to participant in the study. The package will also include a Revocation of Consent Form, which participants can complete should they wish to withdraw from the research any time throughout its conduct.
ResN will obtain a code depicting the group to which each participant will be randomly allocated by telephoning an independent automated service at Griffith University's Clinical Trials Coordinating Centre. Computer-generated random assignment will occur at the point of study entry, and each patient will be allocated to a numbered trial group. All members of the research team involved in participant recruitment, randomisation and data collection will be blinded to group allocation, as will nurses providing routine post-operative hospital care ensuring concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will involve a 1:1 ratio with random variations in block sizes, stratified by hospital site. This will be achieved by the ResN who will obtain a code depicting the group to which each participant will be randomly allocated, by telephoning an independent automated service at Griffith University's Clinical Trials Coordinating Centre.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Repeated measures
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2013
Actual
26/02/2013
Date of last participant enrolment
Anticipated
Actual
25/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5902 0
4108

Funding & Sponsors
Funding source category [1] 286210 0
University
Name [1] 286210 0
Griffith Health Institute
Country [1] 286210 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University
Kessels Road
Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 285019 0
Hospital
Name [1] 285019 0
Queen Elisabeth II Hospital
Address [1] 285019 0
Queen Elisabeth II Hospital
Cnr Kessels & Troughton Roads
Coopers Plains, QLD 4108
Country [1] 285019 0
Australia
Secondary sponsor category [2] 285020 0
Hospital
Name [2] 285020 0
Robina Hospital
Address [2] 285020 0
Robina Hospital
2 Bayberry Lane,
Robina QLD 4226
Country [2] 285020 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288286 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 288286 0
Centres for Health Research
Princess Alexandra Hospital
Metro South Hospital and Health Service
Ipswich Road
Woolloongabba QLD 4102
Ethics committee country [1] 288286 0
Australia
Date submitted for ethics approval [1] 288286 0
12/09/2012
Approval date [1] 288286 0
17/10/2012
Ethics approval number [1] 288286 0
HREC/12/QPAH/449

Summary
Brief summary
Patients undergoing elective hip or knee replacement experience different levels of pain and anxiety before and after their surgery. Providing education to patients on strategies to help them manage the pain and anxiety they experience could help improve patients’ physical and psychological outcomes after surgery. This study hopes to test whether education provided to patients before surgery can assist in their management of pain and anxiety while undergoing hip or knee replacement. Patients who agree to participate in this study, will be randomly assigned to either receive a DVD with self-efficacy information and activities to take home combined with the usual pre-operative education (the ‘self-efficacy education intervention group’ [A]) OR receive the usual pre-operative education and care (without the DVD) only (the ‘routine care group [B]). Participants who are allocated to receive the DVD are asked to view this and perform the activities (ie., relaxation, breathing and imagery exercises) within 72 hours and then on three other occasions until their booked surgery. A research assistant (registered nurse) will call the ‘self-efficacy education intervention group’ [A] participants on the telephone after 72 hours and then again before admission to support their participation. All participants will be assessed for levels of pain, anxiety, self-efficacy at the first three time points (T0-2). Participants will also be asked to respond to a survey about their satisfaction with care in relation to pain management on the day of their discharge/day 4 post-operatively (T3). Ten to fourteen days following discharge (T4), patients will be contacted via telephone at a suitable time to rate their pain, anxiety and self-efficacy as well as their utilisation of health services and resources. Finally 6 weeks after surgery (T5), patients will be telephoned at a suitable time to rate their pain, anxiety, utilisation of health services and resources and utilisation of relaxation method(s). Apart from the day of surgery, all other time points (T0, T2-5) will record the use and frequency of pain medications via direct patient feedback or from the end-of-bed medication sheets. The time taken to complete the assessments at 6 time points will be approximately 10 – 15 minutes. The assessments will be in paper form, and participants will be required to respond to a series of questions.
Trial website
Trial related presentations / publications
In press Journal article

Cooke M, Walker R, Aitken L, Freeman A, Pavey S, Cantrill R. Pre-operative self-efficacy education vs. usual care for
patients undergoing joint replacement surgery: a pilot
2 randomised controlled trial. Scand J Caring Sci; 2015, doi: 10.1111/scs.12223
Public notes

Contacts
Principal investigator
Name 34876 0
Prof Marie Cooke
Address 34876 0
School of Nursing and Midwifery Kessels Road Griffith University Nathan QLD 4111
Country 34876 0
Australia
Phone 34876 0
61 7 3735 5253
Fax 34876 0
61 7 3735 7984
Email 34876 0
[email protected]
Contact person for public queries
Name 18123 0
Prof Marie Cooke
Address 18123 0
School of Nursing and Midwifery
Kessels Road
Griffith University
Nathan QLD 4111
Country 18123 0
Australia
Phone 18123 0
61 7 3735 5253
Fax 18123 0
61 7 3735 7984
Email 18123 0
[email protected]
Contact person for scientific queries
Name 9051 0
Prof Marie Cooke
Address 9051 0
School of Nursing and Midwifery
Kessels Road
Griffith University
Nathan QLD 4111
Country 9051 0
Australia
Phone 9051 0
61 7 3735 5253
Fax 9051 0
61 7 3735 7984
Email 9051 0
[email protected]

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