Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2021-09-21
2021-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators conducted a feasibility study with the primary objective to assess the acceptability of the randomized controlled trial (RCT) procedure for participating patients. The secondary objective was to evaluate the rate of recruitment, the comprehensibility (do patients understand what is expected of them during the trial) and if there were any adjustments necessary to the design of the study. The outcome of the current feasibility study will be used to determine whether adjustments are required to the design of the RCT before we proceed.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Movement Pattern Biofeedback Training After Total Knee Arthroplasty
NCT03325062
Kinesiophobia, Pain, Functional Status and Self-Efficacy in Patients With Knee Osteoarthritis
NCT05036551
Optimizing Pain Self-Management in Total Knee Arthroplasty
NCT06038240
The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty
NCT05346822
Effects of a Perioperative Action Observation and Motor Imagery Training in Patients Undergoing Total Knee Arthroplasty
NCT05459766
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In radiology, anesthesiology, and pediatric departments multiple studies have been performed on reducing the perception of pain with the use of language and hypnosis. This led to the concept of positive cueing. With positive cueing, general language without negative suggestions is used in provided information and instructions about the management of potential discomfort. Correct use of positive cueing has been shown to improve patients' satisfaction and to decrease need for additional treatments (such as blood transfusion) after several medical procedures, whereas use of negative language (warning patients for pain or negative experiences) seems to result in higher pain and anxiety scores.
Before TKA, patients are informed about the procedure and the risk of complications. Positive cueing might positively influence perioperative anxiety symptoms and subsequently improve pain after TKA. The investigators plan to conduct a randomized controlled trial (RCT) to address the question whether the use of positive cueing in the information video for patients undergoing a primary TKA, compared to the standard care video, will reduce the level of preoperative symptoms of anxiety and improve pain coping styles.
To the knowledge of the reviewers, no previous studies addressed this topic. Hence, the feasibility of an RCT assessing the use of positive cueing in an information video for patients undergoing primary TKA is currently unclear. As such, this feasibility study was conducted with the primary objective to assess the acceptability of the RCT procedure for participating patients. Secondly, the rate of recruitment, the comprehensibility (do patients understand what is expected of them during the trial) and if there were any adjustments necessary to the design of the study were evaluated. The outcome of the current feasibility study will be used to determine whether adjustments are required to the design of the RCT before the investigators proceed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard information video before primary total knee arthroplasty
Information video (about procedure, complications, rehabilitation) shown to the participants before TKA in the OLVG.
No interventions assigned to this group
Positive cueing in the information video before a primary total knee arthroplasty
The information video was adapted from the existing standard information video used in OLVG. The concept of positive cueing was applied to the standard video by an expert team including a psychiatrist and clinical psychologist. Illustrations which were incomprehensible or with negative associations were removed.
Four rules were followed to use positive cueing:
1. make patients aware that they are able to influence their own recovery process,
2. be descriptive in explanations; objectively describe the performed procedure, name equivalent, not negatively charged feelings,
3. explain why specific steps and actions during the procedure are performed, so the patients understand what is going to happen,
4. do not use medical langue, but use accessible, understandable language instead.
Positive cueing in the information video before a primary TKA
Two weeks before the surgery, in the outpatient clinic (during their preoperative appointment), the pre-surgery information video was shown to the patients. Patients were randomly allocated to either the positive cueing group (intervention) or the standard care group (control) with Castor EDC (14) using a variable block randomization model. Patients did not know whether they watched the adapted video or the standard video.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Positive cueing in the information video before a primary TKA
Two weeks before the surgery, in the outpatient clinic (during their preoperative appointment), the pre-surgery information video was shown to the patients. Patients were randomly allocated to either the positive cueing group (intervention) or the standard care group (control) with Castor EDC (14) using a variable block randomization model. Patients did not know whether they watched the adapted video or the standard video.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* end-stage knee osteoarthritis for which participants were scheduled for a TKA
* sufficient Dutch languages skills to understand the information video
* able to fill out the questionnaires.
Exclusion Criteria
* not sufficient Dutch languages skills to understand the information video
* not able to fill out the questionnaires.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Onze Lieve Vrouwe Gasthuis
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Leiden University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rudolf W Poolman, MD PhD
Clinical Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LUMC
Leiden, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WO 21.122
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.