Clinical trial NCT05703087: Positive Cueing in Knee Arthroplasty.
Official title: The Effect of Positive Cueing in the Information Video for Patients Undergoing Total Knee Arthroplasty: a Feasibility Study for a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Psychological Stress
Mental Stress
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouwe Gasthuis
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2023-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center feasibility study. We compared the use of positive cueing in the information video before a primary total knee arthorplasty (TKA) with the standard information video.
Primary purpose: TREATMENT

Brief summary: To the knowledge of the investigators, the feasibility of an RCT assessing the use of positive cueing in an information video for patients undergoing primary TKA is currently unclear.

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.

Detailed description: Even though total knee arthroplasty (TKA) is a cost-effective treatment, 10 - 34% of the patients report pain and discomfort up to two years after the procedure. Preoperative symptoms of anxiety and/or depression (which is present in approximately 10 - 58.6% of TKA patients seem to be related to poor pain coping techniques, which can lead to higher levels of pain up to two years after surgery. Our previous systematic review showed that a reduction of preoperative symptoms of anxiety and depression may lead to a reduction of postoperative pain after TKA.

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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* 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 receiving TKA for osteoarthritis of the knee
* not sufficient Dutch languages skills to understand the information video
* not able to fill out the questionnaires.

Primary outcomes:
measure: Feasibility outcome measure: acceptibility.
timeFrame: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.
Secondary outcomes:
measure: Feasibility outcome measure: rate of recruitment
timeFrame: The number of the patients on the waiting list for total knee arthroplasty and the included patients were assessed two weeks before surgery, during the outpatient clinic visit.
measure: Feasibility outcome measure: comprehensibility
timeFrame: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.
measure: Feasibility outcome measure:patients' feedback to the current protocol.
timeFrame: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC
Study officials:
References: