NCT05703087

Positive Cueing in Knee Arthroplasty.

The Effect of Positive Cueing in the Information Video for Patients Undergoing Total Knee Arthroplasty: a Feasibility Study for a Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee
• Psychological Stress
• Mental Stress

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2021-09-21
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2023-01-27
• Last updated: 2023-01-27

Locations

1 site across 1 country: Netherlands