The Effect of Positive Cueing in the Information Video for Patients Undergoing Total Knee Arthroplasty: a Feasibility Study for a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility outcome measure: acceptibility.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard information video before primary total knee arthroplasty
Information video (about procedure, complications, rehabilitation) shown to the participants before TKA in the OLVG.
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:
- make patients aware that they are able to influence their own recovery process,
- be descriptive in explanations; objectively describe the performed procedure, name equivalent, not negatively charged feelings,
- explain why specific steps and actions during the procedure are performed, so the patients understand what is going to happen,
- do not use medical langue, but use accessible, understandable language instead.
干预措施: Positive cueing in the information video before a primary TKA (Behavioral)
结局指标
主要结局
Feasibility outcome measure: acceptibility.
时间窗: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.
The primary feasibility outcome score was the acceptability to participate, assessed with a developed questionnaire. The investigators conducted a questionnaire about the experience of the participants with a Likart scale 1 - 5, existing of 4 questions. A total score of 12 or higher was interpreted as acceptable since the patient seemed have a positive experience according to the questionnaire. As part of the primary outcome measure (acceptibility), we monitored the time it took a patient to participate in the study. The study should not take more than one hour to be acceptable.
次要结局
- Feasibility outcome measure: comprehensibility(During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.)
- Feasibility outcome measure: rate of recruitment(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.)
- Feasibility outcome measure:patients' feedback to the current protocol.(During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.)
研究者
Rudolf W Poolman, MD PhD
Clinical Professor
Leiden University Medical Center