Factors Affecting Guided Imagery Response in Total Knee Replacement

全膝关节置换术中影响引导想象反应的因素

• 批准号: 7788884
• 负责人: ANN M JACOBSON
• 金额: $ 22.1万
• 依托单位: KENT STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-01 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7788884
• 关键词: Address; Affect; Affective; Alternative Therapies; Attention; Behavioral; Books; Characteristics; Clinical; Clinical Trials; Complementary therapies; Control Groups; Data; Development; Dimensions; Dose; Dropout; Effectiveness; Emotional; Evaluation; Expectancy; Feasibility Studies; Frequencies; Future; Goals; Guided imagery; Health; Image; Imagery; Individual; Intervention; Intervention Studies; Interview; Measures; Mediating; Mediator of activation protein; Methods; Mind-Body Intervention; Modeling; Nature; Operative Surgical Procedures; Outcome; Outcome Study; Pain; Participant; Patients; Perception; Persons; Phase; Physical Function; Placebo Control; Placebos; Population; Postoperative Period; Procedures; Psyche structure; Published Comment; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Regression Analysis; Rehabilitation therapy; Reporting; Research; Research Design; Sample Size; Sampling; Schedule; Standardization; Techniques; Testing; Theoretical model; Time; Treatment Protocols; United States; Variant; Writing; base; body-mind; clinical effect; design; distraction; effectiveness clinical trial; experience; functional outcomes; group intervention; improved; insight; instrument; knee pain; knee replacement arthroplasty; psychologic; psychological distress; randomized placebo controlled trial; response; success

DESCRIPTION (provided by applicant): Total knee replacement (TKR) is the third most frequently performed surgery in the United States. Although TKR has demonstrated positive outcomes, a significant proportion of patients report continuing pain, functional limitations, and dissatisfaction up to two years following the surgery. Complementary and alternative strategies that influence mind-body dimensions of the TKR experience have potential for improving outcomes in this large population. Guided imagery (GI) is a widely used mind-body technique that may be effective in promoting surgery outcomes. .Studies of GI for clinical conditions have had inconsistent results and lack generalizability due to absent or inappropriate controls, inadequate or absent theoretical frameworks, and lack of standardization. Sufficiently powered, randomized, controlled trials (RCTs) of the effect of GI and explanation of its mechanism of action are needed to address NCCAM's objective to elucidate emotional, behavioral, and psychological mechanisms of mind-body interventions. Preliminary data are needed for design of a full scale trial include feasibility and acceptability of GI in the clinical population and standardization of the GI and placebo control treatment. The proposed exploratory project will use a mixed method design to produce pilot data for a subsequent randomized, placebo-controlled trial of the effects of GI in patients undergoing total knee replacement: The specific aims are to: 1). Generate estimates of effect sizes and assess feasibility of procedures for a future RCT testing a model of a standardized, prerecorded guided imagery intervention on functional outcomes of TKR; 2). Elucidate the GI responder mechanism through analysis of the effect of imaging ability and other potential moderators on guided imagery's effects on TKR outcomes; 3). Analyze the effect of guided imagery on outcome expectancy, psychological distress, and rehabilitation commitment as mediators on TKR outcomes; and 4). Identify patients' perspectives of receiving, and participating in a study of, guided imagery intervention for total knee replacement surgery (TKR). 82 persons scheduled to undergo TKR will be randomly assigned to either the treatment or placebo control group. The treatment will consist of listening to recorded GI scripts developed for this study for 2 weeks before and after surgery. The placebo treatment will be listening to segments of an audio book. The effect of GI on knee pain and function will be assessed at 3 intervals following the surgery and mediating/moderating effects of psychologic affective and dispositional attributes would be examined. A subsequent qualitative phase will be aimed at providing further explanations of relationships among guided imagery and the study variables, as well as analyzing participant benefit and burden and feasibility and acceptability of the study and the intervention. PUBLIC HEALTH RELEVANCE: Guided imagery is a widely used complementary and alternative therapy for numerous health conditions. Research is needed to determine whether this popular technique has beneficial clinical effects. This project will provide preliminary data needed to conduct a rigorous scientific trial testing the effectiveness of guided imagery for persons having total knee replacement, the third most frequently performed surgery in the United States.

描述（由申请人提供）：总膝盖置换（TKR）是美国第三次经常进行的手术。尽管TKR表现出积极的结果，但大部分患者报告了手术后长达两年的持续疼痛，功能局限性和不满意。影响TKR体验的思维尺寸的互补和替代策略具有改善这一人群中结果的潜力。引导图像（GI）是一种广泛使用的思维体技术，可以有效促进手术结果。临床条件中的GI的研究结果不一致，由于缺乏或不适当的控制，缺乏理论框架或缺乏标准化而缺乏普遍性。需要足够的动力，随机，对照试验（RCT）对GI的影响以及对其作用机制的解释，以解决NCCAM的目标，以阐明心理干预的情绪，行为和心理机制。设计完整试验需要初步数据，包括GI在临床人群中的可行性和可接受性以及GI和安慰剂控制治疗的标准化。拟议的探索性项目将使用混合方法设计来生成试验数据，以对GI对接受总膝关节置换的患者的影响进行随后的随机安慰剂对照试验：具体目的是：1）。生成效应大小的估计值，并评估程序对未来RCT测试的可行性，该模型是标准化的，预先记录的指导成像干预TKR功能结果的模型； 2）。通过分析成像能力和其他潜在主持人对指导成像对TKR结果的影响的影响，阐明了GI响应机制； 3）。分析有指导图像对预期结果，心理困扰和康复承诺的影响，以作为TKR结果的调解人；和4）。确定患者接受的观点，并参与对全膝关节置换手术（TKR）的指导图像干预的研究。计划经历TKR的82人将随机分配给治疗或安慰剂对照组。该处理将包括聆听为本研究开发的记录的GI脚本，持续了两周前和手术后。安慰剂治疗将听听音频书的细分市场。将在手术后3个间隔评估GI对膝盖疼痛和功能的影响，并将检查心理情感和性格属性的介导/调节作用。随后的定性阶段将旨在提供有关指导图像和研究变量之间关系的进一步解释，并分析参与者的福利和负担以及研究的可行性和可接受性和干预措施。 公共卫生相关性：指导图像是一种针对多种健康状况的广泛使用的补充和替代疗法。需要研究以确定这种流行技术是否具有有益的临床效果。该项目将提供进行严格的科学试验所需的初步数据，该试验测试指导图像的有效性对于全膝关节更换的人，这是美国第三次经常进行的手术。