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恐惧回避干预对经皮冠状动脉介入治疗术后患者运动恐惧和自我效能的影响:一项临床随机对照试验的研究方案

The effect of fear-avoidance intervention on kinesiophobia and self-efficacy in patients after percutaneous coronary intervention: study protocol for a clinical randomized controlled trial.

作者信息

Li Qi, Yan Lingjun, Xing Wenhui, Zhou Ce, Li Yu, Wan Boya, Piao Jingjing, Gu Yanmei

机构信息

Faculty of Nursing, HeBei University of Chinese Medicine, Xingyuan Rd, LuQuan, No.3 Xingyuan Rd, LuQuan, Shijiazhuang, 050200, Hebei, China.

Current Address: The Third Hospital of Shijiazhuang City, Shijiazhuang, Hebei Province, China.

出版信息

Trials. 2024 Jul 31;25(1):517. doi: 10.1186/s13063-024-08349-6.

Abstract

BACKGROUND

Kinesiophobia after percutaneous coronary intervention (PCI) may lead to decreased compliance with rehabilitation exercises. Effective interventions are essential to overcome kinesiophobia after PCI. The aim of this trial is to investigate the clinical effects of an intervention based on the fear-avoidance model (FAM) on kinesiophobia in post-PCI patients.

METHODS

Eighty participants will be recruited in the Department of Cardiology in Hebei Provincial People's Hospital. And they will be randomly allocated to the test group and undergo a 5-day step-to-step intervention. The primary outcome will be the scores of a scale on kinesiophobia. Secondary outcome measures included self-efficacy for exercise, psychogenic anxiety, and the occurrence of cardiovascular adverse events. Primary and secondary outcome data will be collected at baseline (t), on the day of discharge (t), and one month after discharge (t).

DISCUSSION

The effectiveness of an intervention based on the FAM to increase exercise self-efficacy and decrease kinesiophobia in post-PCI patients will be demonstrated. The findings of this study will facilitate post-PCI patients to participate in cardiac rehabilitation.

TRIAL REGISTRATION

ChiCTR2200065649 Effect of an intervention based on the fear-avoidance model on exercise fear in patients after percutaneous coronary intervention. Registered on November 10, 2022.

摘要

背景

经皮冠状动脉介入治疗(PCI)后运动恐惧可能导致康复锻炼依从性下降。有效的干预措施对于克服PCI后的运动恐惧至关重要。本试验的目的是研究基于恐惧回避模型(FAM)的干预对PCI术后患者运动恐惧的临床效果。

方法

将在河北省人民医院心内科招募80名参与者。他们将被随机分配到试验组,并接受为期5天的逐步干预。主要结局将是运动恐惧量表的得分。次要结局指标包括运动自我效能感、心理性焦虑以及心血管不良事件的发生情况。主要和次要结局数据将在基线(t₁)、出院当天(t₂)和出院后1个月(t₃)收集。

讨论

将证明基于FAM的干预在提高PCI术后患者运动自我效能感和降低运动恐惧方面的有效性。本研究的结果将有助于PCI术后患者参与心脏康复。

试验注册

ChiCTR2200065649 基于恐惧回避模型的干预对经皮冠状动脉介入治疗后患者运动恐惧的影响。于2022年11月10日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fe9/11293134/764ca21e2e86/13063_2024_8349_Fig1_HTML.jpg

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