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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Population
patients undergoing digital replantation after traumatic amputation
Methods
two-arm randomized controlled clinical trial; control group receives standard postoperative nursing care, intervention group receives eMBCT for 4 weeks
Duration
4 weeks
Funding
Unclear

Background

Traumatic amputations are common traumatic injuries that require digital replantation to restore the form, function, and sensation of the hand. The post-surgical survival of replanted digits is influenced by multiple factors, including psychological factors such as posttraumatic stress disorder (PTSD), anxiety, and depression. Mindfulness-based cognitive therapy (MBCT) is considered a potential intervention to address such emotional distress. Traditionally, MBCT involves an 8-week face-to-face group format. Due to feasibility concerns regarding implementation and patient adherence, this study proposes a modified 4-week online version, referred to as brief online MBCT (eMBCT).

Methods

This study is a two-arm randomized controlled clinical trial. The control group will receive standard postoperative nursing care, while the intervention group will receive the eMBCT for 4 weeks. The primary outcome measure is PTSD symptom severity, assessed using the Stanford Acute Stress Reaction Questionnaire (SASRQ). Secondary outcomes include the Connor-Davidson Resilience Scale (CD-RISC), the General Self-Efficacy Scale (GSES), the EuroQol Five-Dimensional Health Scale (EQ-5D), and postoperative recovery status.

Discussion

This study aims to investigate the effects of a brief eMBCT program on PTSD symptoms, psychological resilience, self-efficacy, and clinical outcomes-specifically the incidence of vascular crisis and hand function recovery-in patients undergoing digital replantation.

Trial registration

ChiCTR2500101285 [Chinese Clinical Trial Registry; registered on 23 April 2025].

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