Abstract：
UNASSIGNED: A mixed-methods approach nested in a pilot three-arm randomised controlled trial (RCT) was conducted to evaluate the feasibility and acceptability of an intervention of progressive muscle relaxation with guided imagery (experimental group) compared to a neutral guided imagery placebo (active control group) and a group that did not receive any psychological intervention (passive control group). The purpose was to inform a future definitive RCT that will test its effectiveness. Qualitatively, this study examined patients and health professionals\' perspectives regarding the relaxation intervention, in order to assess the acceptability and applicability of relaxation as an adjuvant therapy.
UNASSIGNED: Participants must have had a diagnosis of diabetes and diabetic foot disease; one or two active hard-to-heal ulcers at the time of the assessment; and clinical levels of stress or anxiety or depression. Participants were randomised and assessed at three timepoints after the first hospital consultation for hard-to-heal diabetic foot ulcer (DFU).
UNASSIGNED: Rates of eligibility, recruitment, refusal, adherence to study protocol, participation in follow-up and dropout, and patients\' satisfaction with the relaxation intervention were assessed as primary outcomes. Secondary outcomes were DFU healing; patients\' DFU-related quality of life; physical and mental quality of life; perceived stress; emotional distress; adherence to DFU care; perceptions of DFU; as well as arterial systolic/diastolic pressure and heart rate.
UNASSIGNED: The results of this pilot study contributed to clarification and better elucidation of the benefits of relaxation techniques regarding patients\' HRQoL and DFU healing.
UNASSIGNED: Funding: This study was conducted at the Psychology Research Centre (CIPsi/UM) School of Psychology, University of Minho, Portugal and supported by the Foundation for Science and Technology (FCT) through the Portuguese State Budget (UIDB/01662/2020) and by a PhD fellowship from FCT assigned to GF (SFRH/BD/131780/2017) and an FCT grant (PTDC/PSI-GER/28163/2017) assigned to MGP. The authors have no conflicts of interest to declare.
UNASSIGNED: Participants must have had a diagnosis of diabetes and diabetic foot disease; one or two active hard-to-heal ulcers at the time of the assessment; and clinical levels of stress or anxiety or depression. Participants were randomised and assessed at three timepoints after the first hospital consultation for hard-to-heal diabetic foot ulcer (DFU).
UNASSIGNED: Rates of eligibility, recruitment, refusal, adherence to study protocol, participation in follow-up and dropout, and patients\' satisfaction with the relaxation intervention were assessed as primary outcomes. Secondary outcomes were DFU healing; patients\' DFU-related quality of life; physical and mental quality of life; perceived stress; emotional distress; adherence to DFU care; perceptions of DFU; as well as arterial systolic/diastolic pressure and heart rate.
UNASSIGNED: The results of this pilot study contributed to clarification and better elucidation of the benefits of relaxation techniques regarding patients\' HRQoL and DFU healing.
UNASSIGNED: Funding: This study was conducted at the Psychology Research Centre (CIPsi/UM) School of Psychology, University of Minho, Portugal and supported by the Foundation for Science and Technology (FCT) through the Portuguese State Budget (UIDB/01662/2020) and by a PhD fellowship from FCT assigned to GF (SFRH/BD/131780/2017) and an FCT grant (PTDC/PSI-GER/28163/2017) assigned to MGP. The authors have no conflicts of interest to declare.
摘要：
■在一项三臂随机对照试验（RCT）中进行了嵌套的混合方法方法，以评估采用引导图像进行渐进性肌肉松弛干预的可行性和可接受性与中性引导图像安慰剂（主动对照组）和未接受任何心理干预的组（被动对照组）相比。目的是通知未来确定的RCT，以测试其有效性。定性,这项研究调查了患者和卫生专业人员对放松干预的看法，以评估放松作为辅助治疗的可接受性和适用性。
参与者必须诊断为糖尿病和糖尿病足病；评估时的一个或两个活动性难以治愈的溃疡；以及压力或焦虑或抑郁的临床水平。参与者被随机分组，并在第一次医院咨询难以治愈的糖尿病足溃疡（DFU）后的三个时间点进行评估。
■资格率，招募,拒绝,遵守研究协议，参与后续行动和辍学，患者对放松干预的满意度被评估为主要结局.次要结果是DFU愈合；患者DFU相关生活质量；身心生活质量；感知压力；情绪困扰；对DFU护理的依从性；对DFU的感知；以及动脉收缩压/舒张压和心率。
■这项初步研究的结果有助于澄清和更好地阐明放松技术对患者HRQoL和DFU愈合的益处。
■资助：这项研究是在心理学研究中心（CIPsi/UM）心理学学院进行的，Minho大学,葡萄牙，并由科学和技术基金会（FCT）通过葡萄牙国家预算（UIDB/01662/2020）和FCT分配给GF的博士研究金（SFRH/BD/131780/2017）和FCT资助（PTDC/PSI-GER/28163/2017）分配给MGP。作者没有利益冲突要声明。
参与者必须诊断为糖尿病和糖尿病足病；评估时的一个或两个活动性难以治愈的溃疡；以及压力或焦虑或抑郁的临床水平。参与者被随机分组，并在第一次医院咨询难以治愈的糖尿病足溃疡（DFU）后的三个时间点进行评估。
■资格率，招募,拒绝,遵守研究协议，参与后续行动和辍学，患者对放松干预的满意度被评估为主要结局.次要结果是DFU愈合；患者DFU相关生活质量；身心生活质量；感知压力；情绪困扰；对DFU护理的依从性；对DFU的感知；以及动脉收缩压/舒张压和心率。
■这项初步研究的结果有助于澄清和更好地阐明放松技术对患者HRQoL和DFU愈合的益处。
■资助：这项研究是在心理学研究中心（CIPsi/UM）心理学学院进行的，Minho大学,葡萄牙，并由科学和技术基金会（FCT）通过葡萄牙国家预算（UIDB/01662/2020）和FCT分配给GF的博士研究金（SFRH/BD/131780/2017）和FCT资助（PTDC/PSI-GER/28163/2017）分配给MGP。作者没有利益冲突要声明。
