Relaxation intervention to improve diabetic foot ulcer healing: protocol for a pilot study with a nested qualitative study.

IF 1.5 4区医学 Q3 DERMATOLOGY

Journal of wound care Pub Date : 2024-07-01 DOI:10.12968/jowc.2022.0175

Gabriela Ferreira, André Carvalho, M Graça Pereira

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引用次数: 0

Abstract

Objective: 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.

Method: 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).

Results: 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.

Conclusion: The results of this pilot study contributed to clarification and better elucidation of the benefits of relaxation techniques regarding patients' HRQoL and DFU healing.

Declaration of interest: 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.

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改善糖尿病足溃疡愈合的放松干预：嵌套定性研究试点研究方案。

研究目的在一项三臂随机对照试验（RCT）中嵌套了一种混合方法，以评估通过引导想象进行渐进式肌肉放松干预（实验组）与中性引导想象安慰剂（主动对照组）和未接受任何心理干预的一组（被动对照组）相比的可行性和可接受性。其目的是为未来的明确 RCT 提供信息，以检验其有效性。本研究从定性角度考察了患者和医疗专业人员对放松干预的看法，以评估放松作为辅助疗法的可接受性和适用性：参与者必须确诊患有糖尿病和糖尿病足病；评估时有一个或两个难以愈合的活动性溃疡；有临床水平的压力、焦虑或抑郁。参与者在首次因糖尿病足溃疡（DFU）住院就诊后的三个时间点接受随机评估：评估的主要结果包括参与者的资格审查率、招募率、拒绝率、对研究方案的遵守率、参与随访率和退出率，以及患者对放松干预的满意度。次要结果包括DFU愈合、患者与DFU相关的生活质量、身体和精神生活质量、感知压力、情绪困扰、DFU护理的依从性、对DFU的看法以及动脉收缩压/舒张压和心率：这项试点研究的结果有助于澄清和更好地阐明放松技术对患者的 HRQoL 和 DFU 愈合的益处：资金：本研究在葡萄牙米尼奥大学心理学学院心理学研究中心（CIPsi/UM）进行，由科学技术基金会（FCT）通过葡萄牙国家预算（UIDB/01662/2020）以及FCT分配给GF的博士奖学金（SFRH/BD/131780/2017）和分配给MGP的FCT赠款（PTDC/PSI-GER/28163/2017）支持。作者无利益冲突需要声明。

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来源期刊

Journal of wound care DERMATOLOGY-

CiteScore

2.90

自引率

10.50%

发文量

215

期刊介绍： Journal of Wound Care (JWC) is the definitive wound-care journal and the leading source of up-to-date research and clinical information on everything related to tissue viability. The journal was first launched in 1992 and aimed at catering to the needs of the multidisciplinary team. Published monthly, the journal’s international audience includes nurses, doctors and researchers specialising in wound management and tissue viability, as well as generalists wishing to enhance their practice. In addition to cutting edge and state-of-the-art research and practice articles, JWC also covers topics related to wound-care management, education and novel therapies, as well as JWC cases supplements, a supplement dedicated solely to case reports and case series in wound care. All articles are rigorously peer-reviewed by a panel of international experts, comprised of clinicians, nurses and researchers. Specifically, JWC publishes: High quality evidence on all aspects of wound care, including leg ulcers, pressure ulcers, the diabetic foot, burns, surgical wounds, wound infection and more The latest developments and innovations in wound care through both preclinical and preliminary clinical trials of potential new treatments worldwide In-depth prospective studies of new treatment applications, as well as high-level research evidence on existing treatments Clinical case studies providing information on how to deal with complex wounds Comprehensive literature reviews on current concepts and practice, including cost-effectiveness Updates on the activities of wound care societies around the world.