Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer, in Physiological Indicators of Healing Prognosis and Quality of Life: a Randomized Longitudinal Trial With a Nested Qualitative Study of Effectiveness Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 6
- 主要终点
- Impact of the DFU on patients' quality of life
研究概览
简要总结
Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Research suggests that psychological factors may play an important role in DFU healing. Relaxation and hypnosis seem to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular chronic wounds such as DFU.
This study will evaluate the efficacy of relaxation and hypnosis, both with guided imagery, in DFU healing, physiological indicators (inflammatory, metabolic, oxidative stress, angiogenic, and miRNA biomarkers) of wound healing prognosis, and QoL, in patients with diabetic foot and a chronic ulcer. This study is a Randomized Controlled Study of a Psychological Intervention that aims to evaluate the efficiency of a muscle relaxation intervention with guided imagery (experimental group - EG1) compare to a hypnosis intervention with guided imagery (experimental group - EG2) and a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG).
This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation and hypnosis interventions, in order to check its effectiveness; as well as the perspectives of informal caregivers on this adjuvant therapys.
Participants must have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic active ulcers at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the four conditions - EG1, EG2, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted independently with patients that completed the relaxation, hypnosis, and placebo sessions, and with the informal caregivers who provided them the DFU care. The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.
详细描述
General Aim:
This RCT aims to assess the effectiveness of a muscle relaxation intervention with guided imagery (EG1) compared to hypnosis with guided imagery intervention (EG2) and a neutral guided imagery placebo (ACG) and a group that does not receive any psychological intervention (PCG), in DFU healing, physiological indicators of healing prognosis, and quality of life (QoL), in patients with diabetic foot and a chronic ulcer.
This study will also examine, qualitatively, the perspectives of patients and their respective family caregivers regarding the interventions (EG1 and EG2) and placebo sessions in order to check the treatments' effectiveness.
Specific aim:
- To compare the impact of both experimental groups (EG1 and EG2) on psychological stress markers, in DFU healing, physiological indicators of healing prognosis, and QoL compared to the (PCG); between pre and post-intervention in the EG1 and EG2, controlling for clinical and sociodemographic variables, adherence to DFU care, and patients' literacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor) Eligible participants will be randomized into the four groups into blocks of variable size, multiples of three; and will be stratified according to: i) data collection site; ii) Chronic Renal Disease (CRD); and iii) Peripheral Arterial Disease (PAD); since CRD and PAD are factors of poor prognosis in the DFU healing (Ferreira et al., 2014). This procedure will be performed using an online random number generator by an independent researcher unaware of the numeric coding for each group. After this procedure, it will not be possible to conceal the group to which the patient belongs from the researcher that will perform the psychological and placebo interventions. However, health professionals will be blinded during the entire procedure as they will only fill in the clinical questionnaire (doctors) and the RESVECH 2.0 (nurses), which assesses the DFU healing.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older;
- •Diabetes Mellitus diagnosis;
- •Diagnosis of Diabetic Foot;
- •Having one or two active chronic ulcers (> 6 weeks and < 14 weeks) at the time of baseline assessment;
- •Being followed at the Multidisciplinary Consultation of the Diabetic Foot from the Centro Hospitalar Universitário do Porto (CHUP), at the Diabetic Foot Clinic from the Centro Hospitalar do Tâmega e Sousa (CHTS) and from the Multidisciplinary Consultation of the Diabetic Foot of the Hospital de Braga (HB);
- •Presenting clinical levels of stress (scores > 13 for males and > 17 for females on the Perceived Stress Scale) or anxiety or depression (scores > 11 on Hospital Anxiety and Depression Scale);
- •Providing written informed consent.
排除标准
- •The active DFU at the time of the assessment being a relapse;
- •Having more than two DFUs at the time of baseline assessment;
- •Being on hemodialysis treatment;
- •Presence of psychosis or dementia described in the patient's medical record;
- •Having cancer disease;
- •Having undergone a transplant;
- •Receiving psychological counselling at the time of the assessment.
- •For the RCT qualitative nested study, twelve participants that completed at least 75% of the treatment or placebo sessions, and that report having a informal/ family caregiver will be invite the participate. Participants will be selected according to the following criteria:
- •Two typical cases of successful and unsuccessful patients with neuropathic foot, defined by the presence of neuropathic pain (e.g., heat, tingling, electrical shock), presence of distal pulses by palpation, and loss of protective sensitivity;
- •Two typical cases of successful and unsuccessful patients with neuroischemic foot, defined by the presence of peripheral artery disease, intense-variable pain, absence of distal pulses by palpation, and variable protective sensitivity.
结局指标
主要结局
Impact of the DFU on patients' quality of life
时间窗: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2)
The Diabetic Foot Ulcer Scale-Short Form (DFS-SF; Bann, Fehnel, \& Gagnon, 2003; Research version by Pereira et al., 2022) will be used to assess patients´ DFU-related quality of life. Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better DFU-related quality of life.
Mental quality of life
时间窗: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2)
The Short-Form Health Survey (SF-36; Ferreira, 1998; Ferreira, Ferreira, \& Pereira, 2012) will be administered to assess patients' mental health-related quality of life. Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better mental quality of life.
miRNA markers
时间窗: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2)
miRNA-21 and miRNA-155 will be assessed with SYBR Green technology, using the RNU6B gene as control.
Degree of DFU healing
时间窗: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2)
The degree of DFU healing will be assessed with the Portuguese version of "Resultados esperados de la valoración y evolución de la cicatrización de las heridas crónicas" Scale \[Expected results of the evaluation and evolution of the healing of chronic wounds Scale - RESVECH 2.0\] (Marques, 2015). The scores range from 0 to 35, where zero indicates complete healing.
Physical quality of life
时间窗: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2)
The Short-Form Health Survey (SF-36; Ferreira, 1998; Ferreira, Ferreira, \& Pereira, 2012) will be administered to assess patients' physical health-related quality of life. Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better physical quality of life.
Metabolic marker
时间窗: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2)
The quantification of HbA1c in the plasma will be performed using the competitive inhibition enzyme immunoassay Cloud Clone Corp
Angiogenic markers
时间窗: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2)
Angiopoietin-2, EGF, FGF-basic, PECAM-1, PIGF, and VEGF levels will be assessed in the plasma using a LEGENDplexTM Human Angiogenesis Panel 1 Mix and Match (9-plex).
Immune cells
时间窗: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2)
Blood leukocyte and B and T-cell populations will be assessed in the whole blood by flow cytometry and automated hematological cell counter.
Inflammatory markers
时间窗: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2)
IL-6, IL-8, and TNF-a levels will be evaluated in the plasma using a LEGENDplexTM Human Angiogenesis Panel 1 Mix and Match (9-plex). Blood lymphocyte populations will be assessed in the whole blood by flow cytometry and automated hematological cell counter.
次要结局
- Anxiety symptoms(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2))
- Representations regarding the DFU(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2))
- Perceived Stress(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2))
- Emotional Distress(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2))
- Depression symptoms(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2))
研究者
Maria da Graça Pereira
Associate Professor with Aggregation of School of Psychology
University of Minho