Thematic analysis of participants’ experiences revealed that all patients and caregivers who accepted to collaborate in this study, were satisfied and showed a positive opinion about the effectiveness of the two stress reduction interventions for psychological well being and DFU healing progression.
Interviews with patients yielded four key themes common and caregivers: (1) perspectives on the intervention, (2) intervention effectiveness, (3) the role of psychology in the DFU treatment, and (4) emotions and consequences associated with the DFU. Regarding the perspectives on the intervention, patients had never experienced relaxation or hypnosis sessions, but they reported that the sessions were satisfactory, beneficial, and important because they were good for their minds as a complement to medical treatment (T.G.1), and helped them to accept the complexity of DFU (T.G.2). Overall, caregivers had no previous knowledge about the interventions, considering sessions as very useful and an important complement to the medical intervention, especially because they notice differences in their family members. Interventions were well received by patients and perceived as effective by caregivers, indicating a high level of acceptability that will promote adherence to the psychological intervention if available in clinical settings/contexts.
Patients and caregivers reported some suggestions to improve the implementation of this type of intervention complementing medical treatment. All patients suggested a greater number of sessions defined according to an initial personalized assessment, and defend the existence of a private space for the sessions or, according to caregivers, that the intervention should be implemented in a non-hospital setting and should include more sessions. Importantly, this intervention should be available in an initial phase of treatment, essentially before the patient’s amputation (T.G.2). These suggestions are extremely useful for informing decision-makers and hospital administrators.
Patients that received PMR + GI also reported practicing the intervention exercises at home, on their own initiative, thus denoting greater adherence to the sessions. Also, patients that received H + GI claimed that those sessions should be included in standard treatment for DFU, supporting its evidence-based beneficial clinical impact. [36] A substantial body of research has demonstrated the efficacy of hypnosis as part of the integrative treatment of many conditions that traditional medicine has found difficult to treat. [37] In fact, hypnosis has shown not only to reduce anxiety in medical conditions but also change physiological parameters, [38] being effective in the management of diabetes, including regulation of blood sugar. [23] Regarding wounds, hypnosis has been shown to be effective in reducing pain in children with burns, but not in reducing pain intensity or accelerating wound healing; [39] and was also effective in accelerating the healing of postoperative wounds. [40] Although, so far, no studies have shown the effectiveness of hypnosis in accelerating DFU healing, the opinion of patients and caregivers from the H + GI and PMR + GI groups shows that the sessions have been helpful at various levels of functioning in DFU patients.
Regarding the intervention effectiveness, patients and caregivers from both groups reported physical, behavioral, psychological, and interpersonal changes, associated with the two interventions. In addition to the evolution of the DFU, physical changes such as better blood circulation, ability to walk and body balance (T.G.1), better glycemic control, less pain, and breathing control (T.G. 2) were reported highlighting the benefits of these two types of psychological intervention in this population. [22, 25, 41, 24]
In terms of psychological changes, patients reported a feeling of calm, lightness or relaxation, more positive thinking, better sleep quality, and acceptance of the disease. These changes/ improvements in the mood state were also noticed by caregivers who felt their relative was calmer, relaxed, and peaceful (T.G.1), patient/tolerant, happy, and less demanding or grumpy (T.G.2). Psychological interventions don't only have positive effects in reducing negative emotions, but also may promote the development of a cognitive and emotional process of diabetes acceptance as a chronic disease, thus helping patients to cope with it.
Behavioral improvements were associated with adherence to self-care behaviors such as a foot rest and avoidance of farm work/gardening. One patient, even reported a reduction in alcohol and tobacco consumption, and a healthier diet – evidenced by the caregiver's statement. Changes in interpersonal relationships were also perceived by patients and caregivers, as patients reported feeling more patient and less offensive, and caregivers corroborated those changes. Foot ulcers in people with diabetes are associated with high levels of morbidity, with symptoms of anxiety and depression being the most prevalent. [8–9, 42–43] Therefore, understandably, psychological interventions had almost a direct, immediate positive effect and an indirect impact on medication adherence, empowering patients to engage in self-care behaviors, and boosting overall mood. [42]
Regarding the duration of the changes resulting from interventions, participants’ opinions differed in both groups, ranging from effects that only lasted during the session to long-term effects after the end of the intervention. However, T.G.2 patients and caregivers reported longer effects, as most of them expressed that the effect remained over time, and was visible till the present moment. In fact, the use of hypnosis for the DFU treatment has been found to promote positive behavioral changes, with longer lasting effects. According to Kohen [44] 85% of patients that received hypnosis years ago reported prolonged feelings of pain relief as a result of self-hypnosis techniques. Wood and colleagues [45] demonstrated that the hypnotic intervention altered T-cell activity what may explain the longer effects hypnosis may have, regarding healing.
Most patients were aware of the importance of psychological interventions for the DFU treatment - reflecting a belief in the mind-body connection – although some patients may feel reluctant to participate in psychological interventions due to prejudice or shame, or even because they feel emotionally overwhelmed by the emotional consequences of the disease. Therefore, the moment when the intervention is made available is extremely important [42] Caregivers also highlighted the role of psychological status for successful treatments, determination, positive thinking (T.G.1), and acceptance of the disease (T.G.2), highlighting caregivers' awareness of the importance of psychological intervention to help the patient accept the disease. [46]
Patients, especially those from T.G.1, reported that DFU was a source of negative emotions and consequences, such as sadness, anger, revolt, and anguish, living with the fear of amputation and trauma, [8–9, 43] and dealing with the impossibility to work. Caregivers from both groups stressed the fear of amputation felt by patients. As previously suggested in the literature, [47] people with diabetes fear amputation worse than death. Thus, in the face of this negative emotionality, the role of psychological intervention is even more useful and relevant to improve the patient's general wellbeing, reduce symptoms of anxiety and depression, and stimulate emotional regulation [42] particularly when patients are unemployed, inactive, with their QoL compromised due the DFU. [43]
Regarding consequences associated with the DFU, caregivers highlighted the impact on the patient's daily life, resulting in inactivity, isolation, depression (T.G.1), unemployment and lack of social activities for the caregiver (T.G. 1 and T.G. 2), as shown by previous research [14–15]. This whole burden scenario is exacerbated when the patient is amputated, [48] which is probably why a caregiver suggested that the intervention should be provided to patients before the amputation surgery.
In addition to the four themes identical to patients, one more theme emerged from the caregivers’ interviews, particularly (5) promotion of self-care behaviors, that refers to the demands of assuring patents’ self-care behaviors, such as the concern to warrant patients attend appointments or take the prescribed medication at the appropriate time (T.G.1). However, this category was not visible in the caregivers of patients from T.G.2.
Overall, psychological interventions aimed to reduce levels of suffering, such as depression, anxiety, and stress, higher in patients with DFU, [8–9, 43] since these psychological factors negatively affecting wound healing [49–50]. In addition to the various positive and beneficial changes found in the behavioral, emotional, and interpersonal functioning of patients, psychological interventions had effects in improving ulcer healing in some patients, and in reducing symptoms of psychological morbidity in all patients. These results highlight the positive effects of both interventions (relaxation or hypnosis) on the patients' general emotional state, ulcer healing and general wellbeing.
Limitations
This study has some limitations that need to be acknowledged such as the number of patients and caregivers involved. Although the analysis of the interviews indicated a level of coherence regarding the emerging themes, the inclusion of more participants could provide more in-depth information. All psychologists who performed the stress reduction techniques were highly trained, but there might have been bias regarding the person of the therapist and therapist ‘s gender that was not controlled for. Also, only patients from two hospitals in the north of Portugal were involved. Therefore, more studies involving more patients and caregivers from other hospitals are needed, in order to better understand the impact of stress reduction techniques on DFU healing and emotional wellbeing.
Implications for clinical practice
Psychological interventions should be included as standard treatment for DFU patients in addition to clinical/medical treatment. Both patients and caregivers reported a positive evolution and improvements in DFU healing during and after sessions. Patients and caregivers also reported psychological improvements after treatment. Thus, in addition to previous positive results from both relaxation and hypnosis training techniques in patients with DFU, [25] this study shows promising and encouraging results for decision-makers to implement a specialized psychological support/consulting service for DFU patients in multidisciplinary diabetic foot clinics.
As for the characteristics of the stress reduction interventions, future interventions should include more than four sessions, tailored to the patient’s psychological assessment. In order to increase the benefits of such interventions, stress reduction techniques may also be taught so that patients may learn to practice self-relaxation and auto-hypnosis exercises, at home. To promote home practice on a daily basis, sessions could be recorded and made available to patients who should be coached in self-relaxation and self-hypnosis, using a taped script or a smartphone application. Further research should assess the effectiveness of included post-hypnotic suggestions as an important part of scripts for self-hypnosis and self-relaxation.
Distressed caregivers may also be offered a support group to help reduce overload, especially among caregivers who care for patients who suffered an amputation, have a chronic illness, report physical symptoms and have been caregivers for several years. [48]
Future studies should address the dyad patient-caregiver, over time, and better understand how muscle relaxation and hypnosis promote QoL, adherence to medical treatment, and self-care behaviors so that a psychological intervention protocol may be created to answer patients’ needs, as well the needs of informal caregivers, the medical team, and psychologists when caring for patients with a DFU.