NCT04652999

Relaxation Intervention in Patients With Diabetic Foot Ulcer

Relaxation Intervention in Patients With Diabetic Foot Ulcer: A Pilot Randomized Controlled Trial With a Nested Qualitative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Minho · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. Psychological interventions can contribute to the improvement of wound healing and, relaxation, in particular, seems 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 on chronic wounds such as DFU. This is a Pilot Randomised Controlled Study of a Psychological Intervention that aims to evaluate the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - EG) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), to inform a future definitive Randomised Controlled Study (RCT) that tests its effectiveness. This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the care system of multidisciplinary diabetic foot consultations. Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic ulcers active at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the three conditions - EG, 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 with patients with DFU that benefited from the relaxation sessions and to the health professionals 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.

Detailed description

General Aims: This pilot RCT aims to assess the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - GE) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), prior to the implementation of a future definitive RCT that will assess its effectiveness. This study will also examine, qualitatively, the perspectives of patients with DFU regarding the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the multidisciplinary team of diabetic foot consultations. Pilot RCT specific aims: 1. To evaluate the rates of eligibility, recruitment and adherence to the study protocol, participation in follow-up, and withdrawal. The degree of patient satisfaction with the relaxation intervention will also be assessed. 2. To verify the feasibility of the assessment protocol and to obtain preliminary estimates of the effects of the intervention on health outcome measures (degree of DFU healing, DFU-related quality of life, anxiety, depression and stress, DFU representations and physical and mental quality of life); 3. Synthesize the information to estimate the sample size required for a future definitive RCT. Qualitative study nested in Pilot RCT specific aims: 4. To understand the perspective of patients and health professionals about the relaxation sessions; 5. To explore the contribution of the relaxation sessions to the DFU healing and patients' quality of life; 6. To describe the changes perceived in the patient during the period of relaxation sessions; 7. To analyse the relevance of implementing relaxation sessions in the multidisciplinary team consultation of diabetic foot. Data Analysis: To assess the feasibility of this pilot study (aim 1), the rates of eligibility, recruitment and adherence to the study protocol, participation in the follow-up and withdrawal will be calculated and its results will be presented in percentage. The results of the degree of satisfaction with the intervention will be presented through mean and standard deviation. To obtain preliminary estimates of the intervention effects' on health outcome measures (aim 2), descriptive measures of the respective variables (means and standard deviations) will be calculated and Generalised Mixed Models will be used to check for statistically significant differences over time, in the different groups. Data will be analysed using IBM SPSS Statistics 26 for Mac. Finally, from the data obtained, the sample size for a future definitive RCT will be calculated (aim 3). To answer the aims 4 to 7, a semi-structured interview guide consisting of open-ended questions will be administered to patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care. This script will remain unchanged throughout the interviews. The audio recording of the interviews will be done using a tablet, transcribed verbatim and anonymised in order to safeguard participants and data confidentiality. The transcripts of the interviews will be analysed in the same order as conducted, using the thematic content analysis technique (Bardin, 2016). Sample size calculation: The sample size calculation for a pilot RCT, considering the average effect size of 0.5, a statistical power of 80% and a significance level of 5%, revealed that 12 participants were needed in each of the groups (Cocks \& Torgerson, 2013). This approach considers that a one-sided 80% confidence interval for the effect size will exclude the minimum clinically significant difference if the null hypothesis is true (Brown \& Lilford, 2006). Procedure: The doctor or nurse, in the medical appointment, identifies patients that meet the medical inclusion criteria. Patients are invited to participate in the study by the Researcher at the end of the medical appointment and are informed about the aims of the study and the voluntary nature of participation through informed and informative consent. If patients agree to participate, they will sign the consent form. Nurses will then complete RESVECH 2.0 at the end of the appointment and doctors will complete the clinical questionnaire. Afterwards, the Researcher will accompany the patient to a room provided by the Hospital in order to administer the battery of questionnaires in the interview format. After answering the questionnaires, the researcher will score the PSS and HADS instruments to identify the presence of significant clinical levels of stress, anxiety and depression, and if the patient is eligible, at the end of that week, the participant will be randomized into one of three possible groups. In the next diabetic foot appointment, the respective participant will be informed about the group to which he or she has been allocated and whether will benefit, if appropriate, from four sessions of relaxation (EG) or neutral guided imagery (ACG), depending on the group. If the participant is available, the first session will take place on the same day. The following sessions will be scheduled according to the medical diabetic foot consultations. In each session, two assessments of blood pressure and heart rate will be performed, before starting the session and at the end of the session. At the end of the fourth session, the T1 assessment will be performed, with a new administration of the questionnaires. Six months after T0, the T2 (follow-up) evaluation will take place, with the last administration of the questionnaires. The interviews with patients, who completed the four sessions of relaxation, and with health professionals, will be conducted two weeks after T1, by a different researcher than the one involved in the intervention, to reduce the bias of social desirability.

Conditions

• Diabetes Mellitus
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
BEHAVIORAL	Muscle Relaxation with Guided Imagery	Relaxation intervention session begins with diaphragmatic breathing, followed by Jacobson's progressive muscle relaxation, which involves the contraction and subsequent relaxation of the 16 muscle groups of the body (forearm, arm, upper forehead, eye, mouth, jaw and throat, neck, shoulder, chest, stomach, thigh, leg and foot). The contraction is performed for 7 seconds while the relaxation lasts for about 40 to 50 seconds. The relaxation of the foot muscle group is only performed on the healthy foot, because dressing and bandages may bandage the foot with the DFU, which together with the typical joint stiffness of the diabetic foot, make it difficult to perform. After muscle relaxation, begins the guided imagery focused on DFU healing. The patient is instructed to think about his/her current state of health and to imagine the DFU as a dark area and the healing relaxation as a light associated to pleasant sensations, which will focus on the foot with DFU to heal it.
BEHAVIORAL	Neutral Guided Imagery	This placebo consists on neutral guided imagery focused on themes of the patient's daily life before having DFU. Each session has a theme associated with the patient's life - family, work, friends and leisure. Initially, the patient is asked to think about an event related to the theme of the session of his/her choice, be it positive or negative, which occurred before patient has the current DFU. Then, questions are asked which allow a more detailed reconstruction of the event and the patient is asked to imagine according only to the instructions given. When the whole episode is remembered, the patient is asked to tell what he or she imagined/remembered in each of the questions given.

Timeline

• Start date: 2019-03-19
• Primary completion: 2021-09-30
• Completion: 2021-11-30
• First posted: 2020-12-04
• Last updated: 2022-05-19

Locations

2 sites across 1 country: Portugal