Relaxation Intervention in Patients With Diabetic Foot Ulcer

NCT04652999 | Completed

• 1 other identifier: CEICVS015/2019
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus; Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer; Relaxation; Ulcer Healing; Quality of Life; Pilot RCT

Outcome Measures

Primary Outcomes (7)

• Rate of eligibility

  This rate will result from the proportion between the number of eligible patients and the total number of observed patients, in percentage.

  Baseline (T0)

• Rate of recruitment

  This rate will result from the proportion between the number of patients who accepted to participate and the number of eligible patients, in percentage.

  Baseline (T0)

• Rate of refusal

  This rate will result from the proportion between the number of patients who rejected to participate in the study and the number of patients invited to participate, in percentage.

  Baseline (T0)

• Rate of adherence to the study protocol

  This rate will result from the proportion between the number of patients who performed the assessments/intervention sessions and the number of patients who completed the baseline assessment (T0), in percentage.

  Through study completion, an average of 6 months

• Rate of participation in follow-up

  This rate will result from the proportion between the number of patients who participated in follow-up assessment and the number of patients who completed the baseline assessment (T0), presented in percentage.

  Through study completion, an average of 6 months

• Rate of dropout

  This rate will result from the proportion between the number of patients who dropout the study and the number of patients who completed the baseline assessment (T0), presented in percentage.

  Through study completion, an average of 6 months

• Patient satisfaction with the relaxation intervention

  The degree of patients´ satisfaction with the relaxation intervention will be assessed through questions developed for this purpose, including the degree of general satisfaction with the sessions; the impact on stress, anxiety and depression, and wound healing after the four sessions; the degree of usefulness for patients with DFU; the desire to participate in future sessions; and the recommendation of the sessions to other patients with DFU. All the questions will be assessed on a Likert scale from 1 (very unsatisfied/ none/ totally disagree) to 5 (very satisfied/ extreme/ totally agree).

  End of intervention/ 2 months later at post-test (T1)

Secondary Outcomes (13)

• Degree of DFU healing

  Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)

• Impact of DFU on patients' Quality of Life

  Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)

• Physical Quality of Life

  Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)

• Mental Quality of Life

  Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)

• Perceived Stress

  Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)

Other Outcomes (3)

• Sociodemographic Data

  Baseline (T0)

• Health Literacy

  Baseline (T0)

• Clinical Data

  Baseline (T0), end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)

Study Arms (3)

Muscle Relaxation with Guided Imagery

EXPERIMENTAL

The participants in Experimental Group will receive four individual 45-minute sessions, every two weeks, of progressive muscle relaxation intervention with guided imagery focused on ulcer healing, carried out by the Psychologist responsible for implementing the project, on the day of the Diabetic Foot appointments.

Behavioral: Muscle Relaxation with Guided Imagery

Active Control Group

PLACEBO COMPARATOR

Participants in the Active Control Group will receive four individual 45-minute sessions of neutral guided imagery placebo, carried out by the Psychologist responsible for implementing the project, on the day of the Diabetic Foot appointments.

Behavioral: Neutral Guided Imagery

Passive Control Group

NO INTERVENTION

The participants in the Passive Control Group will not receive any intervention nor placebo session.

Interventions

Muscle Relaxation with Guided Imagery BEHAVIORAL

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.

Muscle Relaxation with Guided Imagery

Neutral Guided Imagery BEHAVIORAL

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.

Active Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes Mellitus diagnosis;
• Diagnosis of Diabetic Foot;
• Having one or two active chronic ulcers (\> 6 weeks) at the time of the 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 Hospital de Braga;
• Presenting clinical levels of stress (scores greater than 13 for males and greater than 17 for females on the Perceived Stress Scale) or anxiety or depression (scores greater than 11 on Hospital Anxiety and Depression Scale).

You may not qualify if:

• The active DFU at the time of the assessment being a relapse;
• Having more than two DFU currently active;
• 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.
• Three typical cases of 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;
• Three typical cases of 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.

Sponsors & Collaborators

• University of Minho: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (2)

Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa

Penafiel, 4564-007, Portugal

Location

Centro Hospitalar Universitário do Porto

Porto, 4099-001, Portugal

Location

Related Publications (18)

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• Direção-Geral de Saúde, DGS [General Health Direction, Portugal] Circular Normativa Nº:05/PNPCD: Pé Diabético, Programa Nacional de Prevenção e Controlo da Diabetes (PNPCD) [Normative Circular Nº: 05 / PNPCD: Diabetic Foot, National Diabetes Prevention and Control Program]; 2010. Retrieved from http://www.dgs.pt/?cr=15718

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• Figueiras M, Marcelino DS, Claudino A, Cortes MA, Maroco J, Weinman J. Patients' illness schemata of hypertension: the role of beliefs for the choice of treatment. Psychol Health. 2010 Apr;25(4):507-17. doi: 10.1080/08870440802578961.

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  PMID: 30060763 BACKGROUND

• International Working Group on the Diabetic Foot [IWGDF] International Consensus on the Diabetic Foot. International Diabetes Foundation; 2015. Retrieved from http://www.iwgdf.org/files/2015/website_prevention.pdf

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• Marques JM. Adaptação cultural e validação para a população portuguesa de um instrumento de monitorização de feridas crónicas - escala RESVECH 2.0 [Cultural adaptation and validation for the Portuguese population of a chronic wound monitoring instrument - RESVECH 2.0 scale] (Master's Thesis). Instituto de Ciências da Saúde da Universidade Católica, Porto; 2015.

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  BACKGROUND

• Ferreira G, Bernardo AC, Carvalho A, Pereira MG. Relax to Heal? Perspectives of Patients with Diabetic Foot Ulcers and Health Professionals on Relaxation Sessions for Wound Healing. Adv Skin Wound Care. 2023 Jun 1;36(6):1-10. doi: 10.1097/01.ASW.0000922832.62539.a3. Epub 2023 Apr 4.

  PMID: 37017401 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Interventions

Muscle Relaxation; Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Muscle Contraction; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gabriela Ferreira, Master

  School of Psychology, University of Minho

  PRINCIPAL INVESTIGATOR

• M.Graça Pereira, PhD

  School of Psychology, University of Minho

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Eligible participants will be randomised into the three groups into blocks of variable size, multiples of three; and will be stratified according to: i) data collection site; ii) Chronic Renal Disease; and iii) Peripheral Arterial Disease; because they 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 a researcher external to the team involved in the implementation of this study, in order to ensure the concealment of the allocation of participants by the various groups (Pandis, 2012). After this procedure, it will not be possible to conceal the group to which the patient belongs from the researcher who will perform the psychological intervention. However, health professionals (doctors and nurses) will be blinded during the entire procedure, because they fill in the RESVECH 2.0, which assesses the DFU healing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Health Psychology

Model Details: This is a Pilot Randomised Controlled Study of a Psychological Intervention (Eldridge et al., 2016; Grant et al., 2018). This study will use a mixed-methods approach nested in a pilot 3-arm randomized control design. Qualitative and quantitative data will be collected in order to provide better understanding about the feasibility and acceptability of the relaxation intervention in patients with DFU. Participants will be randomised at a ratio of 1:1 for the three conditions - EG, ACG and PCG; and will be evaluated on the day of the first chronic DFU appointment or nursing treatment (T0), two months later (at the end of the intervention in EG and ACG; T1), as well as six months later (T2) in a follow-up evaluation. Participants from all three groups will undergo standard treatment for the DFU, according to the guidelines of the Portuguese General Health Direction (DGS, 2010) and the International Working Group on the Diabetic Foot (IWGDF, 2015).

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: December 4, 2020
• Study Start: March 19, 2019
• Primary Completion: September 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)