Relaxation Intervention in Patients With Diabetic Foot Ulcer
NCT ID: NCT04652999
Last Updated: 2022-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
54 participants
INTERVENTIONAL
2019-03-19
2021-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer
NCT04698720
Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers
NCT05110092
Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers
NCT06487780
Analysis of the Effects of LED Phototherapy and Electrical Stimulation in the Healing of Diabetic Ulcers
NCT03250533
Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers
NCT04246814
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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).
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Muscle Relaxation with Guided Imagery
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.
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.
Active Control Group
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.
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.
Passive Control Group
The participants in the Passive Control Group will not receive any intervention nor placebo session.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Foundation for Science and Technology, Portugal
OTHER
University of Minho
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gabriela Ferreira
Master in Health Psychology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gabriela Ferreira, Master
Role: PRINCIPAL_INVESTIGATOR
School of Psychology, University of Minho
M.Graça Pereira, PhD
Role: STUDY_DIRECTOR
School of Psychology, University of Minho
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa
Penafiel, , Portugal
Centro Hospitalar Universitário do Porto
Porto, , Portugal
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90. doi: 10.2165/00019053-200321170-00004.
Bardin L. Análise de Conteúdo [Content Analysis]. 2016; São Paulo, Brasil: Almedina. Brasil.
Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.
Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197-201. doi: 10.1016/j.jclinepi.2012.09.002. Epub 2012 Nov 27.
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
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
Ferreira P. A medição do estado de saúde: Criação da versão portuguesa do MOS SF-36 [Measuring health status: Creation of the Portuguese version of MOS SF-36]. Coimbra: Centro de Estudos e Investigação em Saúde, Faculdade de Economia, Universidade de Coimbra; 1998.
Ferreira PL, Ferreira LN, Pereira LN. Medidas sumário física e mental de estado de saúde para a população portuguesa [Physical and mental summary measures of health state for the Portuguese population]. Revista Portuguesa de Saúde Pública. 2012;30(2):163-171. doi:10.1016/j.rpsp.2012.12.007.
Ferreira V, Martins J, Loureiro L, Loureiro T, Borges L, Silveira D, … Almeida R. Consulta multidisciplinar do pé diabético: Avaliação dos fatores de mau prognóstico [Multidisciplinary consultation of diabetic foot - factors related with bad prognosis]. Angiologia e Cirurgia Vascular. 2014;10:146-150. doi:10.1016/j.ancv.2014.08.005
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.
Grant S, Mayo-Wilson E, Montgomery P, Macdonald G, Michie S, Hopewell S, Moher D; , on behalf of the CONSORT-SPI Group. CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials. Trials. 2018 Jul 31;19(1):406. doi: 10.1186/s13063-018-2735-z.
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
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.
Pais-Ribeiro J, Silva I, Ferreira T, Martins A, Meneses R, Baltar M. Validation study of a Portuguese version of the Hospital Anxiety and Depression Scale. Psychol Health Med. 2007 Mar;12(2):225-35; quiz 235-7. doi: 10.1080/13548500500524088. English, Portuguese.
Paiva D, Silva S, Severo M, Ferreira P, Santos O, Lunet N, Azevedo A. Cross-cultural adaptation and validation of the health literacy assessment tool METER in the Portuguese adult population. Patient Educ Couns. 2014 Nov;97(2):269-75. doi: 10.1016/j.pec.2014.07.024. Epub 2014 Jul 22.
Pandis N. Randomization. Part 3: allocation concealment and randomization implementation. Am J Orthod Dentofacial Orthop. 2012 Jan;141(1):126-8. doi: 10.1016/j.ajodo.2011.09.003. No abstract available.
Trigo M, Canudo N, Branco F, Silva D. Estudo das propriedades psicométricas da Perceived Stress Scale (PSS) na população Portuguesa [Psychometric proprieties of the Perceived Stress Scale (PSS) in Portuguese population]. Psychologica. 2010;53:353-378. doi:10.14195/1647-8606_53_17
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEICVS015/2019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.