Relaxation Intervention in Patients With Diabetic Foot Ulcer

NACompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

March 19, 2019

Primary Completion Date

September 30, 2021

Study Completion Date

November 30, 2021

Conditions
Diabetes MellitusDiabetic Foot Ulcer
Interventions
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.

Trial Locations (2)

4564-007

Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa, Penafiel

4099-001

Centro Hospitalar Universitário do Porto, Porto

All Listed Sponsors
collaborator

Foundation for Science and Technology, Portugal

OTHER

lead

University of Minho

OTHER

NCT04652999 - Relaxation Intervention in Patients With Diabetic Foot Ulcer | Biotech Hunter | Biotech Hunter