Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer

NACompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

February 1, 2019

Primary Completion Date

December 31, 2021

Study Completion Date

July 25, 2022

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

Hypnosis with Guided Imagery

"In the beginning of the first session we apply the Eye-Roll Test for Hypnotizability of Herbert Spiegel. Each session follows the Hypnotic Protocol with the following steps:Pre-talk/Absortion/Ratification/Aliciation/Dissociation/Awakening.~The four sessions train the participants in visual, auditory and kinesthetic perception on ulcer healing. The protocol also promotes medical treatment acceptance."

BEHAVIORAL

Neutral Guided Imagery

This placebo consists of 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, positive or negative, which occurred before patient has the current DFU. Then, the patient is asked about a number of questions regarding the chosen episode in order to promote a more detailed reconstruction of the event. The patient is asked to imagine according to the instructions given by the Psychologist. When the whole episode is remembered, the patient is asked to tell what he or she imagined/remembered regarding each of the questions.

Trial Locations (3)

4710-243

Hospital de Braga, Braga

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

NCT04698720 - Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer | Biotech Hunter | Biotech Hunter