NCT Number: NCT05689944
Pain, when it becomes chronic, can be a threat to patients and it is very common to observe a fear of pain and a fear of movement (kinesiophobia). Avoidance of movement due to fear of pain can lead to a deterioration of body image. Non-medicinal therapies are essential to correct this fear and movement avoidance behavior, to decrease "catastrophic" judgments and thus anxiety. The use of art-therapy in the accompaniment of patients with pain has shown, in particular, decreases in the intensity of pain, the level of anxiety, an improvement in stress, mood and overall psychological state. However, according to the current literature, it appears that 1) this technique is rarely used in children or adolescents, for whom non-medicinal therapies are fundamental, and 2) in the case of chronic pain, the form of art used is very rarely related to the body (most often painting, drawing, music...).
In this project, investigators propose to set up and test the potential benefit of art-therapy sessions related to the body, namely dance-therapy, in adolescents and young adults suffering from chronic pain.
Interested in participating?
Request Info12 year–20 year
All sexes
Interventional
Not applicable
Bron, 69677, France
Location status: Recruiting
Caroline PERCHET, research engineer
CONTACT
04 72 35 78 88 ext. +33
Maud FROT, INSERM Researcher
CONTACT
04 72 35 78 88 ext. +33
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This session will take place once a week between weeks 1 and 15 of the protocol.
After the session, the patient will be asked to think about the next session if he/she wishes (e.g. think of a choreography, remember what was done etc. ....) in order to encourage the commitment to care. These sessions will be based on contemporary dance and dance improvisation techniques.
This session will take place once a week between weeks 1 and 15 of the protocol.
After the session, the patient will be asked to think about the next session (e.g. collecting plants for collage....) in order to encourage commitment to the treatment. The sessions will be based on acrylic painting or collage techniques.
This session will take place once a week between weeks 1 and 15 of the protocol.
These sessions engage the body without entering into a therapy protocol turned towards art as in the two previous interventions.
Time frame: Weeks 0, 5, 16, 20 and 28.
Daily self-assessment on visual numerical scale of pain intensity upon awakening, at bedtime, and on average during the day. Each item is scored 0-10 (0= no pain; 10 = maximal pain). Reporting of the times during the day and night when the patient feels pain and its intensity.
Time frame: Inclusion, weeks 5, 16, 20, 28.
Evaluation of the kinesiophobia index with the TAMPA scale: 13 items to be evaluated on a 4-point Likert-type scale between 1 (strongly disagree) and 4 (strongly agree). Scores between 13 and 52, a score of 30/52 being considered as a significant kinesiophobia.
Time frame: Inclusion, weeks 5, 16, 20, 28
Screen for Child Anxiety Related Disorders (SCARED). 41 items to be evaluated on a 3-point Likert-type scale between 0 ('not true' or 'almost never true') and 2 ('very true' or 'often true'). A score greater than or equal to 25 may indicate the presence of an anxiety disorder.
Time frame: Inclusion, weeks 5, 16, 20, 28
For adult patients: HAD scale. 14 items rated from 0 to 3. Seven items relate to anxiety and seven others to the depressive dimension. The highest scores correspond to the presence of a more severe symptomatology.
Time frame: Inclusion, weeks 5, 16, 20, 28.
Pain catastrophizing scale (PCS). 13 items to be evaluated on a 5-point Likert-type scale between 0 (never) to 4 (always). Scores between 0 and 52. A total PCS score of 30 represents clinically relevant level of catastrophizing.
Time frame: Inclusion, weeks 5, 16, 20, 28.
Fear of Pain Questionnaire (FOPQ). 24 items to be evaluated on a 5-point Likert-type scale between 0 (Strongly disagree) and 4 (Strongly agree). Scores between 24 and 96. A total score between 51 and 96 represents a high fear of pain
Time frame: Inclusion, weeks 5, 16, 20, 28.
For adults patients: FABQ questionnaire. 16 items evaluated on a 7-point Likert scale between 0 (strongly disagree) and 4 (strongly agree). The first 5 items test fear and beliefs about pain in relation to physical activity and the second part of the questionnaire (12 items) tests fear and beliefs about pain in relation to work.
Time frame: Inclusion, weeks 5, 16, 20, 28.
-VSP-A scale for adolescents. 40 items to be evaluated on a 5-point Likert-type scale between 0 (always) and 100 (never). This scale explores 6 areas (psychological well-being, energy/vitality, leisure activities, friendships, relationships with parents, school life). The scores are averaged and then transformed to obtain a rating between 0% and 100%. A total score below 50% is considered to reflect a low quality of life.
Time frame: Inclusion, weeks 5, 16, 20, 28.
-The McGill Quality of Life Questionnaire-revised version (MQOL-R) for the adults. 14 items to be evaluated on a 11-point Likert-type scale between 0 (not at all) and 10 (extremely). These items form 4 subscales (physical, psychological, existential, and social). The total MQOL-R score is the average of the scores on the 4 subscales.
Time frame: Inclusion, weeks 5, 16, 20, 28.
QSCPGS questionnaire. 20 items. The QSCPGS is divided into two parts. Each part consists of a series of 10 items. The first set is designed to define how the individual perceives his or her body and the second seeks to highlight the feelings of himself in a more global way. Each item is composed of a positive term (good health, pure, calm. . .) and its opposite (bad health, impure, nervous. . .); these two expressions are opposed by a series of numbers from 1 to 5 presented in mirror and separated in their center by the 0; the 1 corresponds to the answer "very little" and 5: "very strong".
Time frame: Weeks 0, 5, 16, 20 and 28.
Daily measurement of sleep quality, wake quality and average day energy (5-point Likert-type scale between 'very good' and 'very bad'). Filling out a sleep diary with the daily bedtime and wake-up times for one week.
Contact information is provided by the study sponsor or research team.
Caroline PERCHET, research engineer
CONTACT
04 72 35 78 88 ext. +33
Maud FROT, INSERM Researcher
CONTACT
04 72 35 78 88 ext. +33
Hospices Civils de Lyon
Other
Effect of Dance-therapy on Chronic Adolescent Pain Patients - a Randomized Controlled Trial Study
Acronym: ALGODANCE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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