Effect of Dance-therapy on Chronic Adolescent Pain Patients - a Randomized Controlled Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Assesment of pain change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 12 to 20 years, girls or boys, with chronic pain.
- •Diagnosis of chronic pain made in a Pain Management Center
- •Patients followed in a Pain Management Center (to ensure that patients entering the protocol have pain that is not relieved by conventional treatments)
- •Patients who have given written consent for adults or whose parents have given consent for minors
- •Patients who are affiliated with or benefit from a social security system.
排除标准
- •Patients with other neurological or psychological disorders
- •Patients with psychiatric illnesses
- •Patients with chronic infectious, metabolic, cancerous, autoimmune diseases.
- •Non-communicating patients including deaf and hard of hearing patients
- •Patients or parents who do not speak or read French
- •Pregnant women
- •Dance or yoga professionals (dance or yoga teachers or those studying to become teachers)
研究组 & 干预措施
Dance-therapy group
Patients in the dance-therapy group will attend a weekly session of dance-therapy between weeks 1 and 15 of the protocol (15 sessions). They will be asked to complete daily pain and sleep diaries at weeks W0, W5, W16, W20 and W28 as well as questionnaires (kinesiophobia, anxiety, catastrophizing, fear of pain, quality of life, body image/self-perception). They will also be asked to assess their pain, fatigue and mood levels at the end of each week between W1 and W15.
干预措施: Dance-therapy (Behavioral)
Art-therapy group
Patients in the art-therapy group will attend a weekly session of art-therapy (drawings, collages…) between weeks 1 and 15 of the protocol (15 sessions). They will be asked to complete daily pain and sleep diaries at weeks W0, W5, W16, W20 and W28 as well as questionnaires (kinesiophobia, anxiety, catastrophizing, fear of pain, quality of life, body image/self-perception). They will also be asked to assess their pain, fatigue and mood levels at the end of each week between W1 and W15.
干预措施: Art-therapy (Behavioral)
Yoga group
Patients in the yoga group will attend a weekly session of Vinyasa yoga between weeks 1 and 15 of the protocol (15 sessions). They will be asked to complete daily pain and sleep diaries at weeks W0, W5, W16, W20 and W28 as well as questionnaires (kinesiophobia, anxiety, catastrophizing, fear of pain, quality of life, body image/self-perception). They will also be asked to assess their pain, fatigue and mood levels at the end of each week between W1 and W15.
干预措施: Yoga (Behavioral)
Control group
Patients in the control group will not participate in any art-therapy or yoga interventions. They will be asked to complete pain and sleep diaries, questionnaires and pain, fatigue and mood scales at the same times and for the same duration as the other groups.
结局指标
主要结局
Assesment of pain change
时间窗: 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.
次要结局
- Kinesiophobia(Inclusion, weeks 5, 16, 20, 28.)
- Anxiety (adolescents)(Inclusion, weeks 5, 16, 20, 28)
- Anxiety (adults)(Inclusion, weeks 5, 16, 20, 28)
- Pain catastrophizing(Inclusion, weeks 5, 16, 20, 28.)
- Fear of Pain (adolescents)(Inclusion, weeks 5, 16, 20, 28.)
- Fear of Pain (adults)(Inclusion, weeks 5, 16, 20, 28.)
- Incidence of art therapy on quality of life (adolescents)(Inclusion, weeks 5, 16, 20, 28.)
- Incidence of art therapy on quality of life (adults)(Inclusion, weeks 5, 16, 20, 28.)
- Body satisfaction and global self-perception(Inclusion, weeks 5, 16, 20, 28.)
- Incidence of art therapy on sleep quality(Weeks 0, 5, 16, 20 and 28.)