Management of Chronic Non-Cancer Pain With Non-Pharmacological Therapies: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Well-being
研究概览
简要总结
A randomized controlled clinical trial will be conducted, involving a psychoeducational activity as the intervention. There will be a control group of patients with non-cancer chronic pain who will continue their usual treatment.
The trial will end after 3 months. Pain, well-being, medication management, mood, self-esteem, and quality of life will be compared just before starting the workshop with the status at the end of the workshop (one month later) to assess the immediate effect, and three months later to evaluate the medium-term effect. These measurements will be taken in both the control and intervention groups.
Additionally, for the intervention group, a follow-up will be conducted six months after the workshop ends to assess the long-term effect duration.
This study does not allow blinding of patients or professionals conducting the intervention, but the person analyzing the data to compare the effect produced in the control and intervention groups will be blinded. Therefore, it is an observer-blind evaluation.
详细描述
Intervention Group: Workshop. This group starts and completes the workshop (attend at least 4 out of the 5 sessions). Complete all the initial documentation, at the end of the workshop, and at the 3-month mark. Perform daily tracking of the 3 mandatory activities throughout the duration of the workshop.
Control Group: Traditional treatment. This group meets the inclusion criteria but does not participate in the workshop. They complete all documentation at the beginning, at one month, and at three months. These patients will continue with the usual treatment prescribed by their doctor.
Intervention: Chronic Pain Management Workshop with Non-Pharmacological Therapies. Psychoeducational and self-care training, pain management, and emotional control, conducted in groups and aimed at patients with non-cancer chronic pain.
Workshop Methodology and Facilities: It will take place at HSJDA over 5 afternoons, with each session lasting 3.5 hours. Sessions will be held once a week for 5 consecutive weeks.
The sessions will include oral presentations supported by PowerPoint, videos, activities to be performed in the classroom by the patients to apply different techniques, testimonies from individuals known for personal overcoming, experiences from patients of previous workshops, and the application of the explained tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The statistician who analyse the data is unaware of the group to which each patient belonged.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 years or older,
- •Residing in the areas served by HSJDA,
- •With non-cancer chronic pain already diagnosed and treated for at least 6 months but not relieved by the usual treatment,
- •Who have explicitly and in writing expressed their desire to participate in the workshops and the study through the Informed Consent document,
- •And who complete the initial documentation necessary for their evaluation.
排除标准
- •Patients in the diagnostic phase,
- •Patients with pain exclusively associated with cancer pathology,
- •Patients with a life expectancy of less than one year,
- •Patients with severe cognitive or mental illnesses that prevent them from understanding both the content of the workshops and the measurement instruments.
结局指标
主要结局
Well-being
时间窗: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).
Numerical visual scale from 0 (minimum) to 10 (maximum). Higher scores indicate greater well-being.
Pain last week
时间窗: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).
Pain measured with the "visual analogue scale" (scale: 0-10)
Analgesic regimen
时间窗: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).
self-assessment at the end of the workshop on whether they have replaced a higher-tier analgesic with a lower one, decreased the dosage, reduced the frequency, or stopped taking analgesics or anxiolytics/antidepressants.
Anxiety and Depression
时间窗: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).
Hospital Anxiety and Depression Scale (HADS). It consists of 14 items with two subscales (anxiety and depression), each with scores from 0 to 3. Cut-off points: \<8 normal, 8-10 possible cases, and \>10 for cases in both subscales.
Resilience
时间窗: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).
Brief Resilience Scale (BRS). Scale from 6 (minimum) to 30 (maximum). Higher scores indicate greater resilience.
Self-esteem
时间窗: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).
Rosenberg Self-esteem Scale, ranging from 9 (minimum) to 36 (maximum).Higher scores indicate greater Self-esteem
Number of emergency episodes and outpatient visits
时间窗: 3 measurements: The scale will be administered just before starting the workshop, at 3 months, and at 6 months (this only in the intervention group).
The number of emergency episodes and outpatient visits for pain or associated symptoms (anxiety, depression, insomnia) will be quantified, both in primary care (at their health center) and hospitalized.
Health-related quality of life
时间窗: 4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).
Measured with the EuroQol-5D questionnaire. Scale from 0 to 1 (maximum) (with the possibility of negative values). Higher scores indicate greater health-related quality of life.
次要结局
- Satisfaction with the workshop(1 measurement: The scale will be administered just at the end (last day of the workshop, after 4 weeks) (this only in the intervention group).)
- Improving habits(2 measurements: In the 3rd session and just at the end (last day of the workshop, after 4 weeks) (this only in the intervention group).)