Effectiveness of Integrated Education and Relaxation Program on Migraine Related Disability in Patients Attending Headache Clinic, Ain Shams University Hospitals: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Effectiveness of the intervention program on headache frequency
研究概览
简要总结
Migraine causes severe impairment in quality of life (QOL) both during and between attacks. Migraine also increases absenteeism, reduces productivity at work as well as at home, disrupts social and family relationships, also is associated with increased healthcare costs.
The current study aiming to evaluate the effectiveness of an integrated therapeutic patient education and relaxation training intervention in order to decrease the burden of migraine headache among adult patients attending the headache clinic in Ain Shams University Hospitals.
详细描述
- The participants will be assessed for their eligibility based on inclusion and exclusion criteria. After obtaining the written informed consent, the eligible participants will be randomized to either an intervention or a control group. Psychiatric and personality disorders will be excluded before participation using the translated form of (Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders) I and II questionnaires.
The participants in the intervention group will receive the education and training program in addition to the routine pharmacological treatment whereas the participants in the control group will receive only the routine pharmacological treatment (preventive treatment with stable dose for at least 3 months and not to change the dose through the study).
For proper conduction of the study, three phases will be performed:
Assessment phase:
Each migraine patient in the intervention and control group will be interviewed individually before applying the planned program to collect socio-demographic data and clinical migraine evaluation using the clinical sheet of the clinic. Then base line measures of headache-related disability and migraine specific quality of life using migraine specific quality of life questionnaire before any intervention. Retrospective recording of 1 month past migraine attacks frequency will be recorded. This interview will take about 25-30 minutes.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years old.
- •Diagnosed with migraine for at least 6 months duration.
- •Experiencing 4 or more migraine days/month with disability.
- •Willingness to practice relaxation exercises at home.
排除标准
- •Secondary headache.
- •Patients with severe co-morbid psychiatric (depression, anxiety), personality or medical condition (liver or renal impairments).
结局指标
主要结局
Effectiveness of the intervention program on headache frequency
时间窗: 3 month
Attacks frequency, expressed in days per month , will be collected from the "headache diary" filled in by the patient. Data will be recruited from the diary at base line and after another 4 weeks, Final evaluation will be done after 3 month
Effectiveness of the intervention program on headache intensity
时间窗: 3 month
The average of monthly attacks intensity ( severity) will be measured using the (Numerical rating scale) (from 0 to 10 scales) included in the headache diary Data will be recruited from the diary at base line and after 4 weeks, Final evaluation will be done after 3 month from beginning of the intervention program
Effectiveness of the intervention program on headache (attacks) duration
时间窗: 3 month
The average of monthly attacks duration will be calculated from the headache diary filled in by the patient at base line,4 weeks and finally after 3 month from the baseline evaluation
次要结局
- Effectiveness of the intervention program on headache related quality of life and disability(3 month)