Subject: A Blinded Randomized Trial: the Effect of Guided Imagery in Children With Type 1 Diabetes Mellitus on Glucose Levels and on Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Blood glucose values before and after listening to the recording.
研究概览
简要总结
Background: Pediatric patients with type 1 diabetes mellitus are known to be a challenging group for achieving recommended glycemic control. Coping with the demands of self-managing IDDM in children and adolescents can be a formidable task, requiring a healthy and balanced diet, monitoring and regular insulin injections. Most patients are non-compliant to the treatment. A number of controlled studies have examined the efficiency of psychosocial interventions for improving compliance and glycemic control among diabetic youth. None has examined the effectiveness of guided imagery in treatment of type 1 diabetes mellitus.
Primary Objective: To asses simultaneously the effect of listening to auditory guided imagery and blood glucose variability, compared to variability in blood glucose while listening to songs.
Secondary Objective To assess the effect of routine auditory guided imagery to glycemic control and quality of life in children with type 1 diabetes mellitus, compared to listening listening to songs.
Methods:
Subjects: 14 youth ages 7-16 years with type 1 diabetes mellitus , for at least 6 months, and not during the honey moon period will be recruited, and will be blindly randomized to receive intervention (auditory guided imagery group) or control (regular auditory music).
Protocol:
Design: A randomized Controlled Blinded Study Intervention: 14 randomly numbered CD's will be prepared at study initiation, half containing auditory guided imagery and half containing music.
Study protocol: After an initial check up, including HbA1C levels, and explanation of study procedures the participants will be given either the intervention or the control CD, to be used twice a day for five days. During this period continuous glucose monitoring will be performed. On days one and five the procedure will take place while the participants are connected to biofeedback. QOL questionnaires will be completed at the beginning of day one, or before.
In the second part of the study the children will use the intervention / control CD at home twice a week for 12 weeks. At the end of the study period they will again be evaluated, including HbA1C, and all subjects will again complete QOL questionnaires
详细描述
14 participants will be assigned research numbers in a consecutive recruitment order.(01-14).
14 auditory disks will be prepared ahead of study initiation, 7 with the guided imagery program and 7 with regular songs.
All will look similar from the outside. The disks will be numbered 01-14. Disks numbering will be performed by an investigator who is not part of treatment team, without knowing which disk contains which content. So that the team and participants are blinded to the disk content at initiation.
Children and parents will be aware of the type of auditory disk after initial auscultation at visit number 1.
The team will continue to be blinded to type of disk until end of study. 3. All participants will be aware at study initiation that they may receive the auditory guided imagery disk or a regular songs / story auditory disk.
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)
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus for longer than 6 months
- •Insulin requirements of more than 0.4 units/kg/day for at least 3 months
- •Age 7-16 years
- •Agreement of parents or guardian to participate in the study
- •Agreement and wiliness of child to participate in the study
排除标准
- •Children with cognitive impairment which prevents them from using guided imagery
- •Unable to understand Hebrew
- •Hearing defect
- •Attention deficit disorder
结局指标
主要结局
Blood glucose values before and after listening to the recording.
时间窗: 1 week
Blood glucose variability of teenagers before and after listening to auditory guided imagery, compared to the blood glucose variability of teenagers before and after listening to music. The blood glucose values will be measured by continuous glucose monitoring system (CGMS).
次要结局
- The delta of HA1C between before and after three months of periodic listening to auditory guided imagery, compared to listening to music.(3 months)
研究者
Assaf Harofeh MC
Dr. Marianna Rachmiel
Assaf-Harofeh Medical Center