Body Emotional Map Method for the Reduction of Parental Stress Related to Diabetes: a Randomized Study. BEM-02
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Difference in PSI-SF (Parental Stress Index Short-Form) scores after 3 months
研究概览
简要总结
The purpose of this study is to evaluate the impact of the BEM method on stress and well-being in parents of children/adolescents with type 1 diabetes, compared to a standard group approach focused on therapeutic education (control group). The BEM Program involves an experiential, group-based approach facilitated by 2-3 trained facilitators and a maximum of 25 parent participants. Each session takes place over three consecutive days and includes both plenary sessions with the entire group and smaller subgroup activities. Metodology of BEM approach includes: relaxation techniques, breathing exercises, and guided visualizations NLP (Neuro-Linguistic Programming) techniques: spatial anchoring, Time Line therapy, and future pacing. Approaches based on Transactional Analysis (T.A.) and Systemic-Relational frameworks, brief interventions focused on problem-solving. Techniques for enhancing bodily and emotional awareness. Interactive group discussions. The control intervention will take place during a camp specifically dedicated to parents, with the same duration as the BEM program. The intervention includes educational and informational sessions on key aspects of type 1 diabetes management (management of acute complications, importance of glycemic indices, carbohydrate counting, current and emerging perspectives in type 1 diabetes care). In addition, the program includes opportunities for parents to share personal experiences and participate in recreational activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents of children and adolescents under 18 years of age with type 1 diabetes duration exceeding 12 months;
- •Parents of children who have never been diagnosed with psychiatric or behavioral disorders;
- •Adequate understanding of the Italian language, as assessed by the clinician;
- •Parents willing to: Actively participate in group experiential activities; Complete the required questionnaires; Signed informed consent from the participating individual; Signed informed consent for data processing of the minor by both parents (if applicable).
排除标准
- •with psychiatric conditions
- •of patients with psychiatric issues or behavioral disorders
- •with any problem that, according to the clinician's judgment, would prevent active participation in group experiential activities
结局指标
主要结局
Difference in PSI-SF (Parental Stress Index Short-Form) scores after 3 months
时间窗: From enrollment to 3 months after the participation in the BEM activities
The primary endpoint is represented by the difference in PSI-SF (Parental Stress Index Short-Form) scores after 3 months of participation in the group activities compared to baseline. PSI-SF subscale scores range from 12 to 60, and the total score from 36 to 180. High subscale scores and a high PSI-SF total score indicate higher levels of stress. Responses above the 85th percentile are considered clinically significant.
次要结局
- Difference in PSI-SF (Parental Stress Index Short-Form) scores after 6 months and in the scores of the individual components of the PSI-SF questionnaire(from enrollment to 6 months from participation in the group activities compared to baseline)
- Patient Health Questionnaire (PHQ-9)(From enrollment to 3 and 6 months from participation in the group activities compared to baseline)
- General Anxiety Disorder (GAD-7)(From enrollment to 3 and 6 months from participation in the group activities compared to baseline.)
- Brief Pittsburgh Sleep Quality Index (B-PSQI)(From enrollment to 3 and 6 months from participation in the group activities compared to baseline)
- Parental Self-Efficacy for the Management of Diabetes Mellitus (PSESDM) questionnaire.(From enrollment to 3 and 6 months from participation in the group activities compared to baseline)
- Coping Orientation to the Problems Experienced - Italian Version (COPE-NVI)(From enrollment to 3 and 6 months from participation in the group activities compared to baseline)
- Glucometric data of children/adolescents(From enrollment to 3 and 6 months from participation in the group activities compared to baseline.)
研究者
Valentino Cherubini
Head of Unit, Paediatric Diabetology Department of Women's and Children's Health "G. Salesi Hospital", AOU OORR Ancona, Via F. Corridoni, 11 60123 Ancona, Italy
Ospedali Riuniti Ancona