Childhood Immunization: Reducing Immunization Distress (RID) Using Multi-Modal Distraction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Child pain intensity
研究概览
简要总结
The purpose of this study is to compare the effectiveness of a more feasible method for reducing the pain and distress of childhood immunization with the standard method in use at the Pediatric Medical Group. A secondary aim is to evaluate the impact of parental involvement on the parent and child satisfaction with the immunization experience.
Study Hypotheses: In the standard, pre-kindergarten, two- or three vaccine sequence, there will be no statistically significant group differences between PPT and ST with respect to:
- Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary outcome);
- Parent report of child pain using the FPS-R;
- Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale14;
- Parent and child satisfaction with pain management during immunization measured by a 5-point Likert type scales;
- Time required for completion of immunization from initiation of ST or PPT to 2 minutes after completion of the last injection.
详细描述
Berberich and Landman conducted a randomized clinical trial demonstrating efficacy of a multimodal distraction technique to reduce immunization distress (RID) in 4-6 year old children receiving pre-kindergarten immunizations. Widespread implementation would require fewer steps and a reduction of personnel and the current study addresses the practical time and personnel limitations of the method. The current RID trial proposes a randomized design to compare our current method, the standard technique, (ST), with its minimally altered approach where arm gripping and rubbing adjacent to the injection site are to be performed by the medical assistant conducting the injection, substituting for the non-commercially available 'arm gripper'. Pressure and rubbing stimuli at injection sites are documented to be equally effective. The ST will be compared against the parental participation technique, (PPT), whereby the parent participates in the delivery of pain-relieving interventions in lieu of the second medical assistant. The primary aim of the present proposal is to compare the effectiveness of the more feasible PPT to the ST in reducing the pain and distress of childhood immunization. A secondary aim is to evaluate the impact of parental involvement on the parent and child satisfaction with the immunization experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children, ages 4-6 years, scheduled to receive the standard pre-kindergarten immunizations. This consists of two injections: the Dtap (diphtheria, tetanus, acellular pertussis) and IPV (injectable polio vaccine) or three injections: DTAP, IPV and MMR (measles, mumps, rubella);
- •With or without prior exposure to ST at PMG;
- •English speaking subject and parents
排除标准
- •Acute concurrent illness;
- •Invasive procedures such as cannulation, venipuncture or urinary VCG in the preceding 6 months;
- •Hospitalization or ED visit, within the prior 6 months;
- •Chronic medical conditions requiring repeated painful interventions;
- •Inability to respond age appropriately with verbal and written answers to questions, to pain scale measures, or to questionnaires;
- •Refusal to be videotaped.
结局指标
主要结局
Child pain intensity
时间窗: 2 minutes after completion of the immunization series.
Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale (primary outcome); Parent report of child pain using the FPS-R.
次要结局
- Time for completion of immunization(From the start of the procedure to 2 minutes after completion of the immunization series.)
- Child and parent satisfaction with procedure(2 minutes after completion of the immunization series.)
- Child pain intensity(Immediately before, and after injection in each arm.)
研究者
Linda Franck
Professor
University of California, San Francisco