An Innovative Tailored Intervention for Improving Children's Postoperative Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 659
- 试验地点
- 4
- 主要终点
- Assess children's domains of behavior indicating anxiety [Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents]
研究概览
简要总结
The goal of this randomized trial is to examine the effectiveness of a tailored Internet-based Preparation Program (WebTIPS) in reducing anxiety and improving the recovery process in children undergoing surgery. Two hospitals and all parent-child dyads and healthcare providers (HCPs) will be randomized to either a Web-based Tailored Intervention Preparation for Surgery (WebTIPS) Group or to a Web-based Information (WebINFO) Group, the attention control group. The WebTIPS group will receive the newly developed intervention with short message service (SMS) two-way communication between an HCP and patient, while the WebINFO Group will only receive an internet and mobile platform with information on the management of preoperative anxiety and perioperative pain. The aims of this study are to:
Primary aim:
Quality of Clinical Care:
Determine whether and to what extent WebTIPS is more effective than an attention control intervention in reducing preoperative anxiety among children ages 1-12 years old undergoing anesthesia and outpatient surgery.
Secondary aims:
Quality of Clinical Care:
- Examine the impact of WebTIPS on Post-Anesthesia care unit based postoperative clinical recovery parameters, such as pain and emergence delirium.
- Examine the impact of WebTIPS on home-based postoperative clinical recovery parameters such as pain, new onset behavioral changes and return to normal daily activity over 2 weeks.
- Determine if the use of WebTIPS reduces parental preoperative anxiety.
Experience of Care:
Examine the effects of WebTIPS on parental satisfaction with the overall experience of the surgical episode.
Cost of Care/Resource Use:
Determine if WebTIPS modifies healthcare resource use, as measured by 30-day charges adjusted for Medicaid cost-to-charge ratios.
详细描述
The proposed clustered two-arm single blind, randomized trial of two children's hospitals: CHOC Children's (CHOC) and Seattle Children's Hospital. Approximately 620 patients and their families will be recruited in total. This study will examine the effectiveness of a tailored Internet-based Preparation Program (WebTIPS) aimed at reducing anxiety and improving the recovery process in children undergoing surgery via parent and child interactive preparation modules. Each study site will have a permuted block group assignment stratified by surgical severity. Within each surgical severity group, patients and their families will be randomized to either a Web-based Tailored Intervention Preparation for Surgery (WebTIPS) Group or to a Web-based Information (WebINFO) Group, the attention control group. The WebTIPS group will receive the newly developed interactive intervention with short message service (SMS) two-way communication between a clinician and patient. Conversely, the WebINFO Group will only receive an internet and mobile platform with information on the management of preoperative anxiety and postoperative pain. Objective measures of children's preoperative anxiety and postoperative recovery will be collected prior and during the experimental period.
Patients and their parents in the intervention group will learn through the internet and mobile platforms that implementing strategies and ways to adjust behavior, such as distraction and medical reinterpretation, directs the child's attention away from their own distress or fear. This group will also have access to a SMS messaging system to allow for patient/parent-provider two-way interaction and two-way sharing of information so health care providers learn about parents' coping styles.
Child's anxiety (assessed through the modified Yale Preoperative Anxiety Scale-mYPAS) during induction will be assessed at two points, a) entering the operation room (OR) and b) introduction of the anesthesia mask to the child. If parents accompanied the child into the OR, their anxiety will be rated as they leave the OR (state-trait anxiety inventory-STAI). Also, parents answer baseline questionnaires aimed at capturing demographics (e.g. age, sex), as well as parental coping (through the Miller behavioral style scale), and child temperament (through the emotional, activity, and shyness temperament survey). In the holding area and separation, a research assistant who is blinded to group assignment will rate child anxiety (mYPAS) and ask parent anxiety (STAI), and also assess child/parent anxiety at separation to the OR (mYPAS, STAI). Postoperative analgesic consumption, behavioral and recovery measures will also be collected.
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
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children scheduled to undergo anesthesia and outpatient surgery.
- •Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study.
- •Only children who are in the normal range of development will be recruited for this study
- •Parents of children who are enrolled in the study.
- •Healthcare Providers:
- •Anesthesia care providers in the two study hospitals
- •Nurses who provide preoperative nursing care to children who are about to undergo surgery in the two study hospitals
排除标准
- •Patients with health status defined by ASA status IV-V
- •Children who are not in the normal range of development and who are visually impaired will be excluded from this study.
- •Children with visual impairment.
- •Parents who refuse to be part of the study and whose children are not eligible for the study.
- •Parents who are visually impaired.
- •Healthcare Providers:
- •Anesthesiologists who refuse to be part of the study
- •Nurses who refuse to be part of the study
研究组 & 干预措施
WebTIPS
A Tailored Program for Perioperative Anxiety and Pain (WebTIPS) aims at reducing perioperative anxiety and pain in children via an internet and mobile platform with short message service (SMS). The Web-based Tailored Intervention Preparation for Surgery (WebTIPS) program is developed using the conceptual framework of the Triple Aim that evaluates the intervention within the context of clinical efficacy, improved child and parent surgical experience, and reduced resource utilization during the surgical episode.
干预措施: Web-based Tailored Intervention Preparation for Surgery (Other)
Control
Subjects in this attention control group, the Web-based Information (WebINFO) group will not be provided tailored content or access to SMS. Instead, this group will only receive basic information regarding the management of perioperative anxiety and postoperative pain via the internet and/or mobile platform.
结局指标
主要结局
Assess children's domains of behavior indicating anxiety [Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents]
时间窗: Day of surgery (Holding Area, Separation, Entrance to operating room, and placement of the anesthesia mask)
Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
次要结局
- Assess Pediatric Anesthesia Emergence Delirium [Emergence status and Psychometric Evaluation in children](Baseline (Post-Anesthesia Care Unit))
- Change in children's postoperative maladaptive behaviors using the Post-Hospitalization-Behavior-Questionnaire for Ambulatory Surgery(Days 5, 7, and 14 after surgery)
- Change in children's pain intensity using the Postoperative Pain Measure (PPPM)(Days 1-14 after surgery, twice a day)
- Change in children's postoperative pain using the Faces Pain Scale-Revised (FPS-R)(Every 15 minutes for 1-2 hours while patient is in the post-anesthesia care unit)
- Change in children's postoperative pain using the Faces, Legs, Arms, Cry and Consolability pain scale (FLACC)(Every 15 minutes for 1-2 hours while patient is in the post-anesthesia care unit)
- Change in children's pain intensity using the Faces Pain Scale-Revised (FPS-R)(Days 1-14 after surgery, twice a day)
- Change in children's return to normal activity using the Pediatric Quality of Life (PedsQL) questionnaire(Days 1-14 after surgery, twice a day)
- Assess parent satisfaction outcomes using the National Research Council (NRC) Picker satisfaction survey(Day 30 after surgery)
- Change in children's postoperative pain using the visual analog scale (VAS)(Every 15 minutes for 1-2 hours while patient is in the post-anesthesia care unit)
- State-Trait Anxiety Inventory (STAI) (parent self-report)(Day of surgery (Holding area, separation, & Operating room))
研究者
Zeev Kain
Professor
University of California, Irvine