此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

青少年脊柱手术准备和恢复的数字健康心理社会干预 (SurgeryPal)

2026年8月31日 更新者:Jennifer Rabbitts, MBChB、Seattle Children's Hospital

MHealth 社会心理干预预防青少年术后疼痛从急性向慢性转变的有效性

This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).

研究概览

详细说明

Major musculoskeletal surgeries are associated with particularly high prevalence of both acute and chronic post-surgical pain (CPSP), with 80% of youth reporting intense acute pain after hospital discharge, and up to half reporting CPSP up to one year after spine surgery. Interventions to improve recovery and reduce pain after surgery have potential to interrupt a negative trajectory of suffering and disability associated with chronic pain. Our specific aims are: Primary: (1) Determine effectiveness of a pre-operative mHealth psychosocial intervention to improve acute pain outcomes in adolescents undergoing major musculoskeletal surgery, (2) Determine effectiveness of a post-operative mHealth psychosocial intervention to improve chronic pain outcomes at 3 months in adolescents undergoing major musculoskeletal surgery, (3) Determine the combined effects of pre- and post-operative psychosocial intervention on chronic pain outcomes. Secondary: (1) Determine effectiveness of pre-operative psychosocial intervention to reduce opioid use during the 14 days following hospital discharge, (2) Determine effectiveness of psychosocial intervention to improve health-related quality of life following surgery.

研究类型

介入性

注册 (实际的)

433

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Washington
      • Seattle、Washington、美国、98105
        • Seattle Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Teen

  • 12 to 18 years old at the time of enrollment
  • Undergoing scheduled spinal fusion surgery (eligible indications: juvenile/adolescent idiopathic scoliosis, congenital scoliosis, spondylolisthesis or kyphosis)

Parent/Caregiver

  • Parent or legal guardian of child who meets study criteria

Exclusion Criteria:

Teen

  • Does not speak or understand English
  • Has severe learning disability, cognitive impairment or intellectual delay (i.e. unable to read at 5th grade level)
  • Does not have access to a smart device (smartphone, iPad or tablet; Teens can borrow an iPad from the study team if one is available)
  • Recent psychiatric admission (in the past 30 days)
  • Severe systemic disease (neuromuscular scoliosis, cancer)
  • On a regular treatment regimen for a severe chronic medical condition
  • Prior major surgery (open surgery such as heart, lung, brain, abdominal surgery, or prior spine surgery)
  • Diagnosed chronic musculoskeletal pain condition (e.g. complex regional pain syndrome, fibromyalgia, widespread musculoskeletal pain)

Parent/Caregiver

  • Does not speak or understand English
  • Does not have access to a smart device (smartphone, iPad or tablet)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器:Pre-operative and Post-operative Education intervention

This arm receives access to Patient Education intervention in the pre- and post-operative phases.

The patient education website will serve as the active comparator. The purpose is to control for time, attention, and online usage. Youth and parents will be provided access to an education website containing information about pediatric surgery at the same time interval as the active intervention; however, there will be no exposure to cognitive and behavioral coping skills. Similar to the CBT condition, the presurgery period of Education will be administered for one month prior to surgery and the postsurgery period will be administered for one month after the post-discharge assessment.

实验性的:Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention

This arm receives access to CBT intervention in the pre-operative phase and Patient Education in the post-operative phase.

The patient education website will serve as the active comparator. The purpose is to control for time, attention, and online usage. Youth and parents will be provided access to an education website containing information about pediatric surgery at the same time interval as the active intervention; however, there will be no exposure to cognitive and behavioral coping skills. Similar to the CBT condition, the presurgery period of Education will be administered for one month prior to surgery and the postsurgery period will be administered for one month after the post-discharge assessment.

The SurgeryPal intervention is a cognitive-behavioral program for youth undergoing major surgery. SurgeryPal is delivered in two 4-week phases: the pre-operative phase, and the post-operative phase. Each phase consists of 3 separate treatment modules for youth and parents, which teach cognitive and behavioral coping skills to target known psychosocial and behavioral risk factors (i.e. anxiety/distress and sleep disturbance) for poorer postsurgical outcomes, and provide training in pain self-management skills. Pre-operative modules include: 1) Preparing for surgery, 2) Coping with stress before surgery, and 3) Getting ready for the hospital. Postoperative modules include: 1) Coping at home after surgery, 2) Return to activities and school, and 3) Long-term recovery. Modules are self-guided and interactive, and focus on phases of preparation and recovery from surgery. The goal of the program is to reduce pain and enhance quality of life following surgery in youth.

实验性的:Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal)

This arm receives access to Patient Education intervention during the pre-operative period and CBT intervention during the post-operative period.

The patient education website will serve as the active comparator. The purpose is to control for time, attention, and online usage. Youth and parents will be provided access to an education website containing information about pediatric surgery at the same time interval as the active intervention; however, there will be no exposure to cognitive and behavioral coping skills. Similar to the CBT condition, the presurgery period of Education will be administered for one month prior to surgery and the postsurgery period will be administered for one month after the post-discharge assessment.

The SurgeryPal intervention is a cognitive-behavioral program for youth undergoing major surgery. SurgeryPal is delivered in two 4-week phases: the pre-operative phase, and the post-operative phase. Each phase consists of 3 separate treatment modules for youth and parents, which teach cognitive and behavioral coping skills to target known psychosocial and behavioral risk factors (i.e. anxiety/distress and sleep disturbance) for poorer postsurgical outcomes, and provide training in pain self-management skills. Pre-operative modules include: 1) Preparing for surgery, 2) Coping with stress before surgery, and 3) Getting ready for the hospital. Postoperative modules include: 1) Coping at home after surgery, 2) Return to activities and school, and 3) Long-term recovery. Modules are self-guided and interactive, and focus on phases of preparation and recovery from surgery. The goal of the program is to reduce pain and enhance quality of life following surgery in youth.

实验性的:Pre-operative and Post-operative CBT intervention (SurgeryPal)

This arm receives access to CBT intervention during the pre-operative and post-operative period.

The SurgeryPal intervention is a cognitive-behavioral program for youth undergoing major surgery. SurgeryPal is delivered in two 4-week phases: the pre-operative phase, and the post-operative phase. Each phase consists of 3 separate treatment modules for youth and parents, which teach cognitive and behavioral coping skills to target known psychosocial and behavioral risk factors (i.e. anxiety/distress and sleep disturbance) for poorer postsurgical outcomes, and provide training in pain self-management skills. Pre-operative modules include: 1) Preparing for surgery, 2) Coping with stress before surgery, and 3) Getting ready for the hospital. Postoperative modules include: 1) Coping at home after surgery, 2) Return to activities and school, and 3) Long-term recovery. Modules are self-guided and interactive, and focus on phases of preparation and recovery from surgery. The goal of the program is to reduce pain and enhance quality of life following surgery in youth.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Post-surgical Pain Severity and Interference
大体时间:1-14 days post-hospital-discharge, up to 3 weeks post-surgery (T2)

The Brief Pain Inventory (BPI) has 2 scales: pain severity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain severity or interference (worse). The 24 hour (short) version of this measure will be completed via REDCap daily for 14 days post-discharge (beginning on day 1 after hospital discharge, and ending on day 14, up to a maximum of 3-weeks post-surgery). Daily scores from days 1-14 post-hospital-discharge were averaged for each participant, and mean values across all participants are reported here.

1-14 days post-hospital-discharge, up to 3 weeks post-surgery (T2)
Chronic Pain Severity and Interference
大体时间:3 months post-surgery (T3)

The Brief Pain Inventory (BPI) has 2 scales: pain severity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain severity or interference (worse). The 24 hour (short) version of this measure will be completed via REDCap daily for 7 days at 3 months after the participant's surgery date. Daily scores across the 7 days were averaged for each participant, and mean values across all participants are reported here.

3 months post-surgery (T3)

次要结果测量

结果测量
措施说明
大体时间
Change in Health-related Quality of Life
大体时间:Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)

The Pediatric Quality of Life Inventory (Peds-QL) 15-item short form assesses several domains of functioning, including physical, social, emotional, and academic functioning. The PedsQL is widely used and demonstrates good reliability for both the parent and child self-report measures. Scale scores (all scales, including both total and subscales) range from 0 to 100. Higher scores indicate fewer difficulties (better) health-related quality of life. Subscales of physical and psychosocial health will be used in analyses.

Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Opioid Use
大体时间:Up to 3 weeks post-surgery (T2), 3-months post-surgery (T3), 6-months post-surgery (T4)

Youth will report medication use on the Brief Pain Inventory (BPI), including selecting medication name from a dropdown list (opioid, acetaminophen, anti-inflammatory, other). Number of days of opioid use will be used in analyses.

Up to 3 weeks post-surgery (T2), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Opioid Misuse
大体时间:Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)

The American Psychiatric Association (APA) Adapted National Institute for Drug Abuse (NIDA) Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Level 2 Tool (Teen Report) recommended by the National Institute on Drug Abuse for substance use screening in adolescents, will be used to assess opioid misuse. Additional questions on reasons for misuse (e.g. to treat pain, to get high, etc.) and source of opioids (e.g. prescription, from a friend or relative) will be collected using the corresponding questions and response options used in the National Survey on Drug Use and Health. For analysis, we will report the percentage of participants that endorsed any opioid misuse at each assessment.

Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Psychosocial Distress
大体时间:Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)

The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms that evaluates negative mood, view of self and social cognitions. Response options range from 1 (Never) to 5 (Almost Always). Raw scores for anxiety and depression are obtained by summing the corresponding items' response values, and range from 8 to 40 with higher scores indicating higher distress. Raw scores and T-scores are computed with higher T-scores above 60 indicating clinically elevated (worse) symptoms. The general population mean T-score is 50, with a standard deviation of 10. Anxiety T-scores range from 33.5-83.3, and depression T-scores range from 35.2-82.4. T-scores are reported here.

Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Mental Health
大体时间:Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)

Parents and teens will self-report on the Patient Health Questionnaire-4, a 4 item screening measure of general anxiety and depressive symptoms. Response options range from 0 (Not at all) to 3 (Nearly Every Day). Total scores are calculated by summing items, for a total score ranging from 0 to 12, with higher scores indicating greater anxiety and depressive symptoms (poorer outcome).

Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Sleep Quality
大体时间:Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)

The Adolescent Sleep Wake Scale 10-item version (Teen Report) is a 10-item measure that assesses self-reported sleep quality. Scale scores (including both individual/subscale and total scores) range from 1 to 6 with higher scores indicating better sleep quality. The total score reported here is the average of all subscale scores.

Baseline (T1), 3-months post-surgery (T3), 6-months post-surgery (T4)
Change in Pain Catastrophizing
大体时间:Baseline (T1), 3-months post-surgery (T3)

The Pain Catastrophizing Scale - Child Version and Parent Version is a Self-report 13 item measures that assess child pain catastrophizing and parent's catastrophizing about child's pain, respectively. Total scores range from 0 to 52 with higher scores indicating greater pain catastrophizing (worse).

Baseline (T1), 3-months post-surgery (T3)
Global Pain Severity
大体时间:Up to 3 weeks post-surgery (T2), 3-months post-surgery (T3), 6-months post-surgery (T4)

The Patient Global Impression of Severity Scale (PGIS), Teen Report is a 1-item measure that assesses adolescent's self-reported global impression of pain severity. Response options range from 0 (none) to 3 (severe) with higher scores indicating higher pain severity (worse).

Up to 3 weeks post-surgery (T2), 3-months post-surgery (T3), 6-months post-surgery (T4)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tonya Palermo, PhD、Seattle Children's Hospital
  • 首席研究员:Jennifer Rabbitts, MD、Seattle Children's Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年12月29日

初级完成 (实际的)

2025年5月21日

研究完成 (实际的)

2025年5月21日

研究注册日期

首次提交

2020年11月6日

首先提交符合 QC 标准的

2020年11月16日

首次发布 (实际的)

2020年11月20日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年8月31日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

A releasable database for underlying primary data for publications will be made broadly available on the NIH HEAL Initiative central data repository. The database will be produced and will be completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act (HIPAA). The DCC will also prepare a data dictionary that provides a concise definition of every data element included in the database. In accordance with policies of the NIH, the DCC will send the releasable database to the entity determined by the NIH or specific institute to be the repository for data created under the HEAL initiative. The DCC is able to produce a relational database export, or use SAS or SPSS data sets. The DCC will accompany the database with full documentation so that individual investigators will be able to effectively use the data.

IPD 共享时间框架

After last subject enrollment and all follow up procedures have been completed, the HEAL Pain Management Effectiveness Research Network Data Coordinating Center (DCC) at the University of Utah will prepare a final study database for the trial, which will then be used for statistical analyses and publication of findings from the trial. The policies for release of this database are in accordance with the HEAL Data Sharing policy as determined by the NIH. Our preliminary plan is to release the underlying primary database at the time of publication of the primary manuscript. The primary publication from the dataset will be made publicly available immediately without any embargo period through the Creative Commons Generic License in accordance with the HEAL Public Access guidance. Additional secondary publications will be deposited electronically within 4 weeks of acceptance into PubMed Central.

IPD 共享访问标准

Access to the releasable database housed in the NIH-assigned repository will be in accordance with procedures and regulations of the NIH or specific institute. The DCC will not provide any support for investigators using the releasable database.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅