A Pilot Study of Everyday Stress and Pain Intensity Reduction Intervention Via Tongues and Understanding Study in Adult Outpatients With Sickle Disease (ESPIRITU Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Current Pain
研究概览
简要总结
The goal of this research study is to reduce stress and improve sickle cell disease (SCD) pain control and sleep quality with less opioid use by determining the feasibility of an intervention with self-management combined intercessory and petitionary prayer, named Pray Until Something Happens (PUSH) stress reduction intervention using a mobile smart device. Currently, opioid analgesics are primarily used to treat SCD pain while self-managed behavioral modalities such as PUSH, are rarely used. Little is known about the effects or mechanisms of PUSH on pain, stress, and sleep symptoms in adults with SCD. Emerging evidence from the hypothalamic pituitary adrenal (HPA) axis theory offer insights for understanding the mechanisms. Adding PUSH as a supplement to analgesic therapies will address the dearth of self-management strategies for controlling pain in SCD. PUSH is a simple and cost-effective non-drug intervention that could reduce pain and stress in inpatients with SCD. GR is an intervention where inpatients with SCD are directed to listen to the audio recordings of the PUSH prayer session.
详细描述
The purpose of this research study is to see if a new computerized stress reduction program, called Pray Until Something Happens (PUSH) stress reduction intervention, can be used to teach people who have sickle cell disease (SCD) how to track their stress and pain daily and use guided audio-visual relaxation exercises to help them reduce their stress and pain. To obtain preliminary data for a larger randomized controlled trial, we propose to recruit 30 adult outpatients with SCD.
The investigators will stratify patients on worst pain intensity (<=5 and >5) and randomly assign 15 adults to Attention Control (Daily stress/pain tracking on Days 1-6) and 15 adults to Experimental (PUSH Prayer Fellowship on Day 1 and daily stress/pain tracking and PUSH intervention on Days 2-6) groups.
Immediate effects on pain, stress, and relaxation responses after the PUSH Prayer Fellowship will be examined. Patients will continue the trial for additional 6 days, with self-management on Days 2-6 and posttest on Day 7 while hospitalized to test short-term (7 days) effects of PUSH on outcomes (pain, stress, sleep quality, and opioid use).
During Days 2-6, the experimental group will participate in an audio/visual Zoom recorded prayer session that will be conducted specifically for each patient by the interventionist. Following the prayer session, the link to the recorded prayer is uploaded to the PAINReportIt program. Patients will access the recorded prayer session on Days 2-6. These patients will listen to the recorded PUSH prayer session at stress onset and as often as they desire. We will investigate mechanisms by which PUSH produces its effects in adult outpatients with SCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has SCD diagnosis;
- •Reports pain 3 or greater in the previous 24 hours (0-10 scale)
- •Speaks and reads English
- •18 years of age or older
- •Uses opioid analgesics on "as needed" or "continuous" basis
- •Allows healing prayers to be offered for them in the name of Jesus Christ
排除标准
- •Legally blind
- •Physically or cognitively unable to complete study measures
研究组 & 干预措施
Attention Control Group
The second group will have access to the same internet-based application to track daily their stress and pain levels but will not be able to view our Pray Until Something Happens intervention.
干预措施: Pray Until Something Happens (PUSH) (Behavioral)
Pray Until Something Happens (PUSH) video clip
This intervention is a 30-minute petitionary prayer, named Pray Until Something Happens (PUSH) stress reduction intervention using a mobile smart device.
干预措施: Pray Until Something Happens (PUSH) (Behavioral)
Pray Until Something Happens (PUSH) video clip
This intervention is a 30-minute petitionary prayer, named Pray Until Something Happens (PUSH) stress reduction intervention using a mobile smart device.
干预措施: Self-monitoring (Behavioral)
结局指标
主要结局
Current Pain
时间窗: Immediate (Day 1 baseline) and Days 2-7
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity scale: A 3-item scale that asks patients to report their pain now, worst, and average on a scale of 1 to 5 where 1 is "had no pain" and 5 is "very severe." We will estimate intervention effects using regression analysis.
Average pain intensity
时间窗: Short-term (Day 7)
A 3-item scale that asks patients to report their current, least, and worst pain intensity today, on a scale of 0 to 10, where 0 is "no pain" and 10 is "pain as bad as it could be." We will average the three scores to create an average pain intensity score. We will estimate intervention effects using linear regression.
次要结局
- Current stress(Immediate (Day 1 baseline) and Days 2-7)
- Average stress intensity(Short-term (Day 7))
- Sleep quality(Immediate (Day 1 baseline) and Short-term (Day 7))
- Opioid use(Immediate (Day 1 baseline) and Short-term (Day 7))