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临床试验/NCT07565142
NCT07565142已完成不适用

Medical Effects of Proximal (In-person) Intercessory (PIP) and Virtual Intercessory Prayer (VIP) on Pain and Anxiety

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Change in Pain Intensity

研究概览

简要总结

This study examines whether proximal (in-person) intercessory prayer (PIP) and virtual intercessory prayer (VIP) can reduce pain and anxiety in adults seeking care at a family medicine clinic. Participants who report moderate or higher levels of pain or anxiety will be randomly assigned to receive either brief Christian prayer (in person or virtually) or a control condition of 5 minutes of relaxing music. Prayer sessions last approximately 5 to 15 minutes and are led by trained prayer practitioners. All participants complete surveys about their pain and anxiety levels before and after the session, and again at 2 to 4 weeks and 6 to 8 weeks. The goal is to determine whether prayer leads to greater improvement in pain and anxiety symptoms compared to the control condition, whether effects differ between in-person and virtual prayer, and how participants perceive the experience.

详细描述

This is a prospective, randomized, controlled study with four groups: Immediate In-Person Prayer (Group 1), In-Person Music Control (Group 2), Immediate Virtual Prayer (Group 3), and Virtual Music Control (Group 4). Randomization uses an alternating list with equal probability of assignment to intervention or control within each arm. The PIP arm recruits patients presenting in person at University of Maryland Department of Family and Community Medicine clinics. The VIP arm recruits patients of the same clinics via email outreach, with sessions conducted over Zoom Healthcare. The prayer intervention follows a standardized Christian 5-step prayer model. The control condition consists of a 5 minutes of soothing instrumental music. Outcome assessments use the GAD-7 and likert scare for anxiety and the Numeric Pain Rating Scale for pain, collected at baseline, immediately post-intervention (except GAD-7), 2 to 4 weeks, and 6 to 8 weeks. Secondary analyses examine whether effects vary by age, gender, race/ethnicity, socioeconomic status, and religious beliefs. Participant perceptions of the prayer experience are also assessed. This is a feasibility and pilot study.

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
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

入选标准

  • Patient at a University of Maryland Department of Family and Community Medicine clinic
  • Score of 4 or more on the Numeric Pain Rating Scale (0-10) and/or score of 10 or more on the GAD-7

排除标准

  • currently pregnant
  • Change in pain or anxiety medication within 24 hours of potential enrollment

研究组 & 干预措施

Proximal (In-Person) Intercessory Prayer (PIP)

Experimental

5-15 minutes of in person PIP from a volunteer prayer practitioner following the 5-step prayer model

干预措施: Intercessory Prayer (Behavioral)

In-Person Music Control

Active Comparator

5 minutes of soothing instrumental music in a private room

干预措施: Music Listening (Behavioral)

Virtual Intercessory Prayer (VIP)

Experimental

5-15 minutes of VIP over zoom from a volunteer prayer practitioner following the 5-step prayer model

干预措施: Intercessory Prayer (Behavioral)

Virtual Music Control

Active Comparator

5 minutes of soothing instrumental music in a private zoom room

干预措施: Music Listening (Behavioral)

结局指标

主要结局

Change in Pain Intensity

时间窗: Baseline and immediately post-intervention, 2-4 weeks, and 6-8 weeks

Change in score on the Numeric Pain Rating Scale (0-10, with 10 being worst possible pain)

Change in Anxiety (Likert Scale)

时间窗: Baseline and immediately post-intervention

Change in self-reported anxiety on a Likert scale

Change in Anxiety (GAD-7)

时间窗: Baseline, 2-4 weeks, and 6-8 weeks

Change in score on the Generalized Anxiety Disorder 7-item scale (GAD-7)

次要结局

  • Participant Perception of Prayer Experience(Immediately post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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