Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-01 @ 4:35 PM
Study NCT ID:
NCT06580067
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2024-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Feasibility of the Pray Until Something Happens (PUSH) Intervention-OUTPATIENT
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
A Pilot Study of Everyday Stress and Pain Intensity Reduction Intervention Via Tongues and Understanding Study in Adult Outpatients With Sickle Disease (ESPIRITU Study)
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESPIRITU
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: