40 Participants Needed

Pray Until Something Happens for Sickle Cell Disease

(ESPIRITU Trial)

DJ
MO
Overseen ByMiriam O Ezenwa, PhD, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
Must be taking: Opioid analgesics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be using opioid analgesics, so it seems you can continue with those.

What is the purpose of this trial?

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.

Research Team

MO

Miriam O Ezenwa,, PhD, RN

Principal Investigator

University of Florida

Eligibility Criteria

Adults with Sickle Cell Disease (SCD) who are 18 or older, use opioids for pain management, have experienced pain levels of 3 or higher in the past day, and are comfortable with prayers being offered for them in Jesus' name. Participants must speak and read English.

Inclusion Criteria

I can speak and read English.
I have been diagnosed with sickle cell disease.
I have experienced pain level of 3 or more in the last day.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Initial assessment of pain, stress, and sleep quality using various scales

1 day
1 visit (in-person)

Intervention

Participants in the experimental group receive the PUSH intervention, while the control group tracks stress and pain

6 days
Daily virtual sessions

Posttest

Assessment of short-term effects of the intervention on pain, stress, and sleep quality

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

1 week

Treatment Details

Interventions

  • Pray Until Something Happens (PUSH)
Trial Overview The study is testing the 'Pray Until Something Happens' (PUSH) intervention using a mobile device to see if it can reduce stress and improve pain control and sleep quality without relying heavily on opioids.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Pray Until Something Happens (PUSH) video clipExperimental Treatment2 Interventions
This intervention is a 30-minute petitionary prayer, named Pray Until Something Happens (PUSH) stress reduction intervention using a mobile smart device.
Group II: Attention Control GroupActive Control1 Intervention
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.

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Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

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Recruited
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