Pray Until Something Happens for Sickle Cell Disease

(ESPIRITU Trial)

Overseen By Miriam O Ezenwa, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must be taking: Opioid analgesics

Disqualifiers: Legally blind, physically or cognitively unable

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with sickle cell disease (SCD) manage pain and stress. It examines a prayer-based approach called PUSH (Pray Until Something Happens), practiced via a mobile device, to determine if it can reduce opioid use and improve sleep. Participants will either engage in PUSH prayer sessions or track their stress and pain levels online without the prayer component. Ideal participants are English speakers with SCD who experience significant pain and are open to receiving healing prayers. As an unphased trial, this study offers participants the chance to explore innovative, non-drug approaches to managing SCD symptoms.

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 prior data suggests that the Pray Until Something Happens (PUSH) intervention is safe for reducing stress and pain in sickle cell disease patients?

Research has shown that the Pray Until Something Happens (PUSH) program helps people with sickle cell disease manage stress and pain. PUSH involves a prayer session accessible on a mobile device, avoiding drugs or physical treatments. As a result, it does not cause typical side effects associated with medications.

No specific reports of negative effects from the PUSH program have emerged. As a non-drug, self-help method, it is generally well-tolerated. PUSH aims to reduce stress and pain and improve sleep without the side effects often linked to opioid medications used for sickle cell pain. Although more research is needed to fully understand its effects, PUSH offers a promising and safe way to manage pain and stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pray Until Something Happens (PUSH) treatment for sickle cell disease because it explores a unique approach to stress management through a 30-minute petitionary prayer delivered via a mobile smart device. Unlike conventional treatments that focus on managing pain with medications like hydroxyurea or blood transfusions, PUSH offers a non-medical intervention aimed at reducing stress, which can be a significant trigger for pain episodes in sickle cell patients. By integrating technology and spirituality, PUSH could offer a complementary strategy to improve quality of life for those living with this condition.

What evidence suggests that the Pray Until Something Happens (PUSH) intervention might be effective for sickle cell disease?

Research shows that many people with sickle cell disease (SCD) use prayer to help manage their condition. Studies suggest that regular prayer can lead to better health, particularly for those experiencing stress and pain from SCD. In this trial, participants in one arm will engage in the Pray Until Something Happens (PUSH) approach, which is based on the idea that prayer can help reduce stress and improve pain management. Although specific data on PUSH's effectiveness is lacking, it relies on the belief that spirituality and religious practices can positively affect well-being. This non-drug method might complement current pain management strategies for SCD. ^{6 7 8 9 10}

Who Is on the Research Team?

Miriam O Ezenwa,, PhD, RN

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Pray Until Something Happens (PUSH) video clip Experimental Treatment 2 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4609442/

Religious Coping and the Use of Prayer in Children With ... While adolescents and adults with sickle cell disease (SCD) have reported using religion to cope with SCD, there is no data examining religious ...

2. scielo.br scielo.br/j/reben/a/QPXY59kTqm4tm5K938kDBJn/?lang=en

Spirituality/Religiosity in coping with sickle cell disease Individuals with sickle cell disease experience spirituality/religiosity motivated by their hope for a miracle, and fear of death.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6395545/

Relation between religious perspectives and views on sickle ... The present study focused on religious and cultural aspects of SCD with the view to identifying beliefs and attitudes relevant to public health interventions ...

4. epublications.marquette.edu epublications.marquette.edu/cgi/viewcontent.cgi?article=1340&context=dissertations_mu

Spirituality And Religiosity In Adolescents With Sickle Cell ... Analysis of data suggests that moderate frequency of prayer has better outcomes in comparison to low or high extremes of prayer. This finding suggests that ...

5. hopkinsmedicine.org hopkinsmedicine.org/news/newsroom/news-releases/2025/06/no-more-pain-breakthrough-sickle-cell-treatment-from-johns-hopkins-offers-curative-potential

No More Pain: Breakthrough Sickle Cell Treatment ... The approach has proven curative in 90% of adult patients treated, and it is now reshaping what is possible for people with SCD. “It's very rare ...

6. trialx.com trialx.com/clinical-trials/listings/306442/the-feasibility-of-the-pray-until-something-happens-push-intervention-outpatient/

The Feasibility of the Pray Until Something Happens ... The goal of this research study is to reduce stress and improve sickle cell disease (SCD) pain control and sleep quality with less opioid ...

7. reporter.nih.gov reporter.nih.gov/search/13EFC8094685C0D67598B8961CAA4A01A2FFCEB861BF/project-details/11142406

ENhancing Care in the Emergency Department (SCIENCE) Sickle cell disease (SCD) is an inherited blood disorder affecting approximately 36,000 children in the United States, approximately 90% of whom are Black.

8. centerwatch.com centerwatch.com/clinical-trials/listings/location/united-states/FL/Gainesville

Gainesville, Florida Clinical Research Trials The purpose of this research study is to see if a new computerized stress reduction program, called Pray Until Something Happens (PUSH) stress reduction ...

9. unitytrials.org unitytrials.org/trials/detail/NCT06580067-the-feasibility-of-the-pray-until-something-happens

The Feasibility of the Pray Until Something Happens (PUSH ... 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 ...

10. reporter.nih.gov reporter.nih.gov/project-details/11280765

Project Details - NIH RePORTER Pain is also the primary cause of hospitalization in patients with SCD and is correlated with increased morbidity, mortality, and healthcare costs, contributing ...