The Feasibility of the Pray Until Something Happens (PUSH) Intervention-OUTPATIENT

NCT06580067 | Completed

• 1 other identifier: IRB202401269
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Stress; Pain

Outcome Measures

Primary Outcomes (2)

• Current Pain

  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.

  Immediate (Day 1 baseline) and Days 2-7

• Average pain intensity

  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.

  Short-term (Day 7)

Secondary Outcomes (4)

• 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)

Other Outcomes (1)

• Perceived stress

  Immediate (baseline)

Study Arms (2)

Pray Until Something Happens (PUSH) video clip

EXPERIMENTAL

This intervention is a 30-minute petitionary prayer, named Pray Until Something Happens (PUSH) stress reduction intervention using a mobile smart device.

Behavioral: Pray Until Something Happens (PUSH); Behavioral: Self-monitoring

Attention Control Group

ACTIVE COMPARATOR

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.

Behavioral: Pray Until Something Happens (PUSH)

Interventions

Pray Until Something Happens (PUSH) BEHAVIORAL

Self-monitoring of outcomes + alerts/reminders + use of PUSH

Also known as: PUSH Prayer Fellowship

Attention Control Group; Pray Until Something Happens (PUSH) video clip

Self-monitoring BEHAVIORAL

Self-monitoring of outcomes + alerts/reminder

Pray Until Something Happens (PUSH) video clip

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has SCD diagnosis;
• Reports pain 3 or greater in the previous 24 hours (0-10 scale)
• Speaks and reads English
• 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

You may not qualify if:

• Legally blind
• Physically or cognitively unable to complete study measures

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Miriam O Ezenwa,, PhD, RN

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: January 21, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 30, 2026

Record last verified: 2025-01

Locations

US (1)