Sickle Cell DiseaseESPIRITUNCT06580067
The Feasibility of the Pray Until Something Happens (PUSH) Intervention-OUTPATIENT
A study testing Pray Until Something Happens (PUSH) and Self-monitoring in people with Sickle Cell Disease and Stress, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sickle Cell Disease, Stress, Pain
- What is being tested?
- Pray Until Something Happens (PUSH) and Self-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has SCD diagnosis;
- Reports pain 3 or greater in the previous 24 hours (0-10 scale)
- Speaks and reads English
- 18 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
Who cannot join
- Legally blind
- Physically or cognitively unable to complete study measures
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Sickle Cell Disease, Stress, Pain
- Being tested
- Pray Until Something Happens (PUSH), Self-monitoring
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pray Until Something Happens (PUSH)Behavioural
Also called PUSH Prayer Fellowship
Self-monitoring of outcomes + alerts/reminders + use of PUSH
Self-monitoringBehavioural
Self-monitoring of outcomes + alerts/reminder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Pray Until Something Happens (PUSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Short-term (Day 7)
Secondary outcomes (4)
Current stress
Stress intensity scale: A 3-item scale that asks patients to report their current, least, and worst stress intensity today, on a scale of 0 to 10, where 0 is "no stress" and 10 is "stress as bad as it could be." We will estimate intervention effects using linear regression.
Measured: Immediate (Day 1 baseline) and Days 2-7
Average stress intensity
Stress intensity scale: A 3-item scale that asks patients to report their current, least, and worst stress intensity today, on a scale of 0 to 10, where 0 is "no stress" and 10 is "stress as bad as it could be." We will average the three scores to create an average stress intensity score. We will estimate intervention effects using linear regression.
Measured: Short-term (Day 7)
Sleep quality
Sleep quality scale: A self-administered questionnaire that incorporates a discretizing VAS. The questionnaire instructions direct the respondent to rate the overall quality of sleep over a 7-day recall period on a discretizing VAS, whereby the respondent marks an integer score from 0 to 10, according to the following five categories: 0 = terrible, 1-3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent. When rating their sleep quality, respondents are instructed to consider the following core components of sleep quality: how many hours of sleep they had, how easily they fell asleep, how often they woke up during the night (except to go to the bathroom), how often they woke up earlier than they had to in the morning, and how refreshing their sleep was.
Measured: Immediate (Day 1 baseline) and Short-term (Day 7)
Opioid use
Measured: Immediate (Day 1 baseline) and Short-term (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start21 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miriam O Ezenwa,, PhD, RN, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580067
- Sponsor's protocol ID
- IRB202401269
- Acronym
- ESPIRITU
- Status last verified
- Jan 2025
- First submitted
- 28 Aug 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06580067
- Acronym / sponsor ID
- ESPIRITU / IRB202401269
- Conditions
- Sickle Cell Disease, Stress, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pray Until Something Happens (PUSH) video clip | Experimental | Behavioral: Pray Until Something Happens (PUSH), Behavioral: Self-monitoringThis intervention is a 30-minute petitionary prayer, named Pray Until Something Happens (PUSH) stress reduction intervention using a mobile smart device. |
| Attention Control Group | Active comparator | Behavioral: Pray Until Something Happens (PUSH)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 may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has SCD diagnosis;
- Reports pain 3 or greater in the previous 24 hours (0-10 scale)
- Speaks and reads English
- 18 years of age or older
- Uses opioid analgesics on "as needed" or "continuous" basis
Key exclusion criteria (2 listed)
- Legally blind
- Physically or cognitively unable to complete study measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pray Until Something Happens (PUSH)Also: PUSH Prayer FellowshipSelf-monitoring of outcomes + alerts/reminders + use of PUSH | Behavioural | Attention Control Group, Pray Until Something Happens (PUSH) video clip |
| Self-monitoringSelf-monitoring of outcomes + alerts/reminder | Behavioural | Pray Until Something Happens (PUSH) video clip |
Primary outcome
Current Pain
Time frame: Immediate (Day 1 baseline) and Days 2-7
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.
Average pain intensity
Time frame: Short-term (Day 7)
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.
4 secondary outcomes
Current stress
Time frame: Immediate (Day 1 baseline) and Days 2-7
Average stress intensity
Time frame: Short-term (Day 7)
Sleep quality
Time frame: Immediate (Day 1 baseline) and Short-term (Day 7)
Opioid use
Time frame: Immediate (Day 1 baseline) and Short-term (Day 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam O Ezenwa,, PhD, RN principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pray Until Something Happens (PUSH) and Self-monitoring in people with Sickle Cell Disease and Stress, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current Pain (time frame: Immediate (Day 1 baseline) and Days 2-7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.