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Guided Relaxation for Sickle Cell Disease

N/A

Waitlist Available

Led By Miriam O Ezenwa, PhD, RN

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Reports pain 3 or greater in the previous 24 hours (0-10 scale)

Has SCD diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trial is looking at whether a relaxation intervention using audio and visual recordings could help to reduce pain and stress for people with sickle cell disease who are in hospital.

Who is the study for?

This trial is for adult inpatients at UF Health with sickle cell disease who are experiencing pain, self-identify as African descent or Hispanic, and can speak and read English. It's not suitable for those who are legally blind, physically or cognitively unable to participate.Check my eligibility

What is being tested?

The study tests a guided relaxation (GR) video intervention on tablets to see if it helps manage pain and stress in adults hospitalized with sickle cell disease pain crises, alongside usual opioid treatments.See study design

What are the potential side effects?

Since the intervention involves non-drug methods like guided relaxation videos, there are no direct medical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have experienced pain level of 3 or more in the last day.

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I have been diagnosed with sickle cell disease.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate (baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediate (baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate (baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average pain intensity

Composite pain index

Current Pain

Secondary outcome measures

Average stress intensity

Current stress

Other outcome measures

Level of relaxation

Perceived stress

Physiologic markers of relaxation (pulse, respiration, finger temperature)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sickle cell experience discussionExperimental Treatment1 Intervention

Attention Control Group: This intervention is a 12-minute sickle cell disease experience discussion. In this computer-based discussion, patients will discuss their experience of having sickle cell disease. The audio-taped questions and onscreen directions were programmed to be self-administered. Subjects' responses will be captured via the microphone so that Data Collectors are not involved in this discussion process, and it is equivalent to the guided relaxation activity.

Group II: Guided Relaxation video clipExperimental Treatment1 Intervention

This intervention is a 12-minute guided audio-visual relaxation intervention delivered at the baseline (Day 1) visit to determine the immediate effects of guided relaxation intervention on stress and pain in inpatients with sickle cell disease. The GR intervention also includes six video clips, ranging from 2 to 20 minutes in length to determine the short-term (Day 5) effects of guided relaxation intervention on stress and pain.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Guided Relaxation video clip

2016

N/A

~30

Sickle Cell Disease Experience Discussion

2016

N/A

~30

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,633 Total Patients Enrolled

Miriam O Ezenwa, PhD, RNPrincipal InvestigatorUniversity of Florida

2 Previous Clinical Trials

58 Total Patients Enrolled

Media Library

Guided Relaxation video clip Clinical Trial Eligibility Overview. Trial Name: NCT02729350 — N/A

Sickle Cell Disease Research Study Groups: Sickle cell experience discussion, Guided Relaxation video clip

Sickle Cell Disease Clinical Trial 2023: Guided Relaxation video clip Highlights & Side Effects. Trial Name: NCT02729350 — N/A

Guided Relaxation video clip 2023 Treatment Timeline for Medical Study. Trial Name: NCT02729350 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this study currently available to prospective subjects?

"It appears that the trial, which was initially posted on April 1st 2016 and last updated February 11th 2021 is not presently in search of participants. Nevertheless, there are still 676 medical studies actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT

2016. "The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02729350.

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