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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

Must not have

Legally blind

Physically or cognitively unable to complete study measures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am legally blind.

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I cannot complete study tasks due to physical or mental reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate (day 1 baseline) and day 2-5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediate (day 1 baseline) and day 2-5

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate (day 1 baseline) and day 2-5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average pain intensity

Composite pain index

Current Pain

Secondary study objectives

Average stress intensity

Current stress

Other study objectives

Level of relaxation

Perceived stress

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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