Guided Relaxation for Sickle Cell Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether guided relaxation can help manage pain and stress in hospitalized adults with sickle cell disease (SCD). Participants will watch short relaxation videos on a tablet to determine if this can complement traditional pain treatments like opioids. The trial also includes a control group where participants discuss their experiences with SCD. Suitable participants should have SCD, have recently experienced significant pain, and be admitted to UF Health for a pain crisis. As an unphased trial, this study offers participants the chance to explore innovative pain management techniques that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on adding guided relaxation as a supplement to existing treatments for pain management in sickle cell disease.

What prior data suggests that this guided relaxation intervention is safe for inpatients with sickle cell disease?

Research has shown that guided relaxation is safe for people with sickle cell disease. Previous studies have explored its use as an easy, non-drug method to manage pain and stress. These studies found no major side effects for those using guided relaxation techniques. This method involves listening to and watching calming audio and video recordings to help reduce pain and stress. Although more remains to be learned about its mechanisms, the evidence so far suggests it is safe for people with sickle cell disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the guided relaxation treatment for sickle cell disease because it offers a non-drug approach to managing stress and pain. Unlike the standard care options like pain medications and blood transfusions, guided relaxation uses a soothing audio-visual method to potentially provide immediate relief. This technique is particularly appealing as it empowers patients with a self-administered tool that could reduce reliance on medications and enhance overall well-being.

What evidence suggests that guided relaxation is effective for managing pain and stress in sickle cell disease?

Research has shown that guided relaxation (GR) can reduce pain and stress in people with sickle cell disease (SCD). In this trial, participants will watch a guided relaxation video clip featuring calming scenes as an experimental non-drug method. For individuals with SCD, this approach may lower pain levels and reduce the need for pain medications like opioids. By calming the mind, GR might also manage stress and improve mood. Early evidence suggests that GR offers a simple and affordable way to support other pain treatments for SCD. ^{1 2 3 6 7}

Who Is on the Research Team?

Miriam Ezenwa, PhD, RN, FAAN

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Admitted to University of Florida (UF) Health for pain crisis

Speaks and reads English

Self-identifies as being of African descent or Hispanic

Exclusion Criteria

I am legally blind.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Participants are assigned to either the Guided Relaxation or Attention Control group and receive a 12-minute intervention

1 day

1 visit (in-person)

Intervention

Participants engage in daily stress/pain tracking and guided relaxation or discussion activities

4 days

Daily in-person sessions

Follow-up

Participants are monitored for short-term effects on pain and stress

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Guided Relaxation video clip

Trial Overview

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.

How Is the Trial Designed?

Group I: Sickle cell experience discussion Experimental Treatment 1 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 clip Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

The GRACE study is evaluating the effectiveness of guided relaxation and acupuncture for managing chronic pain in sickle cell disease, involving 366 participants randomized into two intervention groups or usual care over a 24-week period.

The primary focus is on measuring changes in pain impact scores, along with secondary outcomes like opioid use and mental health factors, to determine the best treatment approach tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol. Doorenbos, AZ., Schlaeger, JM., deMartelly, VA., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9958255/

Hybrid effectiveness-implementation trial of guided ...

The results from GRACE will represent a critical step toward improving management of pain affecting patients with sickle cell disease. ClinicalTrials.gov ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04906447

Hybrid Effectiveness-Implementation Trial of Guided ...

Aim 1: Determine the effectiveness of guided relaxation and acupuncture as compared to usual care in decreasing pain and opioid use for SCD patients. Hypothesis ...

3.

withpower.com

withpower.com/trial/guided-relaxation-for-sickle-cell-disease-00df6

Guided Relaxation for Sickle Cell Disease

GR 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 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12329658/

Challenges and Strategies: Nationwide Data Collection for ...

Pain of sickle cell disease (SCD) is often stressful and increases the need for opioids. Relaxation/distraction interventions may reduce ...

5.

researchgate.net

researchgate.net/publication/390490035_Challenges_and_Strategies_Nationwide_Data_Collection_for_an_Internet-based_Guided_Relaxation_Intervention_in_Sickle_Cell_Disease

Nationwide Data Collection for an Internet-based Guided ...

Challenges and Strategies: Nationwide Data Collection for an Internet-based Guided Relaxation Intervention in Sickle Cell Disease.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10887359/

Mindfulness and yoga therapy for acute pain in sickle cell ...

The purpose of this pilot study was to assess the acceptability and feasibility of video‐guided mindfulness meditation, breathing exercises, and yoga.

7.

nursing.uic.edu

nursing.uic.edu/research/hybrid-effectiveness-implementation-trial-of-guided-relaxation-and-acupuncture-for-chronic-sickle-cell-disease-pain/

Hybrid effectiveness-implementation trial of guided relaxation ...

Results from this research may reduce opioid use and improve pain management among sickle cell disease patients. Principal Investigator: Doorenbos, Ardith Z.