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

46 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this research study is to improve the self-management of pain, stress, and cognitive/affective symptoms that may result in adult inpatients with sickle cell disease (SCD) by determining the feasibility of a self-management guided relaxation (GR) stress reduction intervention using a tablet-based mobile device. Currently, opioid analgesics are primarily used to treat SCD pain while self-managed behavioral modalities such as GR, are rarely used, particularly, in inpatient settings. Little is known about the effects or mechanisms of GR on pain, stress, and cognitive/affective symptoms in adults with SCD hospitalized with pain. Emerging evidence from the hypothalamic pituitary adrenal (HPA) axis theory offer insights for understanding the mechanisms. Adding GR as a supplement to analgesic therapies will address the dearth of self-management strategies for controlling pain in SCD. 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 SCD are directed to listen to and view audio-visual recordings while they visualize themselves being immersed in that scenario.

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 data supports the effectiveness of the treatment Guided Relaxation video clip for Sickle Cell Disease?

Research shows that guided relaxation, including video-based interventions, can help reduce stress and pain in people with sickle cell disease. Studies have found that these relaxation techniques can lead to fewer emergency room visits and hospitalizations, as well as improvements in pain management and quality of life. ^{1 2 3 4 5}

Is guided relaxation safe for people with sickle cell disease?

Guided relaxation, including video and audio-visual interventions, has been tested in people with sickle cell disease and found to be feasible and acceptable, with no reported safety concerns in the studies. ^{1 2 4 6 7}

How does the guided relaxation treatment differ from other treatments for sickle cell disease?

Guided relaxation for sickle cell disease is unique because it uses video clips to help patients manage pain and stress through relaxation techniques, unlike traditional treatments that often focus on medication. This approach is non-invasive and can be self-managed, offering a complementary option to standard pain management strategies. ^{1 2 3 5 8}

Research Team

Miriam Ezenwa, PhD, RN, FAAN

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized Pilot Study: A Mobile Technology-based Self-management Intervention for Sickle Cell Pain. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Management of pain in sickle cell disease using biofeedback therapy: a preliminary study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Single-session biofeedback-assisted relaxation training in children with sickle cell disease. [2012]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events of procedural sedation and analgesia in a pediatric emergency department. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Brief report: sleep in children with sickle cell disease: an analysis of daily diaries utilizing multilevel models. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Hypnotically induced pain control in sickle cell anemia. [2011]