Guided Relaxation for Sickle Cell Disease

Recruiting in Palo Alto (17 mi)

Overseen byMiriam Ezenwa, PhD, RN, FAAN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Florida

No Placebo Group

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.

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

See 3 more

Exclusion Criteria

I am legally blind.

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

Treatment Details

Interventions

Guided Relaxation video clip (Behavioural Intervention)

Trial OverviewThe 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

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.