The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT

NCT ID: NCT02729350

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-03-31

Brief Summary

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.

Detailed Description

The purpose of this research study is to see if a new computerized stress reduction program, called PAINReportIt Guided Relaxation Intervention, can be used to teach people who have sickle cell disease (SCD) how to track their stress and pain daily and use guided audio-visual relaxation exercises to help them reduce their stress and pain. To obtain preliminary data for a larger trial, 30 adult inpatients with SCD admitted with SCD pain will be recruited.

The investigators will stratify patients on worst pain intensity (<=5 and >5) and randomly assign 15 adults to Attention Control (12-min SCD experience discussion on Day 1 and daily stress/pain tracking on Days 2-4) and 15 adults to Experimental (12-min GR video clip on Day 1 and daily stress/pain tracking and GR on Days 2-4) groups.

Immediate effects on pain, stress, and relaxation responses after the 12-min session will be examined. Patients will continue the trial for additional 4 days, with self-management on Days 2-4 and posttest on Day 5 while hospitalized to test short-term effects.

During Days 2-4, the experimental group will choose and watch any of six video clips (2 min, 5 min, 8 min, 10 min, 15 min, and 20 min lengths) at least once a day; and at stress onset and as often as they need. We will investigate mechanisms by which GR produces its effects in adult inpatients with SCD.

Conditions

Sickle Cell Disease; Stress; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Guided Relaxation video clip

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.

Group Type: EXPERIMENTAL

Guided Relaxation video clip

Intervention Type: BEHAVIORAL

This intervention is a 12-minute guided relaxation intervention for reducing pain and stress in adult inpatients with sickle cell disease.

Sickle cell experience discussion

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 Type: OTHER

Sickle Cell Disease Experience Discussion

Intervention Type: BEHAVIORAL

This intervention is a 12-minute sickle cell disease experience discussion.

Interventions

Guided Relaxation video clip

This intervention is a 12-minute guided relaxation intervention for reducing pain and stress in adult inpatients with sickle cell disease.

Intervention Type: BEHAVIORAL

Sickle Cell Disease Experience Discussion

This intervention is a 12-minute sickle cell disease experience discussion.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Has SCD diagnosis;
• Reports pain 3 or greater in the previous 24 hours (0-10 scale)
• admitted to University of Florida (UF) Health for pain crisis
• Speaks and reads English
• 18 years of age or older
• self-identifies as being of African descent or Hispanic

Exclusion Criteria

• Legally blind
• Physically or cognitively unable to complete study measures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miriam O Ezenwa, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201500671

Identifier Type: -

Identifier Source: org_study_id