The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT

NCT02729350 | Completed

• 1 other identifier: IRB201500671
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Stress; Pain

Outcome Measures

Primary Outcomes (3)

• Current Pain

  Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity scale: A 3-item scale that asks patients to report their pain now, worst, and average on a scale of 1 to 5 where 1 is "had no pain" and 5 is "very severe." We will estimate intervention effects using regression analysis.

  Immediate (Day 1 baseline) and Day 2-5

• Average pain intensity

  PAINReportIt® Pain intensity scale: A 3-item scale that asks patients to report their current, least, and worst pain intensity today, on a scale of 0 to 10, where 0 is "no pain" and 10 is "pain as bad as it could be." We will average the three scores to create an average pain intensity score. We will estimate intervention effects using linear regression.

  Short-term (Day 5)

• Composite pain index

  PAINReportIt® Composite pain index (CPI): A a multidimensional representation of pain calculated by averaging the individual proportional scores for each of the four pain dimensions: (1) number of pain sites; (2) pain intensity; (3) total pain rating index (from the McGill Pain Questionnaire \[MPQ\], pain quality); and (4) pain pattern score. The scores for the CPI range from 0 to 100. We will estimate intervention effects using linear regression.

  Short-term (Day 5)

Secondary Outcomes (2)

• Current stress

  Immediate (Day 1 baseline) and Days 2-5

• Average stress intensity

  Short-term (Day 5)

Other Outcomes (3)

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

  Immediate (baseline)

• Level of relaxation

  Immediate (Day 1 baseline) and Day 2-5

• Perceived stress

  Baseline

Study Arms (2)

Guided Relaxation video clip

EXPERIMENTAL

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.

Behavioral: Guided Relaxation video clip

Sickle cell experience discussion

OTHER

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.

Behavioral: Sickle Cell Disease Experience Discussion

Interventions

Guided Relaxation video clip BEHAVIORAL

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

Guided Relaxation video clip

Sickle Cell Disease Experience Discussion BEHAVIORAL

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

Sickle cell experience discussion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• self-identifies as being of African descent or Hispanic

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Miriam O Ezenwa, PhD, RN

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 6, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)