The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient

NCT02729363 | Completed

• 1 other identifier: IRB201600042
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Our goal is to improve the self-management of pain and stress in adult outpatients with sickle cell disease (SCD) by determining the feasibility of a self-managed 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. Little is known about the effects or mechanisms of GR on pain and stress, in adults with SCD. 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 paucity 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 outpatients with SCD. GR is an intervention where outpatients with SCD are directed to listen to and view audio-visual recordings while they visualize themselves being immersed in that scene.

Conditions

Sickle Cell Disease; Stress; Pain

Outcome Measures

Primary Outcomes (1)

• 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 (baseline)

Secondary Outcomes (1)

• Current stress

  Immediate (baseline)

Other Outcomes (1)

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

  Immediate (baseline)

Study Arms (2)

Guided Relaxation video clip

EXPERIMENTAL

This intervention is a 12-minute guided audio-visual relaxation intervention delivered at the baseline visit to determine the immediate effects of guided relaxation intervention on stress and pain in outpatients with sickle cell disease.

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 talk about their sickle cell disease experience. The audio-taped questions and onscreen directions were programmed for self-administration. 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 audio-visual relaxation intervention.

Guided Relaxation video clip

Sickle Cell Disease Experience Discussion BEHAVIORAL

This intervention is a 12-minute computer-administered 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)
• Receives care at the University of Florida (UF) Health/Shands
• Speaks and reads English
• years of age or older
• Self-identifies as being of African or Hispanic descent

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 Hematology Clinic-Medical Plaza

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Ezenwa MO, Yao Y, Nguyen MT, Mandernach MW, Hunter CT, Yoon SL, Fedele D, Lucero RJ, Lyon D, Wilkie DJ. Randomized Pilot Study: A Mobile Technology-based Self-management Intervention for Sickle Cell Pain. West J Nurs Res. 2020 Aug;42(8):629-639. doi: 10.1177/0193945919878821. Epub 2019 Oct 4.

  PMID: 31583977 DERIVED

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: February 23, 2017
• Study Completion: March 1, 2017
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)