The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT

• ClinicalTrials.gov Identifier: NCT02729350
• Recruitment Status: Unknown
• First Posted: April 6, 2016
• Last Update Posted: February 15, 2021
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Tracking Information

• First Submitted Date: March 31, 2016
• First Posted Date: April 6, 2016
• Last Update Posted Date: February 15, 2021
• Actual Study Start Date: April 2016
• Estimated Primary Completion Date: January 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 31, 2016)

• Current Pain [ Time Frame: Immediate (Day 1 baseline) and Day 2-5 ]
  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.
• Average pain intensity [ Time Frame: Short-term (Day 5) ]
  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.
• Composite pain index [ Time Frame: Short-term (Day 5) ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 31, 2016)

• Current stress [ Time Frame: Immediate (Day 1 baseline) and Days 2-5 ]
  Stress intensity scale: A 3-item scale that asks patients to report their current, least, and worst stress intensity today, on a scale of 0 to 10, where 0 is "no stress" and 10 is "stress as bad as it could be." We will estimate intervention effects using linear regression.
• Average stress intensity [ Time Frame: Short-term (Day 5) ]
  Stress intensity scale: A 3-item scale that asks patients to report their current, least, and worst stress intensity today, on a scale of 0 to 10, where 0 is "no stress" and 10 is "stress as bad as it could be." We will average the three scores to create an average stress intensity score. We will estimate intervention effects using linear regression.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 31, 2016)

• Physiologic markers of relaxation (pulse, respiration, finger temperature) [ Time Frame: Immediate (baseline) ]
  Physiological markers of relaxation (pulse, respiration, finger temperature) will be measured using a standard vital sign measuring device. We expect to observe trends for the immediate GR effect in terms of decreases in relaxation indicators (respiration rate, heart rate) and increases in skin temperature. We will estimate intervention effects using regression analysis.
• Level of relaxation [ Time Frame: Immediate (Day 1 baseline) and Day 2-5 ]
  Relaxation rating scale. A 1-item scale that asks patients to report their level of relaxation on a scale of 0 to 10, where 0 is "not at all relaxed" and 10 is "completely relaxed." We will estimate intervention effects using linear regression.
• Perceived stress [ Time Frame: Baseline ]
  Perceived Stress Questionnaire: A 30-item questionnaire that measures perceived stress in the last two weeks. An overall perceived stress index (PSI) score for each scale is computed by subtracting 30 from the raw score and dividing it by 90, yielding scores that range from 0 to 1. Higher scores indicate greater perceived stress recent. We will analyze data using linear regression.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT
• Official Title: The Feasibility of the PAINReportIt Guided Relaxation Intervention for Pain and Stress in Adult Inpatients With Sickle Cell Disease
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Sickle Cell Disease
• Stress
• Pain

Intervention

• Behavioral: 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.
• Behavioral: Sickle Cell Disease Experience Discussion
  This intervention is a 12-minute sickle cell disease experience discussion.

Study Arms

• Experimental: 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.
  Intervention: Behavioral: Guided Relaxation video clip
• 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.
  Intervention: Behavioral: Sickle Cell Disease Experience Discussion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: June 8, 2020): 45
• Original Estimated Enrollment (submitted: March 31, 2016): 40
• Estimated Study Completion Date: January 2023
• Estimated Primary Completion Date: January 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02729350
• Other Study ID Numbers: IRB201500671
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Florida
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Florida
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Miriam O Ezenwa, PhD, RN; University of Florida

• PRS Account: University of Florida
• Verification Date: February 2021