The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT

Pain Clinical Trial

Official title:

The Feasibility of the PAINReportIt Guided Relaxation Intervention for Pain and Stress in Adult Inpatients With Sickle Cell Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02729350
• Other study ID #: IRB201500671
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: January 2026

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Pain
• Sickle Cell Disease
• Stress

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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physiologic markers of relaxation (pulse, respiration, finger temperature)	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.	Immediate (baseline)
Other	Level of relaxation	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.	Immediate (Day 1 baseline) and Day 2-5
Other	Perceived stress	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.	Baseline
Primary	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
Primary	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)
Primary	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	Current stress	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.	Immediate (Day 1 baseline) and Days 2-5
Secondary	Average stress intensity	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.	Short-term (Day 5)