Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease
15. juli 2015 opdateret af: Miriam O. Ezenwa, University of Illinois at Chicago
Stress is known to trigger acute pain crisis of sickle cell disease (SCD).
SCD is an inherited blood disorder that afflicts about 100,000 people in the United States, and is among the most common lethal genetic diseases in the United States.
Though worldwide in distribution, in the US it is most commonly found in African Americans.
Its best known complication is severe, recurrent relentless pain, often known as pain crisis.
Non-drug treatment for SCD pain such as cognitive coping interventions have been shown to be effective for reducing SCD pain intensity, but they are complicated, multifaceted, and time-consuming.
A simple and cost-effective alternative such as guided imagery (GI) could reduce the effect of stress on SCD pain.
GI is an intervention where patients listen to and view audio-visual recordings while being directed to visualize themselves being immersed in that scene or scenario.
There are no published studies on the use of GI as a simple stress coping intervention or tracking stress in a systematic manner as a trigger for SCD pain.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
28
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adults 18 years of age or older,
- Diagnosis of SCD,
- Self-reported pain of at least 3 on a 0-10 scale related to SCD,
- Spoke and read English, and
- Self-identified as being of African or Hispanic descent.
Exclusion Criteria:
- Legally blind or physically unable to complete procedures.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Guided audio-visual relaxation group
The guided relaxation (GR) intervention included a single 12-min GR video clip we administered to subjects at the baseline visit to determine the immediate effects of GR on stress and pain.
The GR intervention also included six video clips, which ranged from 2 to 20 minutes in length to determine the short-term (2-week) effects of GR on stress and pain.
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|
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Ingen indgriben: Attention Control group
For the attention control group, subjects engaged in a 12-min computer-based discussion about their sickle cell disease (SCD) experience.
The audio-taped questions and onscreen directions were programmed for self-administration.
Subjects' responses were captured via the microphone so that Data Collectors were not involved in this discussion process, and it was equivalent to the guided relation activity.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Current stress
Tidsramme: Immediate (baseline)
|
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 estimated intervention effects using linear regression with bootstrapping.
|
Immediate (baseline)
|
|
Current pain
Tidsramme: Immediate (baseline)
|
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 estimated intervention effects using linear regression with bootstrapping.
|
Immediate (baseline)
|
|
Average stress intensity
Tidsramme: Short-term (2 weeks)
|
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 averaged the three scores to create an average stress intensity score.
We estimated intervention effects using linear regression with bootstrapping.
|
Short-term (2 weeks)
|
|
Composite pain index
Tidsramme: Short-term (2 weeks)
|
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 estimated intervention effects using linear regression with bootstrapping.
|
Short-term (2 weeks)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Miriam O Ezenwa, PhD, RN, University of Illinois at Chicago
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2013
Primær færdiggørelse (Faktiske)
1. november 2014
Studieafslutning (Faktiske)
1. november 2014
Datoer for studieregistrering
Først indsendt
13. juli 2015
Først indsendt, der opfyldte QC-kriterier
15. juli 2015
Først opslået (Skøn)
17. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Protocol # 2012-1084
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Guided audio-visual relaxation
-
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-
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