Evidence map›Paper›PMID 36852100›Full record

ArticleContemporary clinical trials communications2023

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol.

Ardith Z Doorenbos, Judith M Schlaeger, Victoria A deMartelly, Larisa A Burke, Andrew D Boyd, Mitchell R Knisely, Jonathan W Leigh, Hongjin Li, Molly W Mandernach, Robert E Molokie and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04906447 (Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04906447 phase2completednot on this map

Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain

TypeinterventionalSponsorUniversity of Illinois at ChicagoRan2021 to 2026Enrolled379ConditionsSickle Cell DiseaseArmsGuided Relaxation, Acupuncture
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Article
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  11. Precision, integrative medicine for pain management in sickle cell disease.Frontiers in pain research (Lausanne, Switzerland) · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ardith Z DoorenbosCollege of Nursing, University of Illinois Chicago, 845 S. Damen, Chicago, IL, 60612, USA.
Judith M SchlaegerCollege of Nursing, University of Illinois Chicago, 845 S. Damen, Chicago, IL, 60612, USA.
Victoria A deMartellyCollege of Nursing, University of Illinois Chicago, 845 S. Damen, Chicago, IL, 60612, USA.
Larisa A BurkeCollege of Nursing, University of Illinois Chicago, 845 S. Damen, Chicago, IL, 60612, USA.
Andrew D BoydCollege of Applied Health Sciences, 1919 W Taylor St, Chicago, IL, 60612, USA.
Mitchell R KniselySchool of Nursing, Duke University, 307 Trent Drive, Durham, NC, 27710, USA.
Jonathan W LeighCollege of Nursing, University of Illinois Chicago, 845 S. Damen, Chicago, IL, 60612, USA.
Hongjin LiCollege of Nursing, University of Illinois Chicago, 845 S. Damen, Chicago, IL, 60612, USA.
Molly W MandernachDepartment of Medicine, UF Health, PO Box 100278, Gainesville, FL, 32610, USA.
Robert E MolokieCollege of Applied Health Sciences, 1919 W Taylor St, Chicago, IL, 60612, USA.
Crystal L PatilCollege of Nursing, University of Illinois Chicago, 845 S. Damen, Chicago, IL, 60612, USA.
Alana D SteffenCollege of Nursing, University of Illinois Chicago, 845 S. Damen, Chicago, IL, 60612, USA.
Nirmish ShahDepartment of Medicine, Duke University, 40 Medicine Circle, Durham, NC, 27710, USA.
Miriam O EzenwaCollege of Nursing, University of Florida, 1225 Center Drive, PO Box 100197, Gainesville, FL, 32610-0197, USA.

Funding

NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · NCCIH · DUKE UNIVERSITY · PI LESLEY H CURTIS, Adrian Hernandez · 2017 to 2026
$21.5M
HEAL Collaboratory Resource Coordinating Center (PRISM) (U24): Bioethics SupplementU24AT010961 · NCCIH · DUKE UNIVERSITY · PI CURTIS, LESLEY H, HERNANDEZ, ADRIAN · 2019 to 2021
$6.4M
Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease PainUH3AT011265 · NCCIH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI DOORENBOS, ARDITH Z, EZENWA, MIRIAM OMELEBELE · 2021 to 2024
$6.4M
Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease PainUG3AT011265 · NCCIH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI DOORENBOS, ARDITH Z, EZENWA, MIRIAM OMELEBELE · 2020 to 2020
$827k
Providing training in effective non-opioid options for the treatment of pain conditions.K24AT011995 · NCCIH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI DOORENBOS, ARDITH Z · 2021 to 2021
$324k
NCCIH NIH HHS K24 AT011995NCCIH NIH HHS U24 AT009676NCCIH NIH HHS U24 AT010961NCCIH NIH HHS UG3 AT011265NCCIH NIH HHS UH3 AT011265
6 · The paper itself

Abstract

Background: People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems. Methods: Participants (N = 366) are being recruited and randomized 1:1:1 to one of 2 intervention groups or usual care. The acupuncture intervention group receives 10 sessions over approximately 5 weeks. The guided relaxation intervention group receives access to video sessions ranging from 2 to 20 min each viewed daily over 5 weeks. The usual care group receives the standard of clinical care for sickle cell disease. Participants are re-randomized at 6 weeks depending on their pain impact score. Assessments occur at 6 weeks, 12 weeks, and 24 weeks. The primary outcome is the change in pain impact score and secondary measures include opioid use, anxiety, depression, sleep, pain catastrophizing, substance use, global impression of change, constipation, and hospitalizations. The GRACE study uses the Consolidated Framework for Implementation Research to plan, execute, and evaluate the associated implementation processes. Conclusion: The results from GRACE will represent a critical step toward improving management of pain affecting patients with sickle cell disease.ClinicalTrials.gov Identifier: NCT04906447.

Indexed as

AcupunctureChronic painGuided relaxationPragmatic effectiveness trialSickle cell diseaseSMART design

Identifiers

PMID36852100
PMCPMC9958255

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.