Evidence map›Paper›PMID 36600369›Full record

ArticleBMJ open2022

Biofeedback Enabled CALM (BeCALM)-the feasibility of biofeedback on procedural anxiety during radiation therapy: study protocol for a pilot randomised controlled trial.

Erin Forbes, Kerrie Clover, Amanda L Baker, Kristen Louise McCarter, Sharon Oultram, Mahesh Kumar, Chris Wratten, Minh Thi Tieu, Jodie Nixon, Ben Britton

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 39% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

10 authors at 5 institutions in 4 countries.

Erin ForbesSchool of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia Erin.Forbes@newcastle.edu.au.ORCID 0000-0003-0073-4621
Kerrie CloverSchool of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Amanda L BakerSchool of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Kristen Louise McCarterSchool of Psychological Sciences, College of Science, Engineering and Environment, The University of Newcastle, Callaghan, New South Wales, Australia.ORCID 0000-0002-2638-6381
Sharon OultramRadiation Oncology Department, Calvary Mater Newcastle, Waratah, New South Wales, Australia.
Mahesh KumarSchool of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Chris WrattenSchool of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Minh Thi TieuSchool of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Jodie NixonSchool of Health and Rehabilitation Sciences, The University of Queensland, Saint Lucia, Queensland, Australia.
Ben BrittonMental Health Services, Hunter New England Health, New Lambton, New South Wales, Australia.
Radiation Oncology Associates · USUniversity of Newcastle Australia · AUCalvary Mater Newcastle Hospital · AUMental Health Services · DKThe University of Queensland · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients undergoing treatment for cancer who require radiation therapy (RT) report anxiety specifically relating to the RT procedure. Procedural anxiety can be detrimental to treatment delivery, causing disruptions to treatment sessions, or treatment avoidance. Acute procedural anxiety is most commonly managed with anxiolytic medication. There is a need for effective, non-pharmacological interventions for patients not suitable for, or who prefer to avoid, anxiolytic medication. The primary objectives of this pilot trial are to evaluate the: (1) feasibility of conducting the Biofeedback Enabled CALM (BeCALM) intervention during RT treatment sessions; (2) acceptability of the BeCALM intervention among patients; and (3) acceptability of the BeCALM intervention among radiation therapists. The secondary objective of this pilot trial is to examine the potential effectiveness of the BeCALM intervention delivered by radiation therapists to reduce procedural anxiety during RT. METHODS AND ANALYSIS: This is a pilot randomised controlled trial. A researcher will recruit adult patients with cancer (3-month recruitment period) scheduled to undergo RT and meeting eligibility criteria for procedural anxiety at the Calvary Mater Hospital, Newcastle (NSW), Australia. Participants will be randomly assigned to receive treatment as usual or the BeCALM intervention (biofeedback plus brief breathing techniques). The primary outcomes are feasibility (measured by recruitment, retention rates and percentage of treatment sessions in which the intervention was successfully delivered); radiation therapists perceived feasibility and acceptability (survey responses); and patient perceived acceptability (survey responses). Secondary outcome is potential effectiveness of the intervention (as measured by the State Trait Anxiety Inventory-State subscale; the Distress Thermometer; and an analysis of treatment duration). ETHICS AND DISSEMINATION: The study protocol has received approval from Hunter New England Health Human Research Ethics Committee (2021/ETH11356). The results will be disseminated via peer-reviewed publications, as well as presentation at relevant conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001742864.

Indexed as

Anti-Anxiety AgentsAdultAnxietyBiofeedback, PsychologyFeasibility StudiesHumansPilot ProjectsRandomized Controlled Trials as TopicAnti-Anxiety Agentsanxiety disordersradiation oncologyradiotherapy

Identifiers

PMID36600369
PMCPMC9730381
OpenAlexW4310809567

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.