Evidence map›Paper›PMID 34674737›Full record

ArticleTrials2021

Evaluating the potential of respiratory-sinus-arrhythmia biofeedback for reducing physiological stress in adolescents with autism: study protocol for a randomized controlled trial.

Anoushka Thoen, Jean Steyaert, Kaat Alaerts, Tine Van Damme

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04628715 (Evaluating the Potential of Respiratory-sinus-arrhythmia Biofeedback for Reducing Physiological Stress in Adolescents With Autism), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 27% 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.

NCT04628715 naterminatednot on this map

Evaluating the Potential of Respiratory-sinus-arrhythmia Biofeedback for Reducing Physiological Stress in Adolescents With Autism: a Randomized Controlled Study

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2020 to 2022Enrolled63ConditionsAutism Spectrum DisorderArmsRSA biofeedback
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
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

4 authors at 1 institution in 1 country.

Anoushka ThoenDepartment of Rehabilitation Sciences, Research Group for Adapted Physical Activity and Psychomotor Rehabilitation, KU Leuven, Leuven, Belgium. anoushka.thoen@kuleuven.be.ORCID http://orcid.org/0000-0001-6408-220X
Jean SteyaertLeuven Autism Research (LAuRes), KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0003-2512-4694
Kaat AlaertsLeuven Autism Research (LAuRes), KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0001-8665-6374
Tine Van DammeDepartment of Rehabilitation Sciences, Research Group for Adapted Physical Activity and Psychomotor Rehabilitation, KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0002-8197-6704
KU Leuven · BE

Funding

Marguerite-Marie Delacroix Foundation (BE) GV/B-363
6 · The paper itself

Abstract

backgroundPrior evidence points towards lower cardiac vagal modulation in individuals with autism spectrum disorder (ASD) as compared to control groups. A cross-sectional phase in this study will gather more evidence concerning this topic. A longitudinal phase will explore the efficacy of a biofeedback intervention based on respiratory sinus arrhythmia (RSA) in adolescents with ASD. Finally, a feasibility study will focus on a non-supervised RSA biofeedback intervention in this population.

methodsThe cross-sectional phase includes the comparison of adolescents with ASD (n=38) and age- and gender-matched typically developing peers. A standardized assessment will be used which contains physiological, cortisol, and behavioral measurements. The longitudinal phase contains a randomized, single-blinded, and sham-controlled design to determine the efficacy of supervised RSA biofeedback in adolescents with ASD (n=128). A follow-up phase of 5 weeks is included to evaluate the presence of retention effects. During the latter, a feasibility study will focus on a non-supervised intervention (n=64). Assessments as described previously are scheduled after the intervention and the follow-up phase. DISCUSSION: First, more conclusive evidence will be provided for the presence of lower cardiac vagal modulation in adolescents with ASD as well as the association between these lower values and physiological and behavioral indices. Second, the supervised intervention in adolescents with ASD is hypothesized to upregulate this cardiac vagal modulation and positively change behavioral and physiological parameters. Third, evidence regarding the feasibility and acceptability of a non-supervised intervention may open novel avenues for home-based interventions in this population.

trial registrationClinicalTrials.gov NCT04628715 . Registered on 13 November 2020.

Indexed as

Autism Spectrum DisorderAutistic DisorderRespiratory Sinus ArrhythmiaAdolescentArrhythmias, CardiacBiofeedback, PsychologyCross-Sectional StudiesHumansRandomized Controlled Trials as TopicStress, PhysiologicalAutism spectrum disorderCardiac vagal modulationRandomized controlled trialRSA biofeedback

Identifiers

PMID34674737
PMCPMC8530505
OpenAlexW3134787703

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.