Evidence map›Paper›PMID 39414288›Full record

ArticleBMJ open2024

Study protocol for a multicentre randomised controlled trial evaluating the efficacy of an online yoga intervention in high-grade glioma patients and their caregivers: the YINOTA-O-trial.

Antonia Rabe, Almuth Friederike Keßler, Carsten Hagemann, Jörg Schubert, Elisabeth Jentschke

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Article
  2. 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

5 authors.

Antonia RabeComprehensive Cancer Center Mainfranken, University Hospital Würzburg, Würzburg, Germany.ORCID 0000-0002-0511-5371
Almuth Friederike KeßlerDepartment of Neurosurgery, Section Experimental Neurosurgery, University Hospital Würzburg, Würzburg, Germany.
Carsten HagemannDepartment of Neurosurgery, Section Experimental Neurosurgery, University Hospital Würzburg, Würzburg, Germany.
Jörg SchubertInternal Medicine Center, Central Laboratory, University Hospital Würzburg, Würzburg, Germany.
Elisabeth JentschkeComprehensive Cancer Center Mainfranken, University Hospital Würzburg, Würzburg, Germany Jentschke_E@ukw.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHigh-grade glioma patients and their caregivers often suffer from distress and a lower quality of life. Results from studies with patients with mixed cancer entities suggest that yoga can be an effective support. However, it is unclear whether this also applies to high-grade glioma patients and their caregivers. This study aims to investigate the effects of mindfulness-based online yoga for patients and their caregivers on emotional distress, quality of life and stress-associated physiological parameters compared with a waiting control group (WCG). METHODS & ANALYSIS: The study is designed as a multicentre randomised controlled trial. Adult glioma patients (central nervous system WHO grades 3 and 4) and their caregivers will be recruited. Examined yoga instructors deliver the intervention (1 hour per week) in a synchronous format over 8 weeks via video conferencing. The WCG will receive standard care during the 8-week waiting period. Data will be collected before and after the end of the intervention and another 3 months later using questionnaires as well as blood serum and hair samples to evaluate biochemical stress parameters. Primary outcome is self-reported generalised anxiety and secondary outcomes are self-reported fear of progression, depression and quality of life as well as brain-derived neurotrophic factor (BDNF), dehydroepiandrosterone (DHEA)/dehydroepiandrosterone sulfate (DHEAS), ferritin and hair cortisol. We hypothesise better outcomes in the intervention group compared with the WCG at all measurement points. 70 patients and 70 caregivers will be recruited consecutively. Primary endpoints are significant effect detections in the Generalised Anxiety Disorder scale-7 of patients and caregivers at the end of the intervention. Analyses of covariance will be performed to analyse the treatment effects. ETHICS AND DISSEMINATION: The Ethics Committee of the University of Würzburg approved the YINOTA-O ( TRIAL REGISTRATION NUMBER: German Clinical Trials Register No. DRKS00029554.

Indexed as

CaregiversGliomaQuality of LifeYogaAdultBrain NeoplasmsFemaleHumansMaleMindfulnessMulticenter Studies as TopicRandomized Controlled Trials as TopicStress, PsychologicalAnxiety disordersDepression and mood disordersHead and neck tumoursQuality of Life

Identifiers

PMID39414288
PMCPMC11487817

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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.