Evidence map›Paper›PMID 40539943›Full record

Trial reportJournal of medical Internet research2025

Impact of Virtual Reality-Based Biofeedback on Sleep Quality Among Individuals With Depressive Symptoms, Anxiety Symptoms, or Both: 4-Week Randomized Controlled Study.

Sisu Seong, Hyewon Kim, Yaehee Cho, Min-Ji Kim, Ka Ram Park, Jooeun Choi, Seonah Lee, Dong Jun Kim, Seog Ju Kim, Hong Jin Jeon

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Digital Psychiatry with Virtual Reality and Augmented Reality: Recent Advances and Limitations.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2026
    Review
  3. Article
  4. 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

10 authors.

Sisu SeongDepartment of Medical Device Management and Research, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Republic of Korea.ORCID http://orcid.org/0009-0005-7313-9294
Hyewon KimDepartment of Psychiatry, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.ORCID http://orcid.org/0000-0001-5665-8280
Yaehee ChoDepartment of Psychiatry, Depression Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea, 821034103586.ORCID http://orcid.org/0000-0001-7577-4842
Min-Ji KimBiomedical Statistics Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0001-5102-0536
Ka Ram ParkDepartment of Medical Device Management and Research, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Republic of Korea.ORCID http://orcid.org/0009-0009-3959-1198
Jooeun ChoiDepartment of Medical Device Management and Research, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Republic of Korea.ORCID http://orcid.org/0009-0009-5606-4189
Seonah LeeDepartment of Psychiatry, Depression Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea, 821034103586.ORCID http://orcid.org/0009-0006-8034-9174
Dong Jun KimMeditrix Co., Ltd., Seoul, Republic of Korea.ORCID http://orcid.org/0009-0002-1117-210X
Seog Ju KimDepartment of Psychiatry, Depression Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea, 821034103586.ORCID http://orcid.org/0000-0003-2467-5451
Hong Jin JeonDepartment of Medical Device Management and Research, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-6126-542X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Use of virtual reality (VR)-based biofeedback (BF) represents an emerging nonpharmacological intervention for enhancing sleep quality in individuals exhibiting depressive symptoms, anxiety symptoms, or both. However, empirical evidence regarding its efficacy in addressing sleep disturbances remains limited and inconclusive. Objective: This 3-arm randomized controlled trial aimed (1) to compare the efficacy of VR-based BF with conventional BF in improving sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI), among individuals with depressive symptoms, anxiety symptoms, or both (DAS); (2) to examine the effects of VR-based BF in a demographically similar healthy control (HC) group; and (3) to evaluate between-group differences in sleep quality improvements at the 4-week follow-up. Methods: Participants scoring ≥10 on the Patient Health Questionnaire-9 or ≥9 on the Panic Disorder Severity Scale were allocated to a group with DAS while others were assigned to a HC group. The DAS group was subsequently randomized into VR-based BF or conventional BF interventions with a therapist. All participants attended sessions at weeks 0, 2, and 4, completing assessments including the Montgomery-Asberg Depression Rating Scale, State-Trait Anxiety Inventory, and Visual Analog Scale in interviews. The PSQI was administered at baseline and postintervention to evaluate alterations in sleep quality over a 4-week period. Results: A total of 118 participants were randomized into a VR-based BF group (DAS/VR, n=40) or a conventional BF group (DAS/BF, n=38), and a control group (HC/VR, n=40) received VR-based BF. Sleep disturbance scores of both DAS/VR and DAS/BF groups had significant improvements (mean reductions of -0.58, SD 0.75 and -0.66, SD 0.75, respectively) compared to those preintervention, showing no significant difference after adjusting for age and sex (P=.49). The DAS/VR group had a greater improvement in sleep disturbance (mean -0.08, SD 0.53; P=0.0014) than the HC/VR group. Global PSQI scores in both DAS/VR and DAS/BF groups improved compared to those preintervention, showing decreases by -2.50 (SD 2.89) and -3.39 (SD 2.80), respectively. The difference between the 2 groups was not statistically significant (P=.14). The Global PSQI score in the DAS/VR group showed significant improvement (-0.95, SD 2.09; P=.01) compared to that in the HC/VR group. Conclusions: This study provides evidence that both VR-based BF and conventional BF with a therapist are efficacious psychological interventions for enhancing sleep quality in individuals with depressive symptoms, anxiety symptoms, or both, with no significant differences observed between these 2 approaches. Both interventions showed significant improvements compared to baseline measurements. These findings suggest potential applications of these interventions in clinical settings to improve sleep quality and mental well-being.

Indexed as

AnxietyBiofeedback, PsychologyDepressionSleep QualityVirtual RealityAdultFemaleHumansMaleMiddle AgedbiofeedbackdepressionPittsburgh Sleep Quality IndexPSQIsleep qualityvirtual reality

Identifiers

PMID40539943
PMCPMC12204043

What OpenQuestion holds

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LicenceCC BY
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.