NCT07794709

Brief Summary

This randomized controlled trial was conducted to evaluate the effect of virtual reality-based breathing yoga applied before chest tube removal on pain and anxiety in patients after cardiac surgery. A total of 52 patients with chest tubes were randomly assigned to an intervention group (n=26) or a control group (n=26). Patients in the intervention group watched breathing yoga videos through virtual reality glasses for 15-20 minutes before chest tube removal, while patients in the control group received standard care. Pain was assessed using the Visual Analog Scale, and anxiety was assessed using the Spielberger State Anxiety Inventory. Pain and anxiety levels were evaluated before and after chest tube removal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 26, 2026

Last Update Submit

August 28, 2026

Conditions

Keywords

Virtual RealityBreathing YogaCardiac SurgeryPainAnxietyNonpharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • Change in State Anxiety Level

    State anxiety was assessed using the Spielberger State-Trait Anxiety Inventory-State subscale (STAI-I). The scale consists of 20 items and yields a total score ranging from 20 to 80, with higher scores indicating higher levels of state anxiety.

    30 minutes before chest tube removal and 15 minutes after chest tube removal

Secondary Outcomes (1)

  • Change in Pain Intensity

    30 minutes before chest tube removal and 15 minutes after chest tube removal

Study Arms (2)

1

EXPERIMENTAL

Virtual Reality-Based Breathing Yoga

Behavioral: Virtual Reality-Based Breathing Yoga

2

NO INTERVENTION

Participants received standard care before chest tube removal without the virtual reality-based breathing yoga intervention.

Interventions

Participants watched breathing yoga videos through virtual reality glasses for 15-20 minutes before chest tube removal. The intervention was provided in addition to standard postoperative care.

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-70 years
  • Underwent coronary artery bypass grafting or valve surgery
  • Willing to participate in the study
  • Mobilized and extubated on the second postoperative day
  • Able to communicate without cognitive, sensory, or verbal impairment
  • No diagnosed psychiatric disorder
  • No vertigo
  • No diagnosis of hypertension and not receiving antihypertensive treatment
  • Not receiving sedative or anxiolytic medication
  • No major intraoperative or postoperative complications, such as severe bleeding, nausea, or vomiting

You may not qualify if:

  • \- Remained intubated on the second postoperative day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to either the virtual reality-based breathing yoga group or the standard care control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assosciate Prof

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

August 10, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

August 31, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations