NCT07892456

Brief Summary

This study was designed to evaluate the effects of breathing meditation, accompanied by virtual reality (VR)-enhanced nature videos, on anxiety, comfort, pain, and physiological parameters in patients undergoing angiography. Prior to the procedure, pain levels in patients in both groups will be assessed using the Visual Analog Scale (VAS); the State Anxiety Inventory and the General Comfort Scale will be administered; and physiological parameters will be recorded. Patients in the intervention group will be fitted with VR headsets 5 minutes before the start of the angiography procedure and will undergo breathing meditation accompanied by nature videos. Patients in the control group, on the other hand, will receive routine standard nursing care and will not undergo the VR intervention. During the procedure, pain levels and physiological parameters will be assessed in patients from both groups. Following the angiography, the VAS, State Anxiety Inventory, and General Comfort Scale will be re-administered in both groups, and physiological parameters will be recorded again. By comparing the data obtained from both groups at the same measurement points, the effect of VR-supported nature video-guided breathing meditation on patients' anxiety, comfort, pain, and physiological parameters will be determined.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Oct 2026Dec 2026

Study Start

First participant enrolled

October 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

1 month

First QC Date

October 16, 2026

Last Update Submit

October 22, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • The Effect of Breathing Meditation and VR-Enhanced Nature Videos on Anxiety

    \*\*State Anxiety Inventory:\*\* The State Anxiety Inventory (STAI-I) will be used to assess patients' state anxiety before and after angiography. The inventory measures how individuals feel at a particular moment and consists of 20 items, each scored on a 4-point scale ranging from 1 to 4. Some items are reverse scored. Total scores range from 20 to 80, with higher scores indicating greater state anxiety. The inventory will be administered to patients before and after angiography to evaluate changes in anxiety levels following the intervention.

    2 month

  • The Effect of Breathing Meditation and VR-Enhanced Nature Videos on Pain

    \*\*Visual Analog Scale (VAS):\*\* The Visual Analog Scale (VAS) is a commonly used unidimensional tool for assessing pain intensity. It consists of a 10-cm (100-mm) line ranging from 0 (no pain) to 10 (worst imaginable pain). In this study, the VAS will be used to assess patients' pain levels before, during, and after angiography to evaluate the effect of breathing meditation combined with VR-enhanced nature videos on pain intensity.

    2 month

  • The Effect of Breathing Meditation and VR-Enhanced Nature Videos on Patient Comfort

    \*\*General Comfort Questionnaire (GCQ):\*\* The General Comfort Questionnaire will be used to assess patients' overall comfort levels before and after angiography. The questionnaire evaluates comfort across physical, psychospiritual, sociocultural, and environmental dimensions. The Turkish short form consists of 28 items and includes three subscales: relief (9 items), ease (9 items), and transcendence (10 items). Items are rated on a 6-point Likert scale, and negatively worded items are reverse-scored. The total score is divided by the number of items to obtain a mean score ranging from 1 to 6, with higher scores indicating greater comfort. The Turkish version demonstrated good internal consistency, with a Cronbach's alpha coefficient of 0.82. In this study, the questionnaire will be administered before and after angiography to evaluate the effect of breathing meditation combined with VR-enhanced nature videos on patients' comfort levels.

    2 month

  • The Effect of Breathing Meditation and VR-Enhanced Nature Videos on Blood Pressure

    Patients' blood pressure values will be recorded to evaluate the effect of breathing meditation combined with VR-enhanced nature videos on blood pressure during angiography. Blood pressure will be measured before, during, and after the angiography procedure in both the intervention and control groups.

    2 month

  • The Effect of Breathing Meditation and VR-Enhanced Nature Videos on Pulse Rate

    Patients' pulse rates will be recorded to evaluate the effect of breathing meditation combined with VR-enhanced nature videos on pulse rate during angiography. Pulse rate will be measured before, during, and after the angiography procedure in both the intervention and control groups.

    2 month

  • The Effect of Breathing Meditation and VR-Enhanced Nature Videos on Oxygen Saturation

    Patients' peripheral oxygen saturation (SpO₂) levels will be recorded to evaluate the effect of breathing meditation combined with VR-enhanced nature videos on oxygen saturation during angiography. Oxygen saturation will be measured before, during, and after the angiography procedure in both the intervention and control groups.

    2 month

Study Arms (2)

Breathing Meditation Combined with VR-Enhanced Nature Videos

EXPERIMENTAL

Before coronary angiography During coronary angiography After coronary angiography

Other: Breathing Meditation Combined with Virtual Reality-Enhanced Nature Videos

Standard care

NO INTERVENTION

Before coronary angiography During coronary angiography After coronary angiography

Interventions

Breathing meditation and nature video experience with a virtual reality headset

Breathing Meditation Combined with VR-Enhanced Nature Videos

Eligibility Criteria

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

You may qualify if:

  • Be between the ages of 18 and 65,
  • Be scheduled to undergo elective coronary angiography,
  • Be alert and able to communicate,
  • Have vision and hearing functions suitable for using the virtual reality application,
  • Cognitive functions must be at a level sufficient to respond to assessment scales,
  • Be able to read and understand Turkish and complete the research questionnaires,
  • Volunteer to participate in the study and sign the written Informed Consent Form.

You may not qualify if:

  • Scheduled to undergo emergency coronary angiography,
  • History of epilepsy,
  • Vertigo or severe balance disorder,
  • History of severe claustrophobia,
  • Use of anxiolytics or sedatives within the past 24 hours,
  • Severe vision or hearing loss that would prevent participation in the virtual reality application,
  • Being in a clinical condition that would prevent completion of the application during the study, or wishing to terminate the application during the session due to reasons such as dizziness or nausea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aybuke Gündengüne

Istanbul, İ̇stanbul, 34959, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Ferguson C, Davidson PM, Scott PJ, Jackson D, Hickman LD. Augmented reality, virtual reality and gaming: an integral part of nursing. Contemp Nurse. 2015;51(1):1-4. doi: 10.1080/10376178.2015.1130360. Epub 2016 Jan 14. No abstract available.

    PMID: 26678947BACKGROUND
  • Hayter M. Nurses' experiences of the effects of mindfulness training: a qualitative systematic review and meta-synthesis. Prof Inferm. 2021 Oct-Dec;74(4):256. doi: 10.7429/pi.2021.744256a.

    PMID: 35363964BACKGROUND
  • Plotzky C, Lindwedel U, Sorber M, Loessl B, Konig P, Kunze C, Kugler C, Meng M. Virtual reality simulations in nurse education: A systematic mapping review. Nurse Educ Today. 2021 Jun;101:104868. doi: 10.1016/j.nedt.2021.104868. Epub 2021 Mar 23.

    PMID: 33798987BACKGROUND
  • van der Riet P, Levett-Jones T, Aquino-Russell C. The effectiveness of mindfulness meditation for nurses and nursing students: An integrated literature review. Nurse Educ Today. 2018 Jun;65:201-211. doi: 10.1016/j.nedt.2018.03.018. Epub 2018 Mar 24.

    PMID: 29602138BACKGROUND
  • Soylu A, Soylu D. Comparison of Pain, Anxiety, and Comfort Level After Femoral or Transradial Angiography: A Descriptive Study. J Perianesth Nurs. 2025 Oct;40(5):1268-1274. doi: 10.1016/j.jopan.2025.01.018. Epub 2025 May 29.

    PMID: 40445154BACKGROUND

Study Officials

  • NİRAN ÇOBAN

    University of Yalova

    STUDY DIRECTOR

Central Study Contacts

Aybuke Gündengüne

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

October 16, 2026

First Posted

October 23, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 23, 2026

Record last verified: 2026-10

Locations