NCT07745946

Brief Summary

This study was conducted to determine the effect of virtual reality glasses use and breathing exercise application on anxiety levels in breast cancer patients undergoing chemotherapy treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable breast-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

Nursing, cancer, anxiety, chemotherapy, breathing exercise, virtual reality

Outcome Measures

Primary Outcomes (1)

  • Change in Anxiety Level

    Anxiety levels will be measured using a validated anxiety assessment tool ( State-Trait Anxiety Inventory \[STAI\], VAS, Vital Signs form before and after the intervention (virtual reality glasses, breathing exercise, or standard care) in each study group. The change in anxiety scores between baseline and post-intervention will be compared across the three groups.

    Baseline (before intervention) and immediately after intervention during the chemotherapy session

Study Arms (3)

Breathing Exercise Group

EXPERIMENTAL

Breathing exercise applied during chemotherapy sessions

Behavioral: Breathing exercise

Virtual Reality Glasses Group

EXPERIMENTAL

Use of virtual reality glasses during chemotherapy sessions

Behavioral: Virtual Reality Glasses

Control (Standard Care)

NO INTERVENTION

Interventions

Intervention 1: Breathing Exercise In this study, participants in the breathing exercise group will perform diaphragmatic (deep) breathing exercises during their chemotherapy sessions. Diaphragmatic breathing promotes deeper, more controlled respiration through effective use of the diaphragm muscle, producing a balancing effect on the autonomic nervous system, while slow rhythmic breathing supports relaxation by increasing heart rate variability. Participants will be guided by a nurse/researcher to perform the exercise for \[10 minutes\]

Also known as: Using Virtual Reality Glasses
Breathing Exercise Group

Intervention 2: Virtual Reality Glasses Participants in the virtual reality group will wear VR glasses displaying calming, distraction-based visual and auditory content during their chemotherapy infusion. This intervention aims to redirect attention away from the treatment process, thereby reducing perceived stress and anxiety. The VR session will be applied for \[10 minutes\]

Virtual Reality Glasses Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with breast cancer
  • Aged 18 years or older
  • Receiving treatment in the outpatient (day-case) chemotherapy unit
  • Voluntarily agreeing to participate in the study

You may not qualify if:

  • Having a respiratory-related disease
  • Having visual or hearing impairment
  • Having a communication problem
  • Having a diagnosis of psychiatric disease
  • Having a cancer diagnosis other than breast cancer
  • Receiving ice-cap therapy to prevent/reduce hair loss or cryotherapy for hand-foot neuropathy during chemotherapy treatment
  • Having vertigo or head-neck disorders
  • Patients hospitalized for their first cycle of chemotherapy treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasmsAnxiety Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The results were evaluated by a statistician independent of the study, without knowledge of the group assignments.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

March 15, 2025

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations