NCT05884047

Brief Summary

This study was conducted as a non-randomized control group experimental study to determine the effect of virtual reality glasses on vital signs and state anxiety levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

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

January 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

January 21, 2022

Last Update Submit

May 30, 2023

Conditions

Keywords

ChemotherapyVirtually RealityAnxietyNursing

Outcome Measures

Primary Outcomes (4)

  • Vital signs- Blood pressure

    Systolic blood pressure values

    first measurement just before the start of the chemotherapy infusion

  • Vital signs-pulse

    Pulse values

    first measurement just before the start of the chemotherapy infusion

  • Vital signs- Blood pressure

    Systolic blood pressure values

    the last measurement just after the end of the chemotherapy infusion

  • Vital signs-pulse

    Pulse values

    the last measurement just after the end of the chemotherapy infusion

Study Arms (2)

Virtual reality glasses

OTHER

In the research, Samsung Gear VR SM-R323 brand and model SG glasses provided by the researcher were used. Patients were offered four different options to watch as "Forest of Serenity", "Calm Place", "Happy Place", "Gala 360 Travel \& Relax". Forest of Serenity is a nature video consisting of bird sounds, colorful trees and flowers, and a clear lake where fish can be seen swimming in it. Calm Place is a relaxing video where cycles are shown 24 hours a day, where a person finds himself by the lake in the forest in snowy, rainy sunny weather. In Happy Place, one finds himself in a virtual camp environment where natural events such as dynamically changing weather, day-night cycles, and falling stars are experienced. Gala 360 Travel \& Relax is a Paris-Notre Dame museum tour video.

Device: Virtual Glasses

Scales

OTHER

Spielberger State Anxiety Inventory Vital Signs Follow-up Form

Device: Virtual Glasses

Interventions

In the research, Samsung Gear VR SM-R323 brand and model SG glasses provided by the researcher were used. Patients were offered four different options to watch as "Forest of Serenity", "Calm Place", "Happy Place", "Gala 360 Travel \& Relax". Forest of Serenity is a nature video consisting of bird sounds, colorful trees and flowers, and a clear lake where fish can be seen swimming in it. Calm Place is a relaxing video where cycles are shown 24 hours a day, where a person finds himself by the lake in the forest in snowy, rainy sunny weather. In Happy Place, one finds himself in a virtual camp environment where natural events such as dynamically changing weather, day-night cycles, and falling stars are experienced. Gala 360 Travel \& Relax is a Paris-Notre Dame museum tour video.

ScalesVirtual reality glasses

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with stage 1,2,3 cancer
  • Receive radiotherapy and chemotherapy for the first time
  • Volunteer patients who agreed to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahar İnkaya

Ankara, 060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • SEBILE OZDAG

    Hacettepe University Adult Oncology Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Semi-experimental
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

January 21, 2022

First Posted

June 1, 2023

Study Start

January 27, 2020

Primary Completion

April 1, 2020

Study Completion

June 1, 2020

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations