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The Effect of Virtual Reality Glasses on Pain Level and Hemo-Dynamic Variables After Open Heart Surgery

Studies

Study First Submitted Date 2022-10-12
Study First Posted Date 2022-10-19
Last Update Posted Date 2023-03-15
Start Month Year January 15, 2024
Primary Completion Month Year November 15, 2024
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-03-15

Detailed Descriptions

Sequence: 20603319
Description The patient will be put on virtual reality glasses five minutes before the chest tube is removed. Afterwards, it will continue to be watched while the tube is taken and virtual reality glasses will be watched for another five minutes. Pain level and hemodynamic variables will be checked before, during, and 15 and 30 minutes after virtual reality glasses are watched. The participants in the control group will receive routine treatment and care, and their data will be collected at the same time as those in the study group. Hemodynamic variables will be monitored and recorded on the monitor. Virtual reality glasses application is a method without any side effects. During the research, any adverse condition (vision problem, nausea, dizziness, etc.) related to the use of virtual glasses will be observed by the researcher. Since virtual reality glasses will be used in another patient after being used on one patient, disinfection will be made in line with the company's recommendations, taking into account the pandemic conditions. Throughout the application, feedback will be received from the patients by the researchers.

Facilities

Sequence: 198888258
Name Turkey, Mersin University,
City Mersin
State Turkey/Mersin,Yenişehir
Zip 33343
Country Turkey

Conditions

Sequence: 51868777 Sequence: 51868778
Name Pain Name Hemodynamic Instability
Downcase Name pain Downcase Name hemodynamic instability

Id Information

Sequence: 39916983
Id Source org_study_id
Id Value MersinUnii

Countries

Sequence: 42313526
Name Turkey
Removed False

Design Groups

Sequence: 55293978 Sequence: 55293979
Group Type Experimental Group Type No Intervention
Title Virtual Reality application group Title Standard of care
Description Virtual reality glasses (VR Box Virtual Reality Headset 3D Vr Glasses V2.0 2020 model) compatible with the mobile phone (Lenovo P2a42) with the Android operating system will be worn and the patient will be watched (underwater world, open-air museum tours, beach trips and nature scenes) by patients for an average of 10 minutes during chest tube removal. Description Only standard care will be given and no application will be made.

Interventions

Sequence: 52187927
Intervention Type Other
Name virtual reality
Description Virtual reality glasses application is a method without any side effects. Patients will be treated for an average of 10 minutes. Data will be collected before, during, immediately after the application, at the 15th and 30th minutes.

Keywords

Sequence: 79376947 Sequence: 79376948 Sequence: 79376949 Sequence: 79376950
Name pain Name Virtual reality glasses Name open heart surgery Name hemodynamic
Downcase Name pain Downcase Name virtual reality glasses Downcase Name open heart surgery Downcase Name hemodynamic

Design Outcomes

Sequence: 176389378 Sequence: 176389379 Sequence: 176389380 Sequence: 176389381 Sequence: 176389382 Sequence: 176389383
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Pain evaluated using the Visual Analogue Scale Measure Systolic blood pressure Measure Diastolic blood pressure Measure Heart rate Measure Respiratory rate Measure Peripheral oxygen saturation
Time Frame Change from before implementation up to 30 minutes Time Frame Change from before implementation up to 30 minutes Time Frame Change from before implementation up to 30 minutes Time Frame Change from before implementation up to 30 minutes Time Frame Change from before implementation up to 30 minutes Time Frame Change from before implementation up to 30 minutes
Description Visual Analogue Scala has been developed to convert some values that cannot be measured numerically into numeric values. The VAS, which is a safe and easily applicable scale tool generally accepted in the world literature, consists of a 10 cm long line and there are subjective descriptive expressions at both ends of the scale (0 cm = none at all and 10 cm = highest degree.) Description Systolic blood pressure (SBP), mmHg Description Diastolic blood pressure (DBP), mmHg Description Beats per minute Description Lung breathing Description %, percentage of oxygenated hemoglobin in peripheral arterial blood

Sponsors

Sequence: 48037890
Agency Class OTHER
Lead Or Collaborator lead
Name Mersin University

Overall Officials

Sequence: 29108494 Sequence: 29108495 Sequence: 29108496 Sequence: 29108497
Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator
Name Gülay ALTUN UĞRAŞ, PhD Name Sevban ARSLAN, PhD Name Muaz GÜLŞEN, master Name Firdevs Ebru ÖZDEMİR, master
Affiliation Mersin University Affiliation Çukurova University Affiliation Çukurova University Affiliation Mersin University

Central Contacts

Sequence: 11946290
Contact Type primary
Name Tugba CAM YANIK, PhD
Phone +90 324 361 00 01
Email tugbacam@mersin.edu.tr
Phone Extension 14237
Role Contact

Design Group Interventions

Sequence: 67785408
Design Group Id 55293978
Intervention Id 52187927

Eligibilities

Sequence: 30587668
Gender All
Minimum Age 18 Years
Maximum Age 80 Years
Healthy Volunteers No
Criteria Inclusion Criteria: Agreeing to participate in the research (signing the Informed Consent Form), Conscious and cooperative, Stable hemodynamic status, Speaks and understands Turkish, Over 18 years old, On the 2nd and 3rd day after open heart surgery, Having chest tube, No sensitivity or trauma in the area (for the study group) where the virtual reality glasses will be applied, No active COVID-19 infection, Patients without any psychiatric diagnosis Exclusion Criteria: Agreeing to participate in the research (signing the Informed Consent Form), Not conscious, Not cooperative Unstable hemodynamic status, Speaks and understands Turkish, who are under the age of 18, On the 0th or 1st day after surgery, No chest tube, Has sensitivity or trauma in the area (for the study group) where the virtual reality Active COVID-19 infection, Patients with a psychiatric diagnosis
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253868930
Number Of Facilities 1
Registered In Calendar Year 2022
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30335624
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking Single
Intervention Model Description The study was planned as a prospective, two-armed (1:1), randomized controlled experimental study. This randomized controlled trial will be reported according to the CONSORT guidelines.
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28713830
Responsible Party Type Principal Investigator
Name Tugba CAM YANIK
Title Principal Investigator in the study/ Research Assistant at Surgical Nursing
Affiliation Mersin University