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Effects of VR and White Noise During Arthroscopy (VR/WN_ ART)

The Effect of Virtual Rain Forest and White Noise on Satisfaction, Tolerance, Comfort and Vital Signs During Arthroscopy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05992714
Acronym
(VR/WN_ ART)
Enrollment
93
Registered
2023-08-15
Start date
2023-09-30
Completion date
2023-11-30
Last updated
2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroscopic Surgical Procedures

Keywords

virtual reality, tolerance, satisfaction, comfort, white noise

Brief summary

Background: Today, arthroscopy is widely used in the diagnosis and of treatment intra-articular diseases. Arthroscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure especially spinal anesthesia. Along with physical discomfort during the procedure, it triggers, fear and anxiety in the patient. Purpose: To examine the effects of virtual rain forest and white noise on patient satisfaction, pain, comfort and vital signs in patients of arthroscopic knee surgery. Method: The population of the study consisted of all patients who applied to the Dicle University Hospital Orthopedics and Traumatology unit and were scheduled for arthroscopy in the operating room. Based on the sample size of Basak and Sahin's study using similar VR applications, 31 patients were determined for each group total 93 patients with 5% significance level and 80% power(13). G\*Power, version 3.0.10 was used for statistical power analysis. The study group of 93 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer- based Research Randomizer program. Before the arthroscopy procedure, the patients included in the study will be randomly divided into three groups: 31 rain forest video VR group, 31 white noise group and 31 control group. Data will be collected in the in the operating room on weekdays when the procedure is performed.

Interventions

Except for the preparation of the patient for the procedure, since the arthroscopy procedure takes approximately 60 minutes, 60-minute 360-degree VR video scenes will be watched using VR head device

Except for the preparation of the patient for the procedure, since the arthroscopy procedure takes approximately 60 minutes, 60-minute 360-degree VR video scenes will be watched using phone

Sponsors

Seher Tanrıverdi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Masking description

Double (Participant, Investigator)

Intervention model description

Parallel Assignment experimental model using randomized pretest and posttest with control group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

18 aged and over, Written and verbal consent to participate in the study, Being conscious (person, place and time orientation), Undergoing colonoscopy for the first time Spinal anesthesia applied, Meniscus surgery will be performed patients.

Exclusion criteria

Having vision, hearing and communication problems, Having any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.), Diagnosed with visual, auditory and / or balance disorders, General anesthesia applied patients.

Design outcomes

Primary

MeasureTime frameDescription
Patient Information Formthe fundamental characteristics of the patients will be filled in 10 minutes before the arthroscopy procedureThis form, which was created by the researcher; patients' age, gender, education level, marital status, employment status, income level, ASA level, chronic disease status, and previous surgery. It consists of a total of 9 questions
Visual Analogue Scale (VAS)Change from Baseline Visual Analogue Scale in 1 hourThis scale developed by Price (1983) will be used in the research to determine the level of tolerance, comfort and satisfaction. It is a scale in which the distance between the two ends with a minimum value of 0 on one end and a maximum value of 10 on the other end is measured with a 10 cm ruler. In this context; The patient is explained that there are two endpoints and that he is free to mark any place between them that fits the severity of his pain. The distance between the beginning of no comfort, tolerance and satisfaction and this point marked by the patient is measured and recorded in centimeters. It has been shown that the VAS is a valid tool for the measurement of psychological and health variables such as pain and satisfaction, which is widely used in clinical studies.
The Patient Observation FormChange from Baseline The Patient Observation Form in 1 hourThis form, which was created by the researcher, the vital signs (pulse, respiratory rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation values (SpO2) of the patients before and after the procedure were recorded the form.

Contacts

Primary ContactSeher Tanrıverdi, PhD
sehertanriverdi@artuklu.edu.tr+905469038921
Backup ContactHasan GENC, PhD
hasangenc4721@hotmail.com+905319887307

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026