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Clinical Trials/NCT05992714
NCT05992714Not yet recruitingNot Applicable

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

Seher Tanrıverdi0 sites93 target enrollmentStarted: September 30, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
93
Primary Endpoint
Patient Information Form

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Masking Description

Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Patient Information Form

Time Frame: the fundamental characteristics of the patients will be filled in 10 minutes before the arthroscopy procedure

This 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

The Patient Observation Form

Time Frame: Change from Baseline The Patient Observation Form in 1 hour

This 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.

Visual Analogue Scale (VAS)

Time Frame: Change from Baseline Visual Analogue Scale in 1 hour

This 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Seher Tanrıverdi
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Seher Tanrıverdi

Asistant Professor

Mardin Artuklu University

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