xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05992714</url>
    </required_header>
    <id_info>
      <org_study_id>vr/white noise</org_study_id>
      <nct_id>NCT05992714</nct_id>
    </id_info>
    <brief_title>Effects of VR and White Noise During Arthroscopy (VR/WN_ ART)</brief_title>
    <acronym>(VR/WN_ ART)</acronym>
    <official_title>The Effect of Virtual Rain Forest and White Noise on Satisfaction, Tolerance, Comfort and Vital Signs During Arthroscopy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seher Tanrıverdi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mardin Artuklu University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: Today, arthroscopy is widely used in the diagnosis and of treatment&#xD;
        intra-articular diseases. Arthroscopy is considered a procedure that disturbs the patient's&#xD;
        comfort because it is a very invasive and painful procedure especially spinal anesthesia.&#xD;
        Along with physical discomfort during the procedure, it triggers, fear and anxiety in the&#xD;
        patient.&#xD;
  &#xD;
        Purpose: To examine the effects of virtual rain forest and white noise on patient&#xD;
        satisfaction, pain, comfort and vital signs in patients of arthroscopic knee surgery.&#xD;
  &#xD;
        Method: The population of the study consisted of all patients who applied to the Dicle&#xD;
        University Hospital Orthopedics and Traumatology unit and were scheduled for arthroscopy in&#xD;
        the operating room. Based on the sample size of Basak and Sahin's study using similar VR&#xD;
        applications, 31 patients were determined for each group total 93 patients with 5%&#xD;
        significance level and 80% power(13). G*Power, version 3.0.10 was used for statistical power&#xD;
        analysis. The study group of 93 people to participate in the study will be divided into three&#xD;
        equal groups in accordance with the random numbers table obtained the computer- based&#xD;
        Research Randomizer program. Before the arthroscopy procedure, the patients included in the&#xD;
        study will be randomly divided into three groups: 31 rain forest video VR group, 31 white&#xD;
        noise group and 31 control group. Data will be collected in the in the operating room on&#xD;
        weekdays when the procedure is performed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel Assignment experimental model using randomized pretest and posttest with control group</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Double (Participant, Investigator)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Information Form</measure>
      <time_frame>the fundamental characteristics of the patients will be filled in 10 minutes before the arthroscopy procedure</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>Change from Baseline Visual Analogue Scale in 1 hour</time_frame>
      <description>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.&#xD;
  The distance between the beginning of &quot;no comfort, tolerance and satisfaction&quot; 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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Patient Observation Form</measure>
      <time_frame>Change from Baseline The Patient Observation Form in 1 hour</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">93</enrollment>
    <condition>Arthroscopic Surgical Procedures</condition>
    <arm_group>
      <arm_group_label>Virtual Reality Glasses</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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</description>
    </arm_group>
    <arm_group>
      <arm_group_label>White Noise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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 listened using phone</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients of the control group, will not receive any intervention except for applied routine hospital arthroscopy surgery procedures</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Virtual Reality Glasses group</intervention_name>
      <description>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</description>
      <arm_group_label>Virtual Reality Glasses</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>white noise group</intervention_name>
      <description>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</description>
      <arm_group_label>White Noise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          18 aged and over, Written and verbal consent to participate in the study, Being conscious&#xD;
          (person, place and time orientation), Undergoing colonoscopy for the first time Spinal&#xD;
          anesthesia applied, Meniscus surgery will be performed patients.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Having vision, hearing and communication problems, Having any psychiatric and&#xD;
          cognitive/mental mental health problems, disease (dementia, etc.), Diagnosed with visual,&#xD;
          auditory and / or balance disorders, General anesthesia applied patients.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Seher Tanrıverdi, PhD</last_name>
      <phone>+905469038921</phone>
      <email>sehertanriverdi@artuklu.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hasan GENC, PhD</last_name>
      <phone>+905319887307</phone>
      <email>hasangenc4721@hotmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Sahin G, Basak T. The Effects of Intraoperative Progressive Muscle Relaxation and Virtual Reality Application on Anxiety, Vital Signs, and Satisfaction: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Jun;35(3):269-276. doi: 10.1016/j.jopan.2019.11.002. Epub 2020 Mar 4.</citation>
      <PMID>32146074</PMID>
    </reference>
    <reference>
      <citation>Celebi D, Yilmaz E, Sahin ST, Baydur H. The effect of music therapy during colonoscopy on pain, anxiety and patient comfort: A randomized controlled trial. Complement Ther Clin Pract. 2020 Feb;38:101084. doi: 10.1016/j.ctcp.2019.101084. Epub 2019 Dec 23.</citation>
      <PMID>32056820</PMID>
    </reference>
    <reference>
      <citation>Huang MY, Scharf S, Chan PY. Effects of immersive virtual reality therapy on intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia: A randomized controlled trial. PLoS One. 2020 Feb 24;15(2):e0229320. doi: 10.1371/journal.pone.0229320. eCollection 2020.</citation>
      <PMID>32092098</PMID>
    </reference>
    <reference>
      <citation>Umezawa S, Higurashi T, Uchiyama S, Sakai E, Ohkubo H, Endo H, Nonaka T, Nakajima A. Visual distraction alone for the improvement of colonoscopy-related pain and satisfaction. World J Gastroenterol. 2015 Apr 21;21(15):4707-14. doi: 10.3748/wjg.v21.i15.4707.</citation>
      <PMID>25914482</PMID>
    </reference>
    <reference>
      <citation>Veldhuijzen G, Klaassen NJM, Van Wezel RJA, Drenth JPH, Van Esch AA. Virtual reality distraction for patients to relieve pain and discomfort during colonoscopy. Endosc Int Open. 2020 Jul;8(7):E959-E966. doi: 10.1055/a-1178-9289. Epub 2020 Jun 30.</citation>
      <PMID>32626819</PMID>
    </reference>
    <reference>
      <citation>Ilkkaya NK, Ustun FE, Sener EB, Kaya C, Ustun YB, Koksal E, Kocamanoglu IS, Ozkan F. The effects of music, white noise, and ambient noise on sedation and anxiety in patients under spinal anesthesia during surgery. J Perianesth Nurs. 2014 Oct;29(5):418-26. doi: 10.1016/j.jopan.2014.05.008.</citation>
      <PMID>25261145</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Mardin Artuklu University</investigator_affiliation>
      <investigator_full_name>Seher Tanrıverdi</investigator_full_name>
      <investigator_title>Asistant Professor</investigator_title>
    </responsible_party>
    <keyword>virtual reality</keyword>
    <keyword>tolerance</keyword>
    <keyword>satisfaction</keyword>
    <keyword>comfort</keyword>
    <keyword>white noise</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Undecided all IPD that underlie results in a publication</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05992714
  org study id: vr/white noise
  nct id: NCT05992714
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel Assignment experimental model using randomized pretest and posttest with control group
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  masking description: Double (Participant, Investigator)
  measure: Patient Information Form
  time frame: the fundamental characteristics of the patients will be filled in 10 minutes before the arthroscopy procedure
  description: 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
  measure: Visual Analogue Scale (VAS)
  time frame: Change from Baseline Visual Analogue Scale in 1 hour
  description: 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.
  measure: The Patient Observation Form
  time frame: Change from Baseline The Patient Observation Form in 1 hour
  description: 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.
  arm group label: Virtual Reality Glasses
  arm group type: Experimental
  description: 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
  arm group label: White Noise
  arm group type: Experimental
  description: 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 listened using phone
  arm group label: control group
  arm group type: No Intervention
  description: Patients of the control group, will not receive any intervention except for applied routine hospital arthroscopy surgery procedures
  intervention type: Device
  intervention name: Virtual Reality Glasses group
  description: 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
  arm group label: Virtual Reality Glasses
  intervention type: Device
  intervention name: white noise group
  description: 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
  arm group label: White Noise
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Seher Tanrıverdi, PhD
  phone: +905469038921
  email: sehertanriverdi@artuklu.edu.tr
  last name: Hasan GENC, PhD
  phone: +905319887307
  email: hasangenc4721@hotmail.com
  citation: Sahin G, Basak T. The Effects of Intraoperative Progressive Muscle Relaxation and Virtual Reality Application on Anxiety, Vital Signs, and Satisfaction: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Jun;35(3):269-276. doi: 10.1016/j.jopan.2019.11.002. Epub 2020 Mar 4.
  PMID: 32146074
  citation: Celebi D, Yilmaz E, Sahin ST, Baydur H. The effect of music therapy during colonoscopy on pain, anxiety and patient comfort: A randomized controlled trial. Complement Ther Clin Pract. 2020 Feb;38:101084. doi: 10.1016/j.ctcp.2019.101084. Epub 2019 Dec 23.
  PMID: 32056820
  citation: Huang MY, Scharf S, Chan PY. Effects of immersive virtual reality therapy on intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia: A randomized controlled trial. PLoS One. 2020 Feb 24;15(2):e0229320. doi: 10.1371/journal.pone.0229320. eCollection 2020.
  PMID: 32092098
  citation: Umezawa S, Higurashi T, Uchiyama S, Sakai E, Ohkubo H, Endo H, Nonaka T, Nakajima A. Visual distraction alone for the improvement of colonoscopy-related pain and satisfaction. World J Gastroenterol. 2015 Apr 21;21(15):4707-14. doi: 10.3748/wjg.v21.i15.4707.
  PMID: 25914482
  citation: Veldhuijzen G, Klaassen NJM, Van Wezel RJA, Drenth JPH, Van Esch AA. Virtual reality distraction for patients to relieve pain and discomfort during colonoscopy. Endosc Int Open. 2020 Jul;8(7):E959-E966. doi: 10.1055/a-1178-9289. Epub 2020 Jun 30.
  PMID: 32626819
  citation: Ilkkaya NK, Ustun FE, Sener EB, Kaya C, Ustun YB, Koksal E, Kocamanoglu IS, Ozkan F. The effects of music, white noise, and ambient noise on sedation and anxiety in patients under spinal anesthesia during surgery. J Perianesth Nurs. 2014 Oct;29(5):418-26. doi: 10.1016/j.jopan.2014.05.008.
  PMID: 25261145
  responsible party type: Sponsor-Investigator
  investigator affiliation: Mardin Artuklu University
  investigator full name: Seher Tanrıverdi
  investigator title: Asistant Professor
  sharing ipd: Undecided
  ipd description: Undecided all IPD that underlie results in a publication