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IRCT20200623047901N1 IRCT 2020-07-06 Mashhad University of Medical Sciences The effect of virtual reality on anxiety and pain in patients undergoing laparoscopic cholecystectomy The effect of applying virtual reality technology with two approaches of distraction and patient education on preoperative anxiety and postoperative pain in patients undergoing laparoscopic cholecystectomy 2020-07-10 anticipated 160 Complete https://irct.ir/trial/49167 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random sequencing using stata software and block method. Blocks of sizes 6, 9, and 12 will be used to increase unpredictability. The group will be packed in an envelope and the envelopes will be sorted and numbered according to the generated sequence. After obtaining the informed consent, the first available envelope will be opened for each client and his group will be identified. N/A Condition 1: Laparoscopic cholecystectomy patients with Cholelithiasis. Condition 2: Laparoscopic cholecystectomy patients with Cholecystitis. Intervention 1: Intervention Group: First Intervention Group (Patients of Virtual Reality Technology Group with Patient Training Approach): Before Surgery: (After admission of the patient in the surgical ward) glasses are placed for the patient. Containing animated content for 5 minutes that simulates the operating room environment, anesthesia, surgery, and wakefulness. After surgery: 4 hours after the operation, the glasses are placed on the patient, which contains animated content, simulating deep breathing, how to get out of bed, effective cough, and changing position for 5 minutes. Wear glasses to control pain at least twice before bedtime. Intervention 2: Intervention group: The intervention group 2 (for groups of virtual reality technology with the approach of distraction)Before surgery: Glasses containing a film with music and soothing images will be played for 5 minutes via a virtual reality headset.After surgery: 4 hours after surgery at least twice before bedtime, if the patient interferes with sleep after sleep, the same images will be played and executed for the patient by the glasses. Intervention 3: Control group: No specific action will be taken by the researcher, and the same hospital training, including educational pamphlets and face-to-face training, will be provided by the ward nurses for all patients. Yes - There is a plan to make this available What will be shared: All potential data can be shared after people have not been identified When: Start the access period 6 months after printing the results To whom: Only for researchers working in academic and scientific institutions Conditions: Health centers Where to obtain: Mashhad School of Nursing and Midwifery How to obtain: Immediately by visiting the library of Mashhad School of Nursing and Midwifery in person or online Comments:
public Abbasnia Fateme
Ibn Sina Ave,School of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 abbasniaf961@mums.ac.ir Mashhad University of Medical Sciences scientific Aghebati Nahid
Ibn Sina Ave, Faculty of Midwifery Nursing
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 1853 9775 aghebatin@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Uncomplicated cholelithiasis , Cholecystitis Lack of diagnosed mental disorder, lack of cognitive impairment, difficulty understanding the scale of pain No addiction to opioids or strong painkillers Lack of severe pain due to the nature of the disease (cancer) Fluency in Persian 18 years 60 years Both History of gastrointestinal surgery over the past two weeks History of vestibulocochlear abnormalities History of seizures and epilepsy K80 K81 Cholelithiasis Cholecystitis Other Other Other Intervention Group: First Intervention Group (Patients of Virtual Reality Technology Group with Patient Training Approach): Before Surgery: (After admission of the patient in the surgical ward) glasses are placed for the patient. Containing animated content for 5 minutes that simulates the operating room environment, anesthesia, surgery, and wakefulness. After surgery: 4 hours after the operation, the glasses are placed on the patient, which contains animated content, simulating deep breathing, how to get out of bed, effective cough, and changing position for 5 minutes. Wear glasses to control pain at least twice before bedtime Intervention group: The intervention group 2 (for groups of virtual reality technology with the approach of distraction)Before surgery: Glasses containing a film with music and soothing images will be played for 5 minutes via a virtual reality headset.After surgery: 4 hours after surgery at least twice before bedtime, if the patient interferes with sleep after sleep, the same images will be played and executed for the patient by the glasses. Control group: No specific action will be taken by the researcher, and the same hospital training, including educational pamphlets and face-to-face training, will be provided by the ward nurses for all patients. Postoperative pain scores measured in the McGill Pain Questionnaire and the Visual Analogue Scale. Timepoint: Measuring the amount of pain 4 hours after surgery (pre-intervention) and 15 minutes after intervention, every 4 hours to 24 hours after surgery. Method of measurement: McGill Pain Questionnaire, Visual Pain Measurement Scale. Anxiety score before surgery Spielberger questionnaire. Timepoint: Measure the amount of anxiety before surgery (before the intervention), 15 minutes after the intervention. Method of measurement: Through Spielberger's Anxiety Questionnaire. Mashhad University of Medical Sciences Approved 2020-04-28 Ethics Committee of Mashhad University of Medical Sciences Ibn Sina Ave, School of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)