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IRCT20251121068066N7 IRCT 2026-01-13 Shahid Rajaee Cardiovascular Research and Treatment Center The Effect of Thought Diversion Intervention using Virtual Reality Glasses on Morphine Consumption and Anxiety in Patients After Cardiac Surgery: A Randomized Clinical Trial The Effect of Thought Diversion Intervention using Virtual Reality Glasses on Morphine Consumption and Anxiety in Patients After Cardiac Surgery: A Randomized Clinical Trial 2026-01-30 anticipated 56 Complete https://irct.ir/trial/88289 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be conducted continuously and randomly. Eligible patients will be assigned to two groups: the virtual reality group (Group A) and the control group (Group B) using a randomized block allocation method. The randomization list will only be accessible to the person responsible for educating the patients and will not be known to other personnel, including the surgeon, anesthesiologist, data collectors, or statisticians, Blinding description: This study will use single-blind or partial blinding, where the surgeon, anesthesiologist, data collectors, and statisticians are blinded to the group assignment. The patient educator is the only individual who will have access to the randomization list. Although patients will be aware of their assigned group, the same anesthetic drug protocol will be applied to both groups to minimize potential confounding factors during the assessment. 3 Postoperative anxiety. Intervention 1: Intervention group: Patients will receive two virtual reality intervention sessions in the intensive care unit, starting 24 hours after endotracheal extubation. Each session will last 15 minutes, with a 6-hour interval between sessions. During the intervention, patients will lie in a quiet environment and use virtual reality goggles displaying 3D natural landscapes (e.g., sea and beach) accompanied by relaxing natural sounds (e.g., wind, waves, birds) via headphones. The anesthesia and PCA protocols will be identical to those used in the control group. Intervention 2: Control group: Patients will receive routine daily care in the intensive care unit without any additional intervention. The anesthesia and PCA protocols will be the same as those used in the intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available
public Hamed Jamshidi
Unit 5, No. 12, Mirzaei Street, Golshahr, Karaj
Karaj Iran (Islamic Republic of) 3198766571 +98 26 3464 2335 info@rhi.ac.ir Shahid Rajaee Cardiovascular Educational, Research and Treatment Institute scientific Dr. Yasmin Chaibakh
Shahid Rajaee Cardiovascular Educational, Research, and Treatment Institute, Corner of Niayesh, Next to Mellat Park, Vali Asr Street (Aj), Tehran
Tehran Iran (Islamic Republic of) ۱۹۹۵۶۱۴۳۳۱ +98 911 150 0868 yasmin.chaibakhsh@gmail.com Shahid Rajaee Cardiovascular Educational, Research and Treatment Institute Iran (Islamic Republic of) Patients admitted to the intensive care unit following heart valve surgery. Age between 18 and 65 years. Conscious and able to communicate verbally. Fluent in Persian. Willingness to cooperate in the study. No chronic pain prior to surgery. No speech, hearing, or vision impairments. No psychological diseases. No claustrophobia or acrophobia. 18 years 65 years Both Unwillingness to continue cooperation. Clinical deterioration or decreased level of consciousness. Death during the study. Postoperative delirium. Patients undergoing intraaortic balloon pump. Surgery canceled or postponed. Adrenal gland disorder. Substance abuse or addiction. Uncooperative behavior interfering with study procedures. F41.9 Anxiety disorder, unspecified Treatment - Other N/A Intervention group: Patients will receive two virtual reality intervention sessions in the intensive care unit, starting 24 hours after endotracheal extubation. Each session will last 15 minutes, with a 6-hour interval between sessions. During the intervention, patients will lie in a quiet environment and use virtual reality goggles displaying 3D natural landscapes (e.g., sea and beach) accompanied by relaxing natural sounds (e.g., wind, waves, birds) via headphones. The anesthesia and PCA protocols will be identical to those used in the control group. Control group: Patients will receive routine daily care in the intensive care unit without any additional intervention. The anesthesia and PCA protocols will be the same as those used in the intervention group. Morphine Consumption: The amount of morphine consumed by the patient, recorded via the PCA (Patient-Controlled Analgesia) system, measured and compared before the first and second interventions. Timepoint: Before the first intervention and before the second intervention (with a 6-hour interval). Method of measurement: The dose taken via the Patient-Controlled Analgesia (PCA) device will be recorded by the researcher or staff at the designated time points. Anxiety Level: Anxiety is defined as a state of intense and persistent worry or fear about potential future events. It is a common psychological response to changes and new experiences, often characterized by heightened nervousness and apprehension. Timepoint: Anxiety will be assessed at three time points: before the intervention, immediately after the first intervention, and immediately after the second intervention. Method of measurement: Anxiety levels were assessed using the Situational Anxiety Inventory (STAI-Y1), consisting of 20 items on a 4-point Likert scale (from very low to very high). The total score ranges from 20 to 80. Pain Level: Pain is defined as “an unpleasant sensory and emotional experience associated with or resembling actual or potential tissue damage,” where sensory perceptions, emotional, and cognitive processes interact in a complex manner. Timepoint: Pain levels will be assessed at three time points: before the intervention, immediately after the first intervention, and immediately after the second intervention. Method of measurement: Pain intensity is measured using a Visual Analog Scale (VAS), represented by a 100-mm line, with scores ranging from 0 (no pain) to 100 (worst possible pain). Shahid Rajaee Cardiovascular Research and Treatment Center Approved 2025-12-01 Specialized Committee on Ethics in Biomedical Research Shahid Rajaee Cardiovascular Educational, Research, and Treatment Institute, Corner of Niayesh, Next to Mellat Park, Vali Asr Street (Aj), Tehran Tehran Tehran Iran (Islamic Republic of)