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IRCT20250407065237N1 IRCT 2025-04-12 Babol University of Medical Sciences Effect of virtual reality and rhythmic breathing on patients prior to gastrointestinal endoscopy Comparing the effect of virtual reality and rhythmic breathing on patient’s Situational anxiety, fear and physiological variables prior to upper gastrointestinal endoscopy 2025-04-30 anticipated 60 Complete https://irct.ir/trial/82771 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Researchers will select participants in this study based on the inclusion criteria: Randomization will be conducted using a web-based tool, with 60 subjects independently randomized into 4 equally sized blocks. The generated sequences will be recorded using Randomizer software, and the assigned codes will be placed in opaque envelopes. Upon the enrollment of each new participant, the envelope will be opened to determine the corresponding group. The individual responsible for generating the randomization list will not participate in any other aspect of the study to prevent selection biases and ensure a uniform distribution of characteristics across both groups. This process aids in reducing the imbalance of confounding factors between the study groups and enhances the validity of the results. N/A Upper gastrointestinal disease. Intervention 1: The study protocol will proceed as follows: One day before endoscopy, the researcher will coordinate with the department head to obtain a list of scheduled patients, who will be contacted via phone and instructed to arrive 1.5 hours before the procedure. Interventions will be conducted in the endoscopy waiting rooms. Upon arrival, eligible participants will receive detailed explanations of the study’s objectives and procedures, and written informed consent will be obtained. A demographic questionnaire will then be completed by participants. One hour before endoscopy, physiological parameters—including blood pressure (measured from the left arm using a standardized aneroid sphygmomanometer [ALPK2, Japan]), pulse rate, respiratory rate (counted over one full minute using a Samsung A53 smartphone chronometer), and arterial oxygen saturation (assessed via a pulse oximeter [Zenith Med C101A3, China] on the left index finger)—will be recorded in a seated position with the arm aligned at heart level. Anxiety and fear will be quantified using the Spielberger State-Trait Anxiety Inventory (STAI) and a Visual Analog Scale (VAS), respectively. Pre-intervention preferences for VR content (e.g., religious sites, natural landscapes) will be surveyed. Participants allocated to the virtual reality (VR) group will undergo a 12-minute immersive session using a Shinecon SC-GI5 VR headset (China) with high-quality audiovisual environments (self-selected serene scenes) to divert attention from the procedure and induce relaxation through sensory immersion. Twenty minutes post-intervention, physiological variables, anxiety, and fear will be reassessed. For the rhythmic breathing group, participants will perform controlled breathing exercises (3-second nasal inhalation, 3-second breath-holding, 3-second oral exhalation) in a supine position with closed eyes, repeated at 5-minute intervals over 20 minutes, followed by identical post-intervention measurements. All assessments will be standardized to compare the efficacy of VR versus rhythmic breathing in reducing pre-endoscopy anxiety and fear. Intervention 2: Participants in the rhythmic breathing group will be instructed to close their eyes, assume a supine position, and perform a controlled breathing technique: inhaling through the nose for 3 seconds (counted audibly as “1–3”), holding the breath for 3 seconds, and exhaling through the mouth for 3 seconds. Patients will be directed to focus solely on the inflow and outflow of air during the exercise. The rhythmic breathing protocol will consist of 1-minute sessions repeated every 5 minutes over a 20-minute period, with adherence to the taught method. Physiological parameters (blood pressure, pulse, respiratory rate, arterial oxygen saturation), anxiety (assessed via the Spielberger State-Trait Anxiety Inventory [STAI]), and fear (measured using a Visual Analog Scale [VAS]) will be evaluated at two timepoints: (1) one hour prior to endoscopy (baseline) and (2) 20 minutes post-intervention (20 minutes before the procedure), mirroring the assessment protocol of the virtual reality group to ensure comparability. Yes - There is a plan to make this available What will be shared: We can share all data on primary and secondary outcomes after de-identifying individuals. When: Access period starts 3 months after results are published. To whom: It will be available to researchers working in academic and scientific institutions. Conditions: Scientific and clinical use of data is permitted if permission is obtained and intellectual and material rights are preserved. Where to obtain: Email address, phone numbers, postal address for correspondence mahshad.hasansorodii@gmail.com - 0098 9118045925 zalipoor@gmail.com alipourhabib58@gmail.com How to obtain: The applicant should contact us through the communication channels introduced. After reviewing their request, if there is no conflict with the principles and objectives of the research, the data will be made available to them as soon as possible within a period of 7 days. Comments:
public Mahshad Hasansorodi
Shahid Motahari Street - Enghelab Square - Imam Sajjad Hospital - Fatemeh Zahra (S) Nursing and Midwifery School- Ramsar- Mazandaran- Iran
Ramsar Iran (Islamic Republic of) ۴۶۹۱۷۱۴۱۴۱ +98 11 5521 0828 mahshad.hasansorodii@gmail.com Babol University of Medical Sciences scientific Jannat Alipour Zahra
Shahid Motahari Street - Enghelab Square - Imam Sajjad Hospital - Fatemeh Zahra (S) Nursing and Midwifery School- Ramsar- Mazandaran- Iran
Ramsar Iran (Islamic Republic of) ۴۶۹۱۷۱۴۱۴۱ +98 11 5522 5151 zalipoor@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 and over Consent to participate in the research Awareness and orientation to time and place The first experience of endoscopic examination of the digestive system. ability to communicate verbally 18 years no limit Both Study participation reluctance Visual and auditory impairment History of anxiety and psychological problems Use of medications that affect anxiety K92.2 Gastrointestinal hemorrhage, unspecified Prevention Prevention The study protocol will proceed as follows: One day before endoscopy, the researcher will coordinate with the department head to obtain a list of scheduled patients, who will be contacted via phone and instructed to arrive 1.5 hours before the procedure. Interventions will be conducted in the endoscopy waiting rooms. Upon arrival, eligible participants will receive detailed explanations of the study’s objectives and procedures, and written informed consent will be obtained. A demographic questionnaire will then be completed by participants. One hour before endoscopy, physiological parameters—including blood pressure (measured from the left arm using a standardized aneroid sphygmomanometer [ALPK2, Japan]), pulse rate, respiratory rate (counted over one full minute using a Samsung A53 smartphone chronometer), and arterial oxygen saturation (assessed via a pulse oximeter [Zenith Med C101A3, China] on the left index finger)—will be recorded in a seated position with the arm aligned at heart level. Anxiety and fear will be quantified using the Spielberger State-Trait Anxiety Inventory (STAI) and a Visual Analog Scale (VAS), respectively. Pre-intervention preferences for VR content (e.g., religious sites, natural landscapes) will be surveyed. Participants allocated to the virtual reality (VR) group will undergo a 12-minute immersive session using a Shinecon SC-GI5 VR headset (China) with high-quality audiovisual environments (self-selected serene scenes) to divert attention from the procedure and induce relaxation through sensory immersion. Twenty minutes post-intervention, physiological variables, anxiety, and fear will be reassessed. For the rhythmic breathing group, participants will perform controlled breathing exercises (3-second nasal inhalation, 3-second breath-holding, 3-second oral exhalation) in a supine position with closed eyes, repeated at 5-minute intervals over 20 minutes, followed by identical post-intervention measurements. All assessments will be standardized to compare the efficacy of VR versus rhythmic breathing in reducing pre-endoscopy anxiety and fear. Participants in the rhythmic breathing group will be instructed to close their eyes, assume a supine position, and perform a controlled breathing technique: inhaling through the nose for 3 seconds (counted audibly as “1–3”), holding the breath for 3 seconds, and exhaling through the mouth for 3 seconds. Patients will be directed to focus solely on the inflow and outflow of air during the exercise. The rhythmic breathing protocol will consist of 1-minute sessions repeated every 5 minutes over a 20-minute period, with adherence to the taught method. Physiological parameters (blood pressure, pulse, respiratory rate, arterial oxygen saturation), anxiety (assessed via the Spielberger State-Trait Anxiety Inventory [STAI]), and fear (measured using a Visual Analog Scale [VAS]) will be evaluated at two timepoints: (1) one hour prior to endoscopy (baseline) and (2) 20 minutes post-intervention (20 minutes before the procedure), mirroring the assessment protocol of the virtual reality group to ensure comparability. Situational anxiety. Timepoint: Before and after the intervention. Method of measurement: Spielberger’s Anxiety Inventory. Fear. Timepoint: Before and after the intervention. Method of measurement: Visual Analogue Scale. Blood pressure. Timepoint: Before and after the intervention. Method of measurement: Pressure gauge device. Heart rate. Timepoint: Before and after the intervention. Method of measurement: Pulse oximeter. Respiratory rate. Timepoint: Before and after the intervention. Method of measurement: Mobile phone stopwatch. Arterial blood oxygen saturation percentage. Timepoint: Before and after the intervention. Method of measurement: Pulse oximeter. Babol University of Medical Sciences Approved 2025-01-22 Health Research Institute, Babol University of Medical Sciences Shahid Motahari Street - Enghelab Square - Imam Sajjad Hospital - Fatemeh Zahra (S) Nursing and Midwifery School- Ramsar- Mazandaran- Iran Ramsar Mazandaran Iran (Islamic Republic of)