Effect of Virtual Reality on Anxiety, Stress, Pain and Patient`s Satisfaction among Palestinian Patients Undergoing Colonoscopy: A Randomized Controlled Trial

1. The researcher starts collecting data from patients before starting procedure, patients will complete socio-demographic data, STAI, and PSS-10, which take approximately 25–30 minutes.
2. The patient will receive an immersive VR intervention that includes meditative 3D videos for the natural environment by head-mounted device, and earphones to listen to soothing nature sounds for 30 minutes.
3. Post procedure, the researcher redistributed questionnaires among patients in both groups, which included STAI and PSS-10, and VAS to evaluate patients' satisfaction levels and pain level which take approximately 25–30 minutes.

3. What is the procedure that is being tested? (If applicable)
1. On the prior of colonoscopy procedure, patients will be informed by the researcher about the purpose of the study and the principles of the VR headset; and written consent form will be obtained from them. Patients will complete Socio-demographic data, STAI and PSS-10. They will also be randomly assigned to the experimental group (VR group) and control group.
2. The patients assigned to the VR group will receive a VR intervention that includes meditative 3D videos for the natural environment by a head-mounted device and earphones to listen to soothing nature sounds for 15-30 minutes. For the natural environment that will be presented by VR glasses, universes were proposed: tropical beach, diving, forests, snowy landscape, with relaxing music with nature sound and the patient can choose one of them. It will be selected based on Guided Meditation VR application, developed by CUBICLE NINJAS AGENCY. https://guidedmeditationvr.com/.
3. The patient will wear a VR headset for 5 minutes before colonoscopy procedure and continue wear it during procedure according to patients’ tolerance ( max time 30min), and average total time to wear VR head set before and during colonoscopy procedure approximately 15-30 minutes. During this time, the researcher will make close observations of the patient and help if needed. there is a patient who feels uncomfortable and has motion sickness and wants to stop using VR, the researcher will remove the VR headset immediately, help and support, and evaluate the patient's condition until it is stable.
4. Standard colonoscopy will be performed on the patients in the control group, without any additional intervention.
5. Colonoscopy will be performed on patients in both groups by the same gastroenterologist without the use of anesthesia. After positioning the patients in the left lateral position for the colonoscopy procedure, lidocaine local anesthetic and Vaseline will be applied to the anal area before starting colonoscopy. BUT during procedure, if patients feel discomfort and unable to tolerate procedure without anesthesia can be used conscious sedation with pethidine and /or midazolam according to the standard of care, with the dose increased at physician discretion. All these events will be recorded.
6. During the procedure, hemodynamic parameter monitoring will be performed on all patients in both groups (control group and VR group) every 15 minutes until the procedure is completed.
7. Post-procedure, PSS-10 and STAI will be redistributed among patients in both groups. Also, VAS will be used to evaluate pain level and patients' satisfaction levels. In addition, total time of colonoscopy procedure, dose of sedation if needed, the time the patient needed the anesthesia
8. If any patient has moderate to high level of anxiety, stress and pain post procedure, the researcher will be take action reduce it, some of the management include: learning about anxiety, mindfulness, relaxation techniques, correct breathing techniques according to patient preference.

2024-08-18

2024-12-18

To investigate the effect of virtual reality on anxiety, stress, pain, and patients’ satisfaction among Palestinian patients undergoing colonoscopy.

An experimental design known as randomized control trials (RCT) will be used in this study. Such a design fits the nature of the problem under investigation; an RCT will be used to investigate the effect of a new intervention without bias. This is because the act of randomization balances participant characteristics (both observed and unobserved) between the groups, allowing the attribution of any differences in outcome to the study intervention (Hariton & Locascio, 2018).

Purposive sample will be employed in this study. Patients will be selected by conducting a form of list for programmed operations that are stored in the health-system programs in hospitals affiliated with the Palestinian Ministry of Health. Patients who meet the inclusion criteria will be randomly assigned to two groups: immersive VR group and control-group. Randomized block design will be used to select and divide participants into different groups to avoid selection bias. It ensures that participants are assigned to groups with an equal probability, and the same number of participants for each group. Also, will be prepared opaque, sealed envelopes numbered sequentially to conceal the allocation sequences (Chiu et al., 2023). For blinding, because of the nature of the intervention, the participants and researcher could not be blinded, only the anesthesiologist will be blind to the patients’ groups during the regional anesthesia procedure.

Randomized block design will be used to select and divide participants into different groups to avoid selection bias.

Randomized block design will be used to select and divide participants into different groups to avoid selection bias.

No

The total sample was 150 participants 75 participants per group (75 in VR group and 75 in control group).

The total sample was 150 participants 75 participants per group (75 in VR group and 75 in control group).

The total sample was 150 participants 75 participants per group (75 in VR group and 75 in control group).