This study will be designed as a randomized clinical trial with four parallel groups. After identifying eligible patients and obtaining written informed consent, participants will be assigned to one of four study groups.
Randomization Method (Time-Block Randomization)
This study will use a time-block randomization method. In this way, the study period will be divided into predetermined time blocks (for example, weekly or monthly), and in each time block, only one of the four study groups will be considered as the assigned group.
At the end of each time block, the group assignment will change, and this process will continue until the desired sample size is completed in all four groups. The order of group assignment to time blocks will be determined randomly.
This method will be used to facilitate the implementation of the intervention, prevent interference between interventions, and reduce information contamination between groups, and is classified as a quasi-randomized method.
Randomization unit
The randomization unit in this study will be the individual; however, the allocation of individuals will be based on time blocks, meaning that all patients admitted in any given time period will be placed in the same group assigned to that time block.
Randomization strata
In this study, stratified randomization will not be performed, and background variables such as age, gender, or baseline anxiety severity will not be considered in the group allocation process.
Randomization tool
The order of allocation of the four study groups to time blocks will be determined using a random number table or statistical software (such as SPSS). This process will be performed by a researcher independent of the intervention implementation team.
How to construct a random sequence
First, the time blocks of the study will be defined. Then, using random numbers, the sequence of allocation of the four study groups to these time blocks will be randomly generated. Patients will be assigned to the assigned group in the order they enter the study and based on the relevant time block.
Allocation Concealment
Given the nature of time randomization, complete concealment of allocation at the individual level will not be possible; however, the sequence of allocation of groups to time blocks will be prepared in advance and maintained by the researcher responsible for randomization, and the interventionists will not be aware of the group allocation for that interval until the beginning of each time block. This will be done to reduce selection bias.
This study will be designed as a single-blind study with blinding of the outcome assessor and data analyst.
Participants (patients):
Participants will be aware of their inclusion in the study and their allocation to one of the four study groups, and written informed consent will be obtained from all of them. The knowledge of participation in the study will not be hidden from the patients, as this is not ethically permissible. Given the nature of the intervention (feedback-based training and/or virtual reality), it will not be possible to blind the patients to the type of intervention they receive. However, patients will not be informed of the research hypotheses, comparisons between groups, and expected outcomes, and they will be asked to refrain from disclosing details of the intervention when completing the research instruments.
Principal Investigator:
The principal investigator will be aware of the group allocation of patients due to his/her direct role in the design, organization, and implementation of the interventions; however, he/she will not participate in the process of collecting outcome data and statistical analysis to avoid bias.
Healthcare personnel:
Therapeutic personnel (physicians and nurses in the angiography department) who will be responsible for routine patient care will not be involved in the randomization process and allocation of patients to the four study groups and will not be aware of the type of educational intervention received by the patients. Routine care will be provided to all patients in all four groups according to the department's standard protocol.
Data collectors and outcome assessors:
Data collection related to study outcomes, including patient anxiety, will be performed by an individual or individuals who will not be aware of the group allocation of participants to the four study groups. Outcome assessment will be performed based on standard instruments and using anonymous codes for the groups to maintain blinding of the assessors.
Data analysts:
Statistical analysis of the data will be performed by a researcher who will not be aware of the type of intervention and allocation of patients to the four study groups and the data will be provided to him/her in coded form.
Data Safety and Monitoring Committee (DSMC):
Due to the non-invasive and low-risk nature of educational and virtual reality interventions, an independent data safety and monitoring committee will not be formed; however, any potential complications will be recorded and monitored continuously during the study.
Drafters of the article:
A draft of the article will be prepared based on the coded data after data collection and statistical analysis are completed to avoid bias in the interpretation of the results.