This study employs a randomized crossover clinical trial design with three interventional arms and a baseline assessment phase, in which the unit of randomization is the individual participant. Following verification of eligibility criteria and obtaining signed informed consent, each participant is randomly assigned to one of six possible sequences for receiving the three interventions (namely ABC, ACB, BAC, BCA, CAB, and CBA). To ensure balanced distribution of participants across these six sequences, a balanced block randomization method is utilized.
The generation of random sequences is the responsibility of an independent researcher who has no involvement in participant recruitment, intervention administration, or outcome assessment. This process is carried out using IBM SPSS Statistics version 27 software, based on computer-generated random numbers. The final allocation list remains confidential within the research team, and to conceal the allocation process, the sequence assigned to each participant is placed in opaque, light-proof, sealed, and sequentially numbered envelopes.
Once the baseline assessments are completed for each individual and they are formally enrolled in the study, the envelope containing their registration number is opened by the principal investigator, revealing the order in which the interventions are to be administered for that participant. It is worth noting that prior to the opening of the envelopes, all researchers involved in recruitment, baseline evaluations, and data analysis remain blinded to the sequence assigned to each participant.