This section outlines the planned recruitment and ethical considerations for the proposed study on the effectiveness of a mindfulness-based stress reduction program in reducing anxiety levels in cardiac rehabilitation patients. The study aims to recruit a sample of adult patients who have undergone coronary artery bypass graft (CABG) surgery and are enrolled in a cardiac rehabilitation program. The proposed recruitment strategy, inclusion and exclusion criteria, sample size, and selection method are discussed below. In addition, the setting for the study and the ethical considerations, including informed consent and protection of human subjects, are described.
Recruitment Strategy: Participants for this study will be recruited from a cardiac rehabilitation program at a large teaching hospital in the northeast. The principal investigator will collaborate with the program coordinator to identify eligible participants. The coordinator will screen potential participants for inclusion criteria and provide them with a brief description of the study. The principal investigator will follow up with those who express interest to provide more detailed information and answer any questions.
Inclusion Criteria: The study will include adult patients (18 years and older) who have undergone CABG surgery within the past six months and are currently enrolled in a cardiac rehabilitation program. Participants must be fluent in English, able to provide informed consent, and willing to attend eight weekly mindfulness-based stress reduction sessions.
Exclusion Criteria: Patients with a history of a psychiatric disorder, cognitive impairment, or a medical condition that would prevent them from participating in the study will be excluded. Patients who have previously participated in a mindfulness-based stress reduction program will also be excluded.
Sample Type: The sample will be purposive, consisting of patients who meet the inclusion criteria and agree to participate in the study.
Sample Size: A sample size of 30 participants is proposed for this study. The rationale for this choice is based on previous studies that have used a similar sample size and demonstrated significant reductions in anxiety levels following mindfulness-based stress reduction programs in cardiac rehabilitation patients (Jain et al., 2015; Loucks et al., 2016). In addition, a sample size of 30 will provide adequate statistical power to detect a medium effect size (Cohen’s d = 0.5) with a two-tailed alpha level of 0.05 and power of 0.80.
Selection Method: Participants will be selected using a non-random sampling method, based on the inclusion and exclusion criteria outlined above.
The proposed setting for this study is the cardiac rehabilitation program at a large teaching hospital in the northeast. The study will take place in a private conference room within the rehabilitation facility. The actual location will be determined in collaboration with the program coordinator to ensure that the setting is comfortable and conducive to mindfulness practice.
Informed Consent and Ethical Considerations
Institutional Review Board (IRB) approval will be obtained before the study begins. The principal investigator will submit an application and proposal to the Regis College IRB first. After approval from Regis College, the institution where the study will take place usually requires IRB approval as well. The study is expected to qualify for expedited review, as it poses minimal risk to participants. Informed consent will be obtained from all participants, and they will be informed of their right to withdraw from the study at any time without penalty.
To protect the privacy and confidentiality of participants, identifying data, including informed consent documents, will be maintained in a locked file separate from de-identified data, such as demographics, surveys, and transcripts. The data will be stored in a locked file in the researcher’s locked office for the duration of the study and for a period of seven years after completion, as required by the hospital’s policy on retention of research records.
This section has outlined the planned recruitment strategy, inclusion and exclusion criteria, sample size