The following section describes the recruitment process and ethics for the study to determine if a mindfulness-based stress relief program reduces anxiety in patients undergoing cardiac rehabilitation. A sample of adults who have had coronary artery bypass surgery (CABG), and are now enrolled in a heart rehabilitation program, will be recruited for the study. Below are details about the recruitment strategy and inclusion/exclusion criteria. The sample size and selection process will be discussed. The study setting and ethical considerations (including informed consent and protection for human subjects) are also described.
Recruitment Strategy: The study participants will be selected from the cardiac rehabilitation program of a major teaching hospital in northeast. In order to find eligible participants, the principal investigator and program coordinator will team up. Coordinators will review potential participants and give them a short description about the study. To provide additional information, and to answer any queries, the principal investigator will continue following up with participants who have expressed interest.
Adult patients aged 18 years or older will be included in the study. They must have had CABG surgery within six months. Fluent English proficiency is required. Participants should be able to give informed consent and are willing to participate in eight mindfulness-based stress management sessions each week.
Criteria for Exclusion: Participants who have a history or cognitive impairment that could prevent them participating in this study, as well as patients with any psychiatric disorders, will not be allowed to participate. Patients who participated previously in a mindfulness-based program for stress reduction will also be excluded.
Sample Type. The study will use a purposive sample that includes patients who agree to be included in it.
For this study, a sample of 30 people is recommended. These numbers are based upon previous studies which used similar sizes and showed significantly lower anxiety in patients undergoing cardiac rehabilitation (Jain, Loucks, et. al. 2015). 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: Based on the above inclusion and exclusion criteria, participants will be chosen using non-random sampling methods.
Study will be conducted in the proposed location of the cardiac rehabilitation program at an academic hospital. In the rehab facility, there will be a conference room for this study. To ensure mindfulness practice, the actual setting will be decided in consultation with the program coordinator.
Ethical considerations and informed consent
Before the study can begin, approval must be received from the Institutional Review Board. First, the principal investigator must submit a proposal and application to Regis College IRB. The IRB must approve any institution that will host the study after it has been approved by Regis College. As the study presents minimal risk to participants, expedited review is possible. All participants will have to give informed consent. They will also be informed about their rights to withdraw at any point without being penalized.
Participants’ identifying data will remain confidential and private, as well as informed consent documents. They will keep their data in a separate file from any de-identified data such demographics, surveys and transcripts to protect privacy. 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.
Here you will find information about the plan for recruitment, exclusion criteria and sample size.