ImpleMENTing meditatiOn into heart disease clinical settings (The MENTOR Study)

Materials: An audio CD and a CD player will be used by the facilitator to guide participants through a meditation intervention. Participants will be given a copy of the audio CD, tape, USB stick or will be given access to a free online platform of the meditation intervention sent via an e-mail link for home practice. A topic guide will be used for the post-intervention focus groups that will occur in week 7 (Refer Appendix: Focus group and interview guide). Procedure: This meditation intervention will consist of 6 consecutive weekly group sessions of 16 minutes duration in addition to conventional cardiac rehabilitation. Participants will be contacted the Friday before the meditation intervention (Refer Appendix: Participant Timeline). On arrival to cardiac rehabilitation on the first day of the intervention, participants will have their baseline measures evaluated. They will then complete their cardiac rehabilitation exercise sessions for that day. Following cardiac rehabilitation, participants will have their blood pressure and salivary cortisol levels reassessed (Refer Appendix: Study Design). Intervention participants will then be taken to a private room where the meditation intervention will be delivered. An audio CD will be used by the facilitator to guide participants through deep breathing, a ‘body scan’ that sequentially draws focused attention to body parts, followed by instrumental music designed to calm the mind and facilitate a meditative state. Participants will then sit in the shared space with the facilitator for 2 to 3 minutes before being gradually guided back to normal awareness. Participants will be given a copy of the audio CD, tape, USB stick or access to a free online platform of the meditation intervention and advised to adhere to daily home meditation practice for 16 minutes at the same time and in the same place if possible. They will be asked to do this home meditation on each day that they are not attending the group meditation session (6 days per week for 6 weeks). Meditation practice should occur in a quiet space that is uninterrupted. This can be in the bedroom, outside in the garden or any other area, and can be made comfortable with a chair, pillows or a bed. Participants will be asked to complete a log sheet of the number of home meditation sessions completed, including date, duration, and location of their meditation practice. The log sheets will be collected by the research team weekly. The number of online home practice sessions and the duration of these sessions will be tracked by the research team. In week 7, participants will be invited to participate in focus groups consisting of 6 to 8 adults. A copy of the interview guide for these focus groups is outlined in the Appendix (Participant focus group and interview guide). An opportunity for a short personal interview will be given after the focus group to allow participants to share information they may not have been comfortable sharing within the group about their experiences with meditation or environmental or lifestyle factors affecting their participation. No incentives will be offered for participation. Strategies to improve adherence At the group meetings, before each meditation session, the facilitator will lead a short 1-2 minute per person check in’ to identify any issues or challenges participants are having with the practice. Prior to the first meditation, a short explanation of the steps involved in the meditation will be explained to participants, and participants will have an opportunity to share what they are hoping to gain by using meditation. Participants will be reassured that initially, chatter that occurs within the mind can be difficult to quieten and that this is part of the process, but as practice continues, it becomes easier over time to quiet the mind. A record of de-identified screening statistics and key dates (for example, study ID, date of recruitment, allocation, site, date of intervention, and attendance in the number of weeks will be kept by the research team). Participants allocated to the intervention group will be contacted the day before, or the Friday prior (for Monday sessions) to the commencement of the group meditation intervention and reminded of the date, time, and venue (refer to Participant Timeline in Appendices). A free online platform will be created to allow participants to log in to the meditation website and complete their assigned home practice if they prefer this mode of delivery (as opposed to a CD player). This online platform will automatically tabulate the number of sessions completed according to the times logged in to complete meditation practice. Follow up telephone calls will be made to participants or an online survey link generated via REDCap will be sent to participants' e-mail address at 3 months regarding mental health and well-being, and whether participants had chosen to continue to use meditation outside of the intervention period. Whilst participants may decide to keep a personal diary of experiences during meditation, this data will not be collected. Both the meditation intervention group and usual care control group will be able to participate in cardiac rehabilitation. There will be no alteration to their cardiologist or other outpatient follow up appointments or medications unless advised by the relevant health professional, nor restrictions to use of other complementary and alternative therapies. Who will deliver the intervention: This meditation intervention will be delivered by a registered nurse and researcher with extensive (over 13 years) acute clinical nursing experience. She has conducted a previous Australian Research Council Category 1 funded study in the same cardiac rehabilitation setting and has completed online Good Clinical Practice Training for Investigational Sites and Sponsors provided by ARCS Australia. The researcher also has over 13 years’ meditation practitioner experience, including completion of the 8 week Mindfulness Based Stress Reduction course, completion of a 2.5 day silent meditation retreat, fortnightly attendance at a closed group meditation for over 13 years, and has an established personal meditation practice. Focus groups will be facilitated by a member of the research team with extensive clinical research and qualitative research experience. Mode of intervention delivery: This meditation intervention will consist of 6 weekly face to face group sessions of 16 minutes duration in addition to conventional cardiac rehabilitation. In addition, participants will be given a copy of the audio CD, tape, USB stick or access to a free online platform sent via e-mail link of the meditation intervention and advised to adhere to daily home meditation practice for 16 minutes at the same time and in the same place if possible. Participants will be asked to do this home meditation on each day that they will not attend the group meditation sessions. At week 7, participants will be invited to participate in focus groups consisting of 6 to 8 adults. An opportunity for a short personal interview will be given after the focus group to allow participants to share information they may not have been comfortable sharing within the group about their experiences with meditation or environmental or lifestyle factors affecting their participation. Follow up telephone calls will be made to participants or an online survey link will be sent to participants' e-mail address at 3 months regarding mental health and well-being, and whether participants had chosen to continue to use meditation outside of the intervention period. The number of times the intervention was delivered: This meditation intervention will be delivered on the Monday morning after participants have completed their cardiac rehabilitation exercise program for that day. Prior to the meditation intervention, the researcher will facilitate a 1-2 minute per person check in with the group to ascertain how each participant is going and any difficulties they are having with their meditation practice. The group meditation intervention will be of 16 minutes duration. Participants will then sit in the shared space with the facilitator for 2 to 3 minutes before being gradually guided back to normal awareness. The meditation intervention will be delivered weekly for six consecutive weeks. Participants will be asked to do home meditation practice on each day that they will not attend the group meditation sessions (6 days per week for 6 weeks). Participants will return in week 7 to participate in a focus group of 30 minutes to 1-hour duration. Location: This study took place at a large tertiary referral hospital in Western Sydney, which is a residential area that is culturally diverse and socioeconomically disadvantaged. The meditation sessions will be held in a private meeting room adjacent to the outpatient cardiac gym or in a second private room separate to the inpatient cardiology wards. Doors and windows will be closed to minimise outside noise. Lighting will be dimmed or switched off, and blinds will be closed to inhibit distracting light. Participants will be seated in comfortable chairs that will be set up in a circle. Meditation home practice was advised to occur in a quiet space that was uninterrupted. This could be in the bedroom, outside in the garden or any other area, and participants could be made comfortable with a chair, pillows or a bed. Tailoring: This was a set protocol. There was no set titration.