Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT06867367
Brief Summary:
This research study aims to explore whether a set of simple breathing techniques and guided meditations can improve the psychological well-being and recovery of ICU survivors and their caregivers.
ICU survivors and their caregivers often experience high levels of stress, anxiety, and depression after discharge. This study investigates whether practicing Isha Kriya, a guided meditation, and Nadi Shuddhi, a breathing technique, can support their mental health and relationship quality. These practices are delivered through a mobile app or in a group setting.
Participants enroll as a caregiver-patient dyad and will engage in these techniques throughout the study. In addition to the practices, brain activity will be recorded using a safe, non-invasive EEG device. The EEG, a lightweight cap with small sensors, measures brainwaves to assess potential changes in brain function and connection. EEG recordings will take place in the hospital during two sessions, each lasting approximately 40 minutes.
Participants will also complete short surveys at five time points throughout the study, assessing mood, stress, and relationship quality. Baseline demographic information will be collected, and at the conclusion of the study, a brief interview will be conducted to gather feedback on the experience.
The study spans approximately seven weeks, with the overall goal of determining whether these breathing and meditation practices can provide accessible and scalable mental health support for ICU survivors and their caregivers.
Detailed Description:
Overview of the Study This study will evaluate the feasibility of implementing a mindfulness-based intervention, Inner Engineering (IE) practices, with concurrent EEG measurements among elderly ICU survivors aged 60 to 85 years and their caregivers. The intervention includes Isha Kriya and Nadi Shuddhi, two simple and accessible meditation practices delivered via a secure digital platform. The study aims to assess feasibility, acceptability, and barriers to implementation while testing paired EEG hyperscanning to explore neural congruency between participants. Conducted in two phases, the study will refine the research infrastructure and optimize the delivery of IE practices, first in the hospital setting and then remotely in home environments.
Overall Study Design This proof-of-concept pilot study utilizes an interventional, mixed-methods design combining experimental feasibility testing, EEG hyperscanning, and qualitative assessments. The study is divided into two phases: Phase 1 focuses on refining infrastructure for delivering IE and EEG monitoring in the hospital, while Phase 2 transitions to evaluating the feasibility of remote intervention delivery and monitoring in participants' homes.
Intervention Isha Kriya, a 15-minute guided meditation, and Nadi Shuddhi, a 3-5-minute alternate-nostril breathing practice. Participants in the intervention groups will be instructed to practice ideally twice or at least once daily. The study interventions will be introduced in-person for patients and either in-person or remotely for their caregivers. After the initial introduction, the interventions will be administered via the 3Cs app. This application has been used for meditation interventions and allows accurate tracking of usage metrics.
Nadi Shuddhi - a gentle 4-minute breathing practice for creating mental balance and relaxation, to be practiced for a minimum of 4 minutes daily.
https://www.youtube.com/watch?v=q5m6tMjcF8k
Isha Kriya - a 15-minute guided meditation that incorporates the breath and the awareness to create mental clarity and health, to be practiced at least once (ideally twice) daily. https://www.youtube.com/watch?v=EwQkfoKxRvo
Phase 1: Refining Hospital-Based Procedures Phase 1 focuses on establishing the research infrastructure within the hospital setting to optimize the implementation of Inner Engineering (IE) practices and EEG hyperscanning. Two ICU survivor-caregiver dyads will be recruited, with survivors defined as individuals aged 60-85 years who experienced an ICU stay of five or more days, and caregivers who self-identify as such and either live with or frequently visit the survivor. Baseline data collection will include high-fidelity EEG hyperscanning and psychological surveys. After learning and practicing IE, participants will complete another EEG hyperscanning data collection and post-intervention assessments. Semi-structured interviews will provide critical feedback on the intervention's acceptability and feasibility, helping to refine study processes for future phases.
Phase 2: Post-Discharge Implementation Phase 2 evaluates the feasibility of implementing IE practices after hospital discharge, focusing on participants' adherence to daily meditation practices. Five ICU survivor-caregiver dyads will be enrolled. At the hospital, baseline data collection will include EEG hyperscanning with the high-density R-Net system and psychological surveys. Participants will then learn the IE practices, with instructions to practice ideally twice or at least once daily. Post-intervention data will be collected afterwards, including EEG hyperscanning and surveys. After discharge to home, participants will be instructed to practice surveys will be completed at weeks 2, 4, and 6. At the end of week 6, a semi-structured interview will gather feedback on the intervention's feasibility, acceptability, and barriers to enrollment or retention.
Study:
NCT06867367
Study Brief:
Protocol Section:
NCT06867367