About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
Elderly ICU survivors aged over 60 years who have experienced long ICU stays of more than five days.
Caregivers who either live in the same household as the survivor or visit more than three times a week.
Age >=85 years (Justification: Assessment instruments not validated in this age group and patients in extremes of age may have limited proficiency to engage in proposed meditative practices)
Trial design
Single group
Treatments tested in this trial
Isha Kriya and Naddi Shuddhi
BehavioralIsha 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.
Treatment groups
Trial outcomes
Primary outcomes
Participant Adherence to the Inner Engineering (IE) Intervention
Adherence will be assessed based on the number of IE sessions each participant completes.
Participant Engagement with the Inner Engineering (IE) Intervention
Engagement will be measured by the frequency of practice logged in the mobile app, indicating participant involvement in the intervention.
Study Retention Rate
Retention will be assessed by tracking the percentage of participants who complete the full study period, including all study assessments.
Secondary outcomes
Changes in Perceived Stress
Changes in perceived stress will be assessed using the Perceived Stress Scale (PSS) to measure perceived stress levels. The PSS ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.
Changes in Psychological distress related to traumatic events
Changes in Psychological distress related to traumatic events will be assessed using the Impact of Event Scale-Revised (IES-R). The IES-R ranges from 0 to 88, with higher scores indicating greater levels of distress related to traumatic events.
Changes in Anxiety and Depressive symptoms
Changes in anxiety and depressive symptoms will be assessed using the Patient Health Questionnaire-4 (PHQ-4). The PHQ-4 ranges from 0 to 12, with higher scores indicating higher levels of depressive symptoms and anxiety.
Changes in Caregivers' Interpersonal Connection
Caregivers' Interpersonal connection will be assessed using the Interpersonal Mindfulness Scale (IMS). The IMS total score involves reverse scoring indicated items and calculating the mean score (between 1 to 5). Higher scores indicate greater mindfulness and interpersonal connection.
Sponsors and contacts
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