Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501027
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-04
Brief Title:
Mindfulness-Based Self-Compassion and Vagal Nerve Stimulation on Heart Rate Variability Psychological Resilience and Sleep Quality
Sponsor:
İstanbul Yeni Yüzyıl Üniversitesi
Organization:
İstanbul Yeni Yüzyıl Üniversitesi
Study Overview
Official Title:
The Effect of Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation on Heart Rate Variability Psychological Resilience and Sleep Quality in Earthquake Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was conducted to determine the effects of a mindfulness-based self-compassion intervention and vagal nerve stimulation on heart rate variability psychological resilience and sleep quality in earthquake victims
Design The study was designed as a randomized experimental research where pre- and post-intervention measurements were administered to Intervention I and Intervention II groups
Design The study was designed as a randomized experimental research where pre- and post-intervention measurements were administered to Intervention I and Intervention II groups
Detailed Description:
Hypotheses
H1 The post-intervention sleep quality scores of earthquake victims in the intervention group who received Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation will be higher than their scores before the intervention
H2 The Psychological Resilience Scale scores of earthquake victims in the intervention group who received Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation will be higher post-intervention compared to pre-intervention
H3 The post-intervention heart rate variability of earthquake victims in the Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation intervention group will be higher than their pre-intervention levels
H4 The earthquake victims in the Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation intervention group will exhibit higher post-intervention sleep quality scores compared to those in the Vagal Nerve Stimulation-only group
H5 Earthquake victims in the intervention group receiving Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation will demonstrate higher Psychological Resilience Scale scores post-intervention compared to those in the group receiving only Vagal Nerve Stimulation
H6 Earthquake victims in the intervention group receiving Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation will show higher post-intervention heart rate variability compared to those in the group receiving only Vagal Nerve Stimulation
H1 The post-intervention sleep quality scores of earthquake victims in the intervention group who received Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation will be higher than their scores before the intervention
H2 The Psychological Resilience Scale scores of earthquake victims in the intervention group who received Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation will be higher post-intervention compared to pre-intervention
H3 The post-intervention heart rate variability of earthquake victims in the Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation intervention group will be higher than their pre-intervention levels
H4 The earthquake victims in the Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation intervention group will exhibit higher post-intervention sleep quality scores compared to those in the Vagal Nerve Stimulation-only group
H5 Earthquake victims in the intervention group receiving Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation will demonstrate higher Psychological Resilience Scale scores post-intervention compared to those in the group receiving only Vagal Nerve Stimulation
H6 Earthquake victims in the intervention group receiving Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation will show higher post-intervention heart rate variability compared to those in the group receiving only Vagal Nerve Stimulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None