Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT06501027
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
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?: