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Clinical Trials/NCT06501027
NCT06501027
Not yet recruiting
Not Applicable

The Effect of Mindfulness-Based Self-Compassion Intervention and Vagal Nerve Stimulation on Heart Rate Variability, Psychological Resilience, and Sleep Quality in Earthquake Survivors

İstanbul Yeni Yüzyıl Üniversitesi0 sites26 target enrollmentJuly 12, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Rate Variability
Sponsor
İstanbul Yeni Yüzyıl Üniversitesi
Enrollment
26
Primary Endpoint
Heart Rate Variability
Status
Not yet recruiting
Last Updated
last year

Overview

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."

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.

Registry
clinicaltrials.gov
Start Date
July 12, 2024
End Date
October 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
İstanbul Yeni Yüzyıl Üniversitesi
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults aged between 18 and 35,
  • who have been exposed to an earthquake and have relocated to Istanbul,
  • who are accessing psychological first aid information channels.

Exclusion Criteria

  • Individuals with a psychiatric diagnosis

Outcomes

Primary Outcomes

Heart Rate Variability

Time Frame: up to 4 weeks

Heart Rate Variability (HRV) refers to the variation in the time interval between heartbeats. It is a measure of the slight differences in timing between successive heartbeats, often measured in milliseconds. HRV is regulated by the autonomic nervous system, which controls involuntary bodily functions, including heart rate.

Secondary Outcomes

  • Psychological Resilience(up to 4 weeks)
  • pittsburgh sleep quality index(up to 4 weeks)

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