Clinical trial NCT06501027: Mindfulness-Based Self-Compassion and Vagal Nerve Stimulation on Heart Rate Variability, Psychological Resilience, and Sleep Quality
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Rate Variability
Psychological Resilience
Sleep Quality
Keywords: Mindfulness-Based Self-Compassion Intervention
Vagal Nerve Stimulation
earthquake victims
Lead sponsor: İstanbul Yeni Yüzyıl Üniversitesi
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Heart Rate Variability
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Psychological Resilience
timeFrame: up to 4 weeks
measure: pittsburgh sleep quality index
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: İstanbul Yeni Yüzyıl Üniversitesi
name: Merve Bat Tonkuş, Dr.
role: STUDY_CHAIR
References: