Mindfulness-Based Self-Compassion and Vagal Nerve Stimulation on Heart Rate Variability, Psychological Resilience, and Sleep Quality

NCT06501027 | Not Yet Recruiting

• 1 other identifier: 2023/07-1075
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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."

Conditions

Heart Rate Variability; Psychological Resilience; Sleep Quality

Keywords

Mindfulness-Based Self-Compassion Intervention; Vagal Nerve Stimulation; earthquake victims

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  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.

  up to 4 weeks

Secondary Outcomes (2)

• Psychological Resilience

  up to 4 weeks

• pittsburgh sleep quality index

  up to 4 weeks

Study Arms (2)

Mindfulness-Based Self-Compassion and vagal nerve stimulation

EXPERIMENTAL

Mindfulness-Based Self-Compassion and vagal nerve stimulation were administered to the Intervention I group. Mindfulness-Based Self-Compassion intervention is a manualized course that includes meditation, relaxing movement, and breathing. A certified Mindfulness-Based Self-Compassion instructor will teach the courses in a group-based format for 90 minute sessions, once per week for three weeks. Vagal nerve stimulation was administered to all participants in both groups using the on-invasive Auricular Vagus Nerve Stimulation device. The stimulation was biphasic, with a frequency of 10 Hz and a pulse width of 300 μs in Modulation mode. Current intensity was adjusted by attaching the device to the participant's right or left ears, ensuring that they felt the current comfortably, and maintaining a constant level. Stimulation sessions occurred every 3 weeks, with non-invasive auricular vagus nerve stimulation applied for 20 minutes per session over a period of 3 days.

Behavioral: Mindfulness Based Self Compassion

Vagal nerve stimulation

EXPERIMENTAL

Only vagal nerve stimulation was administered to the Intervention II group. Vagal nerve stimulation was administered to all participants in both groups using the Non-invasive Auricular Vagus Nerve Stimulation device. The stimulation was biphasic, with a frequency of 10 Hz and a pulse width of 300 μs in Modulation mode. Current intensity was adjusted by attaching the device to the participant's right or left ears, ensuring that they felt the current comfortably, and maintaining a constant level. Stimulation sessions occurred every 3 weeks, with non-invasive auricular vagus nerve stimulation applied for 20 minutes per session over a period of 3 days.

Behavioral: Mindfulness Based Self Compassion

Interventions

Mindfulness Based Self Compassion BEHAVIORAL

The intervention has its roots in meditations and yoga practices. However, it is independent of religious purpose or affiliation.The weekly sessions include a range of mental and bodily practices, including awareness of

Mindfulness-Based Self-Compassion and vagal nerve stimulation; Vagal nerve stimulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Individuals with a psychiatric diagnosis

Sponsors & Collaborators

• İstanbul Yeni Yüzyıl Üniversitesi: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Merve Bat Tonkuş, Dr.

  İstanbul Yeni Yüzyıl Üniversitesi

  STUDY CHAIR

Central Study Contacts

Merve Bat Tonkuş, Dr.

CONTACT

+905055951889; batmerve@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: July 15, 2024
• Study Start: July 12, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share