Heart Rate VariabilityNCT06501027
Mindfulness-Based Self-Compassion and Vagal Nerve Stimulation on Heart Rate Variability, Psychological Resilience, and Sleep Quality
A study testing Mindfulness Based Self Compassion in people with Heart Rate Variability and Psychological Resilience, run by İstanbul Yeni Yüzyıl Üniversitesi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability, Psychological Resilience, Sleep Quality
- What is being tested?
- Mindfulness Based Self Compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Individuals with a psychiatric diagnosis
Trial locations and contacts
No sites are listed yet.
About this study
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
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."
Read the 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.
- Being tested
- Mindfulness Based Self Compassion
- Keywords
- Mindfulness-Based Self-Compassion Intervention, Vagal Nerve Stimulation, earthquake victims
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Self CompassionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness Based Self Compassion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 weeks
Secondary outcomes (2)
Psychological Resilience
Psychological Resilience Scale for Adults: The scale consists of 33 items; it includes 6 sub-dimensions: The structural style (3,9,15,21) and perception of future (2,8,14,20) subdimensions were measured by 4 items each, the family cohesion (5,11,17,23,26,32), perception of self (1,7,13,19,28,31,), and social competence (4,10,16,22,25,29) subdimensions were measured by 6 items each, and the social resources (6,12,18,24,27,30,33) sub-dimension was measured by 7 items. The score that can be obtained from the scale varies from 33 to 165.
Measured: up to 4 weeks
pittsburgh sleep quality index
It's a self-rated questionnaire that assesses sleep quality and disorders over a one-month period. Seven "component" scores are derived from nineteen separate items. These components include: a) subjective sleep quality, b) sleep latency, c) sleep duration, d) habitual sleep efficiency, e) sleep disorders, f) use of sleeping pills, and g) daytime dysfunction. The sum of these seven component scores yields the index score, with a total score ranging between 0 and 21. A pittsburgh sleep quality index total score of five or higher indicates poor sleep quality.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start12 Jul 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- İstanbul Yeni Yüzyıl Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merve Bat Tonkuş, Dr., Study chair, İstanbul Yeni Yüzyıl Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501027
- Sponsor's protocol ID
- 2023/07-1075
- Status last verified
- Jul 2024
- First submitted
- 4 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06501027
- Acronym / sponsor ID
- 2023/07-1075
- Keywords
- Mindfulness-Based Self-Compassion Intervention, Vagal Nerve Stimulation, earthquake victims
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- İstanbul Yeni Yüzyıl ÜniversitesiUniversity, hospital or other
- Study start
- 12 Jul 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Self-Compassion and vagal nerve stimulation | Experimental | Behavioral: Mindfulness Based Self CompassionMindfulness-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. |
| Vagal nerve stimulation | Experimental | Behavioral: Mindfulness Based Self CompassionOnly 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals with a psychiatric diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Self CompassionThe 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 | Behavioural | Mindfulness-Based Self-Compassion and vagal nerve stimulation, Vagal nerve stimulation |
Primary outcome
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.
2 secondary outcomes
Psychological Resilience
Time frame: up to 4 weeks
pittsburgh sleep quality index
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Bat Tonkuş, Dr. study chair
İstanbul Yeni Yüzyıl Üniversitesi
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Self Compassion in people with Heart Rate Variability and Psychological Resilience, run by İstanbul Yeni Yüzyıl Üniversitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Bat Tonkuş, Dr. (+905055951889, batmerve@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.