Sleep Quality, Stress Level and Heart Rate Variability of University Students

Sleep Quality Clinical Trial

Official title:

The Effect of Mindfulness-Based Stress Reduction Intervention on Sleep Quality, Stress Level and Heart Rate Variability of University Students

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05296616
• Other study ID #: 2022/03-835
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: January 18, 2023

Study information

• Verified date: March 2022
• Source: Istanbul Yeni Yüzyil Üniversitesi
• Contact: Merve Bat Tonkus, PhD Cand
• Phone: 05055951889
• Email: mervebat.tonkus[@]yeniyuzyil.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on sleep quality, stress level and heart rate variability of university students Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test.

Hypotheses:

H1: The sleep quality level scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to the students in the control group. H2: Students in the intervention group participating in the mindfulness-based stress reduction initiative will decrease their stress level level scores compared to the students in the control group. H3: The heart rate variability of the students in the intervention group participating in the mindfulness-based stress reduction initiative will be higher than the students in the control group.

H4: The sleep quality level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to their pretest scores. H5: The stress level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores. H6: The heart rate variability level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 18, 2023
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 45 Years

Eligibility

Inclusion Criteria:

• Being a student of the relevant faculty,

• No barriers to accessing technology for participation in the online program,

• No visual or hearing impairment

Exclusion Criteria:

• Not being a student of the relevant faculty,

• Having barriers to accessing technology for participation in the online program,

• Having visual or hearing impairment

Related Conditions & MeSH terms

• Heart Rate Variability
• Sleep Quality

Intervention

Behavioral:
• Mindfulness Based Stress Reduction Intervention
Mindfulness Based Stress Reduction intervention is a manualized course that includes meditation, relaxing movement, and breathing. A certified MBSR instructor will teach the courses in a group-based format for 90 minute sessions, once per week for eight weeks.

Locations

Country	Name	City	State
Turkey	Merve Bat Tonkus	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Yeni Yüzyil Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality Level	The Pittsburgh Sleep Quality Index: The 18 items scored are divided into 7 component scores. Some ingredients consist of a single substance, while others are obtained by combining several substances. Each item is assessed on a scale between 0-3. These components are; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction. The sum of these seven component scores gives the overall index score. Your total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence or prevalence of sleep disorders.	for 8 months
Secondary	Stress Level	Perceived Stress Scale is a scale consisting of 14 questions. Participants in the study evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)." The Perceived Stress Scale includes 7 (items 4.5.6.7.9.10. and 13.) reverse scored statements. Total scale scores range from 0 to 56. An increase in the total score indicates an increase in the perceived stress level of the individual.	for 8 months
Secondary	Heart Rate Variability	CorSense HRV monitors were purchased from the Elite HRV company for use in the study. Readings will be collected through the Elite HRV app designed for mobile devices.; RMSSD and LF/HF data will be received for each reading from the application. According to the Elite HRV website, the platform includes RMSSD calculations for the R-R range recorded by industry standards and defines 0.04-0.15 Hz waves as LF and 0.15-0.40 Hz waves as HF.	for 8 months