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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Quality; Heart Rate Variability; Stress Level
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merve Bat Tonkus, PhD Cand; Phone Number: 05055951889; Email: mervebat.tonkus@yeniyuzyil.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Merve Bat Tonkus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 41 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MSQSLHRV; The group in which the mindfulness-based stress reduction intervention will be implemented.	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.
No Intervention: Control; The group to which mindfulness-based stress reduction intervention will not be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: İstanbul Yeni Yüzyıl Üniversitesi

Study record dates

Study Major Dates

• Study Start (Anticipated): May 18, 2022
• Primary Completion (Anticipated): November 18, 2022
• Study Completion (Anticipated): January 18, 2023

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2022/03-835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No