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

Sponsor
İstanbul Yeni Yüzyıl Üniversitesi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05296616
Collaborator
(none)
60
1
2
8
7.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Based Stress Reduction Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Mindfulness-Based Stress Reduction Intervention on Sleep Quality, Stress Level and Heart Rate Variability of University Students
Anticipated Study Start Date :
May 18, 2022
Anticipated Primary Completion Date :
Nov 18, 2022
Anticipated Study Completion Date :
Jan 18, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Sleep Quality Level [for 8 months]

    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.

Secondary Outcome Measures

  1. Stress Level [for 8 months]

    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.

  2. Heart Rate Variability [for 8 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Merve Bat Tonkus Istanbul Turkey

Sponsors and Collaborators

  • İstanbul Yeni Yüzyıl Üniversitesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merve BAT TONKUŞ, Lecturer, İstanbul Yeni Yüzyıl Üniversitesi
ClinicalTrials.gov Identifier:
NCT05296616
Other Study ID Numbers:
  • 2022/03-835
First Posted:
Mar 25, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 8, 2022