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Clinical Trials/NCT05296616
NCT05296616UnknownNot Applicable

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

İstanbul Yeni Yüzyıl Üniversitesi1 site in 1 country60 target enrollmentStarted: May 18, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Sleep Quality Level

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
17 Years to 45 Years (Child, Adult)
Sex
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

Outcomes

Primary Outcomes

Sleep Quality Level

Time Frame: 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 Outcomes

  • Stress Level(for 8 months)
  • Heart Rate Variability(for 8 months)

Investigators

Sponsor
İstanbul Yeni Yüzyıl Üniversitesi
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Merve BAT TONKUŞ

Lecturer

İstanbul Yeni Yüzyıl Üniversitesi

Study Sites (1)

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