NCT05296616

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 17, 2022

Last Update Submit

March 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Stress Level

    for 8 months

  • Heart Rate Variability

    for 8 months

Study Arms (2)

MSQSLHRV

EXPERIMENTAL

The group in which the mindfulness-based stress reduction intervention will be implemented.

Behavioral: Mindfulness Based Stress Reduction Intervention

Control

NO INTERVENTION

The group to which mindfulness-based stress reduction intervention will not be applied

Interventions

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.

MSQSLHRV

Eligibility Criteria

Age17 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being a student of the relevant faculty,
  • No barriers to accessing technology for participation in the online program,
  • No visual or hearing impairment

You may not qualify if:

  • Not being a student of the relevant faculty,
  • Having barriers to accessing technology for participation in the online program,
  • Having visual or hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merve Bat Tonkus

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Merve Bat Tonkus, PhD Cand

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 17, 2022

First Posted

March 25, 2022

Study Start

May 18, 2022

Primary Completion

November 18, 2022

Study Completion

January 18, 2023

Last Updated

April 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations