NCT05653375

Brief Summary

Purpose: The fact that young people starting university during the pandemic period continue this academic period with distance education increases the stress they experience. Therefore, the purpose of this study is to determine the effect of mindfulness-based psychoeducation program applied with distance education on the psychological well-being, emotional intelligence, and stress levels of youth. Method: This study was conducted in a randomized controlled manner with a pretest-posttest control group random design model. The population of the study consisted of 120 newly enrolled students in the nursing department of a foundation university, and the sample consisted of a total of 59 students who met the inclusion criteria of the study. In the sample, while 29 students formed the intervention group, 30 students formed the control group. Mindfulness-Based Psychoeducation Program (MBPP) was applied to the intervention group twice a week for 4 weeks. Perceived Stress Scale (PSS-14), Psychological Well-Being Scale (PWB), and Revised Schutte Emotional Intelligence Scale (SEIS) were used as measurement tools. Further, t-test, Mann Whitney U analysis, and Wilcoxon signed-row test were used in the analysis of the data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

22 days

First QC Date

December 6, 2022

Last Update Submit

December 15, 2022

Conditions

Keywords

Minfulnessstressemotional intelligencepsychological well-beingnursing

Outcome Measures

Primary Outcomes (3)

  • Change of psychological well-being after 4 weeks.

    Psychological Well-Being Scale: The items of the Psychological Well-Being Scale are answered between 1 and 7, as strongly disagree (1) to strongly agree (7). Scores range from 8 to 56. A high score indicates that the person has many psychological resources and strengths.

    baseline and 4 weeks.

  • Change of emotional intelligence level after 4 weeks.

    Revised Schutte Emotional Intelligence Scale: The scale, which was studied using the total score, has three sub-dimensions and consists of 41 items. It is a Likert-type scale with items scored between 1 and 5 (1: Never, 5: Always). If the total score of the scale is high, it means that the level of emotional intelligence is also high.

    baseline and 4 weeks.

  • Change of perceived stress level after 4 weeks.

    Perceived Stress Scale: Consisting of 14 items in total, PSS-14 is designed to measure how stressful situations in a person's life are perceived. The scores of the PSS-14 vary between 0 and 56, and the high score indicates a high perception of stress (cut-off point \> 25).

    baseline and 4 weeks.

Study Arms (2)

mindfulness-based psychoeducation program

EXPERIMENTAL

The group in which the mindfulness-based psychoeducation program was applied.

Other: Mindfulness-based psychoeducation program

control group

ACTIVE COMPARATOR

The group in which no intervention was made and only the pre-test and post-test were applied for comparison.

Other: ongoing life

Interventions

In this study, a mindfulness-based psychoeducation program was applied to the experimental group, 2 times a week for 4 weeks, with a total of 8 sessions, including methods such as meditation, body scanning, mindful eating, and breathing work. Measurement tools were applied to the experimental and control groups before and after the program.

mindfulness-based psychoeducation program

The control group continued with their lives without any intervention. Only pre-test and post-test were applied. While the program was applied to the experimental group, no intervention was made to the control group.

control group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Over 18 years old,
  • Without a psychiatric diagnosis,
  • Have not done awareness practices before,
  • Not meditating,
  • Not a foreign national,
  • Those who score moderately and above on the Perceived Stress Scale
  • Those who volunteered to participate in the study

You may not qualify if:

  • Those who scored less than 25 on the perceived stress scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University

Istanbul, 34857, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozturk S. The effect of a distance-delivered mindfulness-based psychoeducation program on the psychological well-being, emotional intelligence and stress levels of nursing students in Turkey: a randomized controlled study. Health Educ Res. 2023 Dec 11;38(6):575-586. doi: 10.1093/her/cyad040.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

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
Assistant Professor

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 16, 2022

Study Start

January 10, 2021

Primary Completion

February 1, 2021

Study Completion

September 30, 2021

Last Updated

December 16, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations