Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05653375 |
Other study ID # |
2021/01-11 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 10, 2021 |
Est. completion date |
September 30, 2021 |
Study information
Verified date |
December 2022 |
Source |
Maltepe University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Population-Sample: The population of this study consisted of 1st grade students registered at
Maltepe University School of Nursing in the 2020-2021 academic year. 64 students who met the
criteria for participating in the study (over 18 years of age, without a psychiatric
diagnosis, who did not practice mindfulness before, who did not meditate, whose mother tongue
was Turkish, who scored above the cut-off point (25˂) in the perceived stress scale) and
declared their willingness to be a voluntary participant formed the sample. G*Power 3.1.9.2
program was used to estimate the number of samples (Faul, Erdfelder, Lang et al. (2007). In
order to calculate the effect size in power analysis, the relevant literature was examined
and the study by Yılmaz (2021) was taken as a basis. The effect size value (Cohen's d)
calculated with the emotional intelligence score averages and standard deviations
(intervention group= 92.73 ± 13.01; control group = 81.80 ± 8.95) of the intervention and
control groups presented in Yılmaz's (2021) study was calculated as .98. In this study, it
was determined that, for the one-tailed hypothesis, the minimum number of samples to be
included in the study with an effect size of .98, a margin of error of 0.05, and a power of
0.95 should be 48 people in total, 24 for each group (intervention group = 24; control group
= 24). Participants were numbered from 1 to 64, and 32 intervention and 32 control groups
were created from the www.random.org site, taking into account the possibility of data loss.
During the application process, 2 people from the intervention group did not want to continue
after the first session, 1 person had long-term internet connection problems, and 2 people
from the control group did not fill out the second measurement forms (drop out). The study
was completed as 29 intervention and 30 control groups.
Data collection and program application:
Before starting the research, the ethics committee decision dated 08/01/2021 and numbered
2021/01-11 was taken from X Ethics Committee. Data were collected online via google forms. On
the first day of the application, other scales except the Perceived Stress Scale were applied
simultaneously to the intervention and control groups. The intervention group was given a
program for 4 weeks, with 2 sessions per week and each session 90 minutes. At the end of the
program, data collection tools were applied to both groups simultaneously again. During this
period, no application was made to the control group.