NCT05100537

Brief Summary

Purpose: This research was planned to determine the effect of mindfulness-based stress reduction program on reducing the stress level and emotion regulation of nursing students. Design: The research was planned as a pretest, posttest, follow-up and randomized controlled study in order to determine the effect of the mindfulness-based stress reduction program on the stress level and emotion regulation of nursing students. Hypotheses: H1: The perceived stress level scores of nursing students in the intervention group participating in the mindfulness-based stress reduction program will decrease compared to the nursing students in the control group. H2: The perceived stress level of the nursing students in the intervention group participating in the mindfulness-based stress reduction program will decrease according to their pretest scores. H3: Emotion regulation strategies of nursing students in the intervention group participating in the mindfulness-based stress reduction program will differ from the nursing students in the control group. H4: The posttest and follow-up emotion regulation strategies of nursing students in the intervention group participating in the mindfulness-based stress reduction program will differ from the pretest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

First Submitted

Initial submission to the registry

October 5, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

October 5, 2021

Last Update Submit

July 28, 2022

Conditions

Keywords

MindfulnessNursing student

Outcome Measures

Primary Outcomes (2)

  • Perceived Stress Scale

    The 14-item scale was designed to measure how stressful the individual perceives certain situations in his life. The scale is in 5-point Likert type, ranging from "Never (0)" to "Very often (4)". 7 of the scale items with positive expressions are scored in reverse. The total score from the scale indicates the stress level of the person. A score between 11-26 indicates a low stress level, a score between 27-41 indicates a medium stress level, and a score between 42-56 indicates a high stress level.

    For 3 months

  • Cognitive Emotion Regulation Scale

    It is a five-point Likert type scale (1 = not at all suitable for me, 2 = somewhat suitable for me, 3 = somewhat suitable for me, 4 = very suitable for me, 5 = completely suitable for me). The scale consists of 36 items in total. Cronbach's alpha value in the original form of the scale. with 67. It is between 81. The scale includes "self-blame", "acceptance", "focus on thought", "positive refocus", "plan refocus", "positive reconsideration", "perspective", "destruction" and "blaming others". It consists of nine sub-dimensions.

    For 3 months

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

The Mindfulness Based Stress Reduction program 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 120 minute sessions, once per week for eight weeks.

Behavioral: Mindfulness Based Stress Reduction

CONTROL GROUP

ACTIVE COMPARATOR

no intervention

Other: continuing a routine life

Interventions

The intervention has its roots in meditations and yoga practices. However, it is independent of religious purpose or affiliation.The weekly sessions include a range of mental and bodily practices, including awareness of emotions, awareness of thoughts, awareness of sensations. It involves full awareness of daily activities, using the breath as an anchor for attention.In addition to mindfulness practices and experiential work, psychoeducation and participants' sharing will clarify the issues of stress, stress management and how mindfulness is applied in daily situations and interpersonal communication.

Mindfulness Based Stress Reduction

No intervention will be made in the control group.

CONTROL GROUP

Eligibility Criteria

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

You may qualify if:

  • Age range is 18-25 years old
  • Being a student in the second or third year of the nursing department
  • Regular attendance at school
  • Not having a communication problem related to vision or hearing
  • It was determined as having a score of 26 or more from the perceived stress scale.

You may not qualify if:

  • Have a psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ece alagöz

Pendik, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emotional Regulation

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

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

October 5, 2021

First Posted

October 29, 2021

Study Start

November 1, 2021

Primary Completion

May 3, 2022

Study Completion

June 27, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations