NCT05129579

Brief Summary

Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on the psychological resilience and well-being of intensive care nurses. 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 resilience level scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to the nurses in the control group. H2: Nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase their well-being level scores compared to the nurses in the control group. H3: The psychological resilience level posttest and follow-up scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to their pretest scores. H4: The well-being level posttest and follow-up scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

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

October 28, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

October 28, 2021

Last Update Submit

November 9, 2021

Conditions

Keywords

MindfulnessIntensive Care Nurses

Outcome Measures

Primary Outcomes (2)

  • Psychological Resilience Level

    Psychological Resilience Scale for Adults: The scale consists of 33 items; it includes 6 sub-dimensions: The structural style (3,9,15,21) and perception of future (2,8,14,20) subdimensions were measured by 4 items each, the family cohesion (5,11,17,23,26,32), perception of self (1,7,13,19,28,31,), and social competence (4,10,16,22,25,29) sub-dimensions were measured by 6 items each, and the social resources (6,12,18,24,27,30,33) sub-dimension was measured by 7 items. The score that can be obtained from the scale varies from 33 to 165.

    for 3 months

  • Psychological Well-being Level

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

    for 3 months

Study Arms (2)

MBRSEG

EXPERIMENTAL

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

Behavioral: Mindfulness Based Stress Reduction Intervention

control group

OTHER

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

Other: no intervention

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.

MBRSEG

No intervention will be made in the control group.

control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having Having a working time of at least 6 months in the intensive care unit,
  • No barriers to accessing technology for participation in the online training program,
  • Absence of a communication barrier related to vision and hearing

You may not qualify if:

  • Working in the intensive care unit for less than 6 months
  • Working in the intensive care unit due to temporary assignment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, PhD Cand.

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 22, 2021

Study Start

November 1, 2021

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

November 22, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share