NCT05606861

Brief Summary

The aim of the study was to evaluate the effect of the Mindfulness Stress Reduction Intervention on increasing the psychological resilience of pediatric nurses. Design: This is a single-center, single-blind, randomized controlled trial Method: In the study, the group in which the Mindfulness-Based Stress Reduction Initiative was applied was taken as the experimental (n: 15), the unstructured group (n: 14) in which the stressful life experiences were shared as the control group. Due to the limited number of the research population (N:56), 29 nurses who agreed to participate in the study and met the inclusion criteria were included in the study without using the sampling method. This research was conducted with pediatric nurses working in the inpatient units of a children's hospital affiliated to a university in Izmir. Stress reduction training based on mindfulness, including meditation and breathing techniques, was given to the experimental group for 5 weeks. No intervention was applied to the control group. The primary outcomes of the study were measured using the Perceived Stress Scale, the Self-Compassion Scale, the Interpersonal Reactivity Index, and Psychological Resilience Scale for Adults. This study is important because it is the first randomized controlled study on the effect of Mindfulness Based Stress Reduction (MBSR) on resilience in nurses in our country. In addition, the results will contribute to preventing nurses from leaving the profession in the early period, providing more flexibility and therefore safe patient care to the nursing workforce, especially in today's health system where there is a heavy nursing shortage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

October 25, 2022

Last Update Submit

November 3, 2022

Conditions

Keywords

Pediatric NursePsychological ResilienceMindfulness

Outcome Measures

Primary Outcomes (4)

  • Perceived Stress Level

    Perceived Stress Scale:The lowest score which can be obtained on the scale is 0, and the highest is 56.Higher total score means higher perceived stress level.

    For 9 weeks

  • Psychological Resilience Level

    Psychological Resilience Scale for Adults: The minimum score on the scale is 33, and the maximum is 165. A low score on the scale indicates that the person's psychological resilience level is inadequate.

    For 9 weeks

  • Empathy Level

    Interpersonal Reactivity Index: The scale measures different aspects of empathy. For example, the perspective-taking dimension expresses better interpersonal functioning and higher self-esteem, while the empathetic thinking dimension expresses a consistent relationship with social competence or self-esteem.

    For 9 weeks

  • Self Compassion Level

    The Self-Compassion Scale consists of 26 Likert type items and six sub-dimensions.A higher total score on the scale indicates a higher level of self-compassion perceived by the participants.

    For 9 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Mindfulness Based Intervention in pediatric nurses components was applied to this group.

Other: Mindfulness Based Interventions in Pediatric Nurses

Control group

NO INTERVENTION

No procedure was conducted the control group.

Interventions

This intervention are structured mindfulness program including meditation and breathing techniques .

Intervention group

Eligibility Criteria

Age18 Years - 58 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Working for at least one year in the children's ward,
  • Older than 18 years of age,
  • The working program must be suitable for the experiment schedule.

You may not qualify if:

  • Clinical diagnosis for a psychiatric disorder,
  • Long experience of meditation or yoga.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Hospital

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health Behavior

Interventions

Nurses, Pediatric

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Nurse SpecialistsNursesHealth PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 25, 2022

First Posted

November 7, 2022

Study Start

November 20, 2018

Primary Completion

December 28, 2018

Study Completion

January 30, 2019

Last Updated

November 7, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations