NCT06518031

Brief Summary

A randomized controlled trial was conducted with nurses practicing meditation for six weeks, compared to a control group with no intervention. Stress and fatigue levels were measured using validated scales at baseline and post-intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 16, 2024

Last Update Submit

July 20, 2024

Conditions

Intensive Care Nurses

Keywords

MeditationStressFatigueIntensive Care NursesWell-being

Outcome Measures

Primary Outcomes (2)

  • STRESS LEVELS

    PERCEIVED STRESS SCALE

    after 6 weeks

  • FATIGUE LEVELS

    FATIGUE SEVERITY SCALE

    after 6 weeks

Study Arms (2)

Meditation Group

EXPERIMENTAL

Meditation practices were administered by the meditation expert for 6 weeks, three times a week for 20 minutes each session, totaling 60 minutes per week

Other: meditation

Control Group

NO INTERVENTION

The research data were collected using a Personal Information Form prepared by the researchers containing introductory information about the nurses, the Perceived Stress Scale for stress, and the Fatigue Severity Scale for fatigue.

Interventions

meditationOTHER

meditation practices were administered by the meditation expert for 6 weeks, three times a week for 20 minutes each session, totaling 60 minutes per week

Meditation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intensive care nurses with at least 1 year of experience in the intensive care unit.
  • Nurses without chronic obstructive pulmonary disease, heart failure, asthma, or other conditions that could hinder breathing exercises.
  • Nurses without hearing and communication issues, psychiatric diagnoses (e.g., major depression).
  • Nurses who have not attended meditation, yoga, or breathing exercise classes in the past six months.
  • Nurses willing to participate in the study were included in the sample.

You may not qualify if:

  • Nurses who do not attend at least one of the meditation sessions conducted by the meditation expert.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songül GÜNGÖR

Merkez, Osmani̇ye, 80010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Meditation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Lecturer

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 24, 2024

Study Start

December 19, 2021

Primary Completion

January 25, 2022

Study Completion

January 30, 2022

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Purpose and Scope: This IPD plan outlines how individual participant data from the study "The Effects of Meditation on Stress and Fatigue in Intensive Care Nurses" will be shared and utilized. The data will be made available for verification of the study's findings and for further analysis by relevant researchers and scientific communities. Data Protection and Privacy: Participant data will be stored in compliance with national and international regulations to protect confidentiality. Data will only be shared for research purposes, ensuring participant identities are protected. Data Sharing Procedures: Data will be provided upon request to researchers and relevant institutions seeking to verify study results. Use of the data will be subject to approval by relevant ethics committees and for purposes of data sharing. Analysis Procedures: Data will be analyzed according to pre-established protocols, and findings will be presented in scientific reports. The methodology of analysis and i

Locations

TU(1)