NCT05634343

Brief Summary

Nurses working by shifts under intense stress and pressure and using complicated technological products- undergo fatigue and attention deficit with the effect of the many negative factors caused by work setting. This threatens patient and staff safety as well as leads to communicational problems, work absenteeism, lowered motivation, inability to control stress and poor work performance and productivity among nurses as well. In this sense; laughter therapy and mindfulness practices may help nurses cope with these problems because some experimental studies proved that both methods showed many benefits in different samples. However; no studies in which these two methods were compared among nurses were encountered. Therefore; the study -being in experimental design and randomized controlled trial- will be undertaken with a total of 111 nurses employed at a university hospital -37 nurses allocated to the experimental 1 group, 37 nurses to the experimental 2 group and 37 nurses to the control group-. First; Computer-Based Sustained Attention Test, the Stroop Test Çapa Version, The Chalder Fatigue Scale (CFQ) and Individual Work Performance Questionnaire will be administered to the nurses of the experimental and control groups as a pre-test. Then; nurses of the experimental 1 group will join sessions of laughter therapy (30-45 minutes twice a week for 8 weeks) and nurses of the experimental 2 group will join sessions of mindfulness practices (45-60 minutes twice a week for 8 weeks) for two months. One month later when the sessions are started, a mid test will be administered and soon after the sessions are completed a post test will be administered to the nurses via Computer-Based Sustained Attention Test, the Stroop Test Çapa Version, The Chalder Fatigue Scale (CFQ) and Individual Work Performance Questionnaire. One month later after the post test; a follow-up will be performed using the same tools. As a result; the effects of both applications on fatigue, attention and performance will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

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

September 6, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

November 18, 2022

Last Update Submit

August 20, 2024

Conditions

Keywords

Mindfulness, Attention, Laughter therapy, Job performance, Fatigue

Outcome Measures

Primary Outcomes (5)

  • Personal Information Form

    This form developed by the researcher consists of six questions about the characteristics of nurses.

    First day

  • Chalder Fatigue Scale

    The scale was developed in 1993 to measure the severity of fatigue. The scale has two sub-dimensions (physical and mental) and consists of 11 items. The total fatigue score is obtained by summing the scores of all items. Higher scores indicate greater severity of fatigue.

    First day

  • Computer-Based Sustainable Attention Test

    Developed in 2006, the test measures sustained attention at three levels: easy, medium and difficult. A minimum of 0 and a maximum of 10 are taken from each level. An increase in the test score indicates an increase in the level of sustained attention.

    First day

  • Stroop Test Çapa Form

    The Stroop form developed by Weintraub in 2000 was adapted to Turkish by Emek Savaş et al. The test is used to determine the selective attention and reaction time of individuals. In the test, there are two stimulus cards and a total of 60 items placed on each card in the order of 6 x 10. The first card contains small rectangles of red, green and blue, while the second card has color names written in mismatched ink colors. The Stroop test is one of the most frequently used tests in neuropsychological evaluation. The fact that it can be applied to people of all age groups in a short time increases the preferability of the test.

    First day

  • Individual Job Performance Scale

    The scale developed by Koopmans et al. in 2013 measures employee performance in three dimensions (task, contextual, counterproductive behaviour). The scale has 14 items and is a five-point Likert scale.

    First day

Secondary Outcomes (12)

  • Chalder Fatigue Scale

    At the end of the 1st month

  • Computer-Based Sustainable Attention Test

    At the end of the 1st month

  • Stroop Test Çapa Form

    At the end of the 1st month

  • Individual Job Performance Scale

    At the end of the 1st month

  • Chalder Fatigue Scale

    At the end of the 2st month

  • +7 more secondary outcomes

Study Arms (3)

experimental group 1

EXPERIMENTAL

The laughter therapy program consists of 16 sessions, twice a week for eight weeks. Each session; It is planned to last 30-45 minutes with a maximum of 25 nurses.

Other: experimental group 1

experimental group 2

EXPERIMENTAL

The mindfulness practice program consists of 16 sessions, twice a week for eight weeks. Each session is planned to last 45-60 minutes with a maximum of 25 nurses.

Other: experimantal group 2

Control Group

NO INTERVENTION

No intervention was made in the control group.

Interventions

Laughter therapy, also called therapeutic laughter, is used to relieve pain and stress and to promote a general sense of well-being. Laughter therapy is simply a method of 'laughing for no reason' in which the person interacts in a group setting with improvisation or pantomime-like exercises and childish games without humour, jokes or funny events. The aim is thus to benefit from laughter.

experimental group 1

Mindfulness is purposefully drawing attention in the desired direction so that we can stay in the present moment without judgment. It is also defined as a conscious understanding of what is happening in the moment we live in with an open and loving attitude. According to another definition, mindfulness includes paying attention to what is happening in the present moment, noticing the quality of this attention, and accepting what is noticed without judgment. With conscious awareness, the individual discovers how to live in harmony with all the events that take place in the present moment, place and time, without any evaluation, rather than the sorrows and regrets of the past, the anxieties and worries of the future. Mindfulness helps us to relate to our experiences by enabling us to see the positive-negative, good-bad experiences we have had objectively.

experimental group 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • at least 6 months experience
  • volunteering
  • alternative work schedule

You may not qualify if:

  • Not being a nurse,
  • Pregnancy
  • Diagnosis of colour blindness, cardiovascular, psychological diseases
  • Meditating before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayburt University

Bayburt, Turkey (Türkiye)

Location

Related Publications (1)

  • Koroglu Kaba N, Ozturk H. The Effects of Laughter Yoga and Mindfulness on Nurses' Fatigue, Work Performance and Attention Levels: A Randomized Controlled Study. Clin Nurse Spec. 2025 Nov-Dec 01;39(6):260-268. doi: 10.1097/NUR.0000000000000927.

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Simple random numbers table was used to determine the nurses to be sampled. 673 nurses working in KTU Farabi Hospital were listed and numbered, and the starting point was chosen from the random numbers table, followed by the columns downwards, and the sample number was reached. If the sample could not be reached due to reasons such as the criteria were not met or the research invitation was not accepted, the sample selection was continued from the random numbers table until the sample number was reached. Then, in order to create homogeneous groups in the assignment of nurses to the experimental and control groups, equal numbers of triple groups were formed by matching according to the unit/service (internal, surgical, specialized unit) and professional experience (10 years and below, 11 years and above).
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research examines the effects of laughter and mindfulness on some parameters (fatigue, performance and attention) in nurses.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 2, 2022

Study Start

September 6, 2021

Primary Completion

April 20, 2022

Study Completion

October 20, 2022

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations