NCT06642376

Brief Summary

The aim of this randomized controlled trial was to investigate the effect of breathing exercise on fatigue and stress in intensive care nurses. Hypotheses of the study; H11: The level of perceived stress in nurses practicing breathing exercise is lower than the nurses in the control group. H12: The level of fatigue is lower in nurses practicing breathing exercise compared to nurses in the control group. Data will be collected in the intervention and control groups with a pre-test data collection form before the intervention. Patients in the intervention group will be given breathing exercises, while patients in the control group will not receive any intervention. In the second week, interim follow-up data will be collected with the data collection form. At the end of the study; data will be collected from the intervention and control groups with post-test data collection forms.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 12, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

October 12, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

StressNurseIntensive care

Outcome Measures

Primary Outcomes (6)

  • Piper Fatigue Scale

    The scale was developed by Piper et al. in 1987 to assess fatigue with the "integrated fatigue model". The Turkish validity and reliability study of the scale was conducted by Can et al. in 2004. The PMS consists of a total of 22 items, each rated on a 0-10 point Visual Analog Scale (VAS), and four sub-dimensions that assess the patient's subjective perception of fatigue.

    0 days

  • Piper Fatigue Scale

    The scale was developed by Piper et al. in 1987 to assess fatigue with the "integrated fatigue model". The Turkish validity and reliability study of the scale was conducted by Can et al. in 2004. The PMS consists of a total of 22 items, each rated on a 0-10 point Visual Analog Scale (VAS), and four sub-dimensions that assess the patient's subjective perception of fatigue.

    15 days

  • Piper Fatigue Scale

    The scale was developed by Piper et al. in 1987 to assess fatigue with the "integrated fatigue model". The Turkish validity and reliability study of the scale was conducted by Can et al. in 2004. The PMS consists of a total of 22 items, each rated on a 0-10 point Visual Analog Scale (VAS), and four sub-dimensions that assess the patient's subjective perception of fatigue.

    30 days

  • Perceived Stress Scale

    The Perceived Stress Scale was developed by Cohen, Kamarck and Mermelstein in 1983 and was designed to measure the extent to which people perceive the situations in their lives as stressful. The Turkish validity and reliability study of the scale was conducted by Mehmet Eskin et al. in 2013. It consists of 14 items and 2 sub-dimensions. In the 14-item perceived stress scale, scores range from 0 to 56. A high score in the questionnaire indicates a high perception of stress.

    0 days

  • Perceived Stress Scale

    The Perceived Stress Scale was developed by Cohen, Kamarck and Mermelstein in 1983 and was designed to measure the extent to which people perceive the situations in their lives as stressful. The Turkish validity and reliability study of the scale was conducted by Mehmet Eskin et al. in 2013. It consists of 14 items and 2 sub-dimensions. In the 14-item perceived stress scale, scores range from 0 to 56. A high score in the questionnaire indicates a high perception of stress.

    15 days

  • Perceived Stress Scale

    The Perceived Stress Scale was developed by Cohen, Kamarck and Mermelstein in 1983 and was designed to measure the extent to which people perceive the situations in their lives as stressful. The Turkish validity and reliability study of the scale was conducted by Mehmet Eskin et al. in 2013. It consists of 14 items and 2 sub-dimensions. In the 14-item perceived stress scale, scores range from 0 to 56. A high score in the questionnaire indicates a high perception of stress.

    30 days

Study Arms (2)

Breathing Exercise Application Group

EXPERIMENTAL

Nurses in the intervention group will be made to practice breathing exercises. The breathing exercise will first be explained to the nurses face-to-face and they will be made to do it. Then, face-to-face practice will be done three days a week, and on the other days, the audio recording of the breathing exercise will be sent by the researcher to the nurses via WhatsApp and they will be practiced daily. The breathing exercise will continue for 30 days.

Behavioral: Experimental: Breathing Exercise Application Group

Control group

NO INTERVENTION

There will be no intervention for individuals in this group.

Interventions

The Effect of Breathing Exercise Applied to Intensive Care Nurses on Fatigue and Perceived Stress

Breathing Exercise Application Group

Eligibility Criteria

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

You may qualify if:

  • Working in intensive care for at least 6 months
  • Volunteering to participate in the research
  • Not practicing any complementary therapies during the study, such as breathing exercises, acupuncture, massage therapy, relaxation techniques and yoga, which may be effective on perceived stress and fatigue

You may not qualify if:

  • Having a problem that prevents nasal breathing and prevents breathing exercises
  • Being pregnant
  • Experiencing physical and mental health problems that prevent communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Istiklal Universty

Kahramanmaraş, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 12, 2024

First Posted

October 15, 2024

Study Start

October 21, 2024

Primary Completion

December 10, 2024

Study Completion

January 15, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations