Breathing ExercisesNCT06642376
The Effect of Breathing Exercise Applied to Intensive Care Nurses on Fatigue and Perceived Stress
A study testing Experimental: Breathing Exercise Application Group in people with Breathing Exercises and Critical Care Nursing, run by Kahramanmaraş İstiklal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breathing Exercises, Critical Care Nursing
- What is being tested?
- Experimental: Breathing Exercise Application Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having a problem that prevents nasal breathing and prevents breathing exercises
- Being pregnant
- Experiencing physical and mental health problems that prevent communication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaraş Istiklal Universty
Kahramanmaraş
Yasemin SAZAK, 05414474944
yasemin.sazak@istiklal.edu.tr
About this study
Official title: The Effect of Breathing Exercise Applied to Intensive Care Nurses on Fatigue and Perceived Stress: A Randomized Controlled Study
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.
Read more
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.
Read the detailed description
In line with the randomization list, nurses will be assigned to the intervention and control groups in line with the inclusion criteria. The nurses will be informed about the study and their written and verbal consent will be obtained to participate in the study. Data will be collected from the nurses in the intervention and control groups with a pre-test data collection form. The nurses in the intervention group will be given breathing exercise practice, while the patients in the control group will not be subjected to any intervention. In the research; triple breathing technique (full yogic breathing) and 4-7-8 breathing technique will be used. In the intervention group, the nurses will first be told face-to-face about the breathing practice and have them do it. Then, face-to-face practice will be done three days a week, and on the other days, an audio recording of the breathing exercise will be sent by the researcher to the nurses via WhatsApp and they will be practiced daily. Breathing exercise will continue for 30 days in the intervention group. Follow-up data will be collected from the control and intervention group on the 15th day as an interim follow-up (with Piper fatigue scale and perceived stress scale). On the 30th day, the research will be finalized by collecting the post-test data. At the end of the study, the nurses in the control group will be shown and practiced breathing exercises.
- Conditions
- Breathing Exercises, Critical Care Nursing
- Being tested
- Experimental: Breathing Exercise Application Group
- Keywords
- Stress, Nurse, Intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Breathing Exercise Application GroupBehavioural
The Effect of Breathing Exercise Applied to Intensive Care Nurses on Fatigue and Perceived Stress
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Experimental: Breathing Exercise Application Group |
| Control group | No intervention | There will be no intervention for individuals in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start21 Oct 2024
- Primary completion10 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaraş İstiklal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Sazak, Kahramanmaraş İstiklal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642376
- Sponsor's protocol ID
- IstiklalU-YSazak-002
- Status last verified
- Dec 2024
- First submitted
- 12 Oct 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercise Applied to Intensive Care Nurses on Fatigue and Perceived Stress: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06642376
- Acronym / sponsor ID
- IstiklalU-YSazak-002
- Conditions
- Breathing Exercises, Critical Care Nursing
- Keywords
- Stress, Nurse, Intensive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kahramanmaraş İstiklal UniversityUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In line with the randomization list, nurses will be assigned to the intervention and control groups in line with the inclusion criteria. The nurses will be informed about the study and their written and verbal consent will be obtained to participate in the study. Data will be collected from the nurses in the intervention and control groups with a pre-test data collection form. The nurses in the intervention group will be given breathing exercise practice, while the patients in the control group will not be subjected to any intervention. In the research; triple breathing technique (full yogic breathing) and 4-7-8 breathing technique will be used. In the intervention group, the nurses will first be told face-to-face about the breathing practice and have them do it. Then, face-to-face practice will be done three days a week, and on the other days, an audio recording of the breathing exercise will be sent by the researcher to the nurses via WhatsApp and they will be practiced daily. Breathing exercise will continue for 30 days in the intervention group. Follow-up data will be collected from the control and intervention group on the 15th day as an interim follow-up (with Piper fatigue scale and perceived stress scale). On the 30th day, the research will be finalized by collecting the post-test data. At the end of the study, the nurses in the control group will be shown and practiced breathing exercises.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Application Group | Experimental | Behavioral: Experimental: Breathing Exercise Application GroupNurses 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. |
| Control group | No intervention | –There will be no intervention for individuals in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Having a problem that prevents nasal breathing and prevents breathing exercises
- Being pregnant
- Experiencing physical and mental health problems that prevent communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Breathing Exercise Application GroupThe Effect of Breathing Exercise Applied to Intensive Care Nurses on Fatigue and Perceived Stress | Behavioural | Breathing Exercise Application Group |
Primary outcome
Piper Fatigue Scale
Time frame: 0 days
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.
Piper Fatigue Scale
Time frame: 15 days
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.
Piper Fatigue Scale
Time frame: 30 days
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.
Perceived Stress Scale
Time frame: 0 days
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.
Perceived Stress Scale
Time frame: 15 days
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.
Perceived Stress Scale
Time frame: 30 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Breathing Exercise Application Group in people with Breathing Exercises and Critical Care Nursing, run by Kahramanmaraş İstiklal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasemin SAZAK (05414474944, yasemin.sazak@istiklal.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Piper Fatigue Scale (time frame: 0 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.