Nursing StudentsNCT06103344
The Effect of 4-7-8 Breathing Exercise Training on Sleep Quality
A study testing 4-7-8 Breathing Exercise Training in people with Nursing Students, run by Uğur Doğan at 1 site in Turkey (Türkiye).
Trial summary
Research; it will be carried out Kilis 7 Aralik University Yusuf Serefoglu Health Sciences Faculty, Department of Nursing. The training will take approximately 20 minutes in an empty classroom and will be planned when the students' classes finish. Thus, educational activities in the institution will not be disrupted. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nursing Students
- What is being tested?
- 4-7-8 Breathing Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2023to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteer
- Studying in a nursing undergraduate program
- There is no condition that prevents nasal breathing (such as septal deviation)
- No known chronic sleeping disorder
Who cannot join
- No studying in a nursing undergraduate program
- There is condition that prevents nasal breathing (such as septal deviation)
- Having any chronic sleeping disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kilis 7 Aralık University
Kilis, Center, 79100
About this study
Official title: The Effect of 4-7-8 Breathing Exercise Training Given to Nursing Students on Sleep Quality: A Randomized-controlled Study
Research; it will be carried out Kilis 7 Aralik University Yusuf Serefoglu Health Sciences Faculty, Department of Nursing. The training will take approximately 20 minutes in an empty classroom and will be planned when the students' classes finish. Thus, educational activities in the institution will not be disrupted. Participants will be asked to do the taught exercise in half an hour before going to sleep every evening during the research period (4 weeks). Training will begin when the determined number of samples is reached. The training will be terminated when the 4-week research period determined to see the effect of the application expires.
- Conditions
- Nursing Students
- Being tested
- 4-7-8 Breathing Exercise Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-7-8 Breathing Exercise TrainingBehavioural
Participants in the intervention group will be taught 4-7-8 breathing exercises collectively, and the training will be repeated on specified days (twice a week for a total of 4 weeks). During the training, it will be checked whether each participant in the intervention group can perform the breathing exercise correctly and feedback will be given. Participants who fail to implement the exercise will be excluded from the study. 4-7-8 breathing exercise training, prepared in accordance with the literature, will be given by the assistant researcher who has training and certification in breathing exercises. Training will be planned in an empty classroom, for approximately 20 minutes and at the students' end time. Thus, educational activities in the institution will not be disrupted.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: 4-7-8 Breathing Exercise Training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index evaluates sleep quality in the last month, contains a total of 24 questions.
Measured: This measurement will be repeated at the beginning of the study and at the end of the 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start4 Dec 2023
- Primary completion17 Jan 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing StudentsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uğur Doğan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Uğur Doğan, Kilis 7 Aralik University
- Investigators
- Uğur Doğan, PhD, Study chair, Kilis 7 Aralik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103344
- Sponsor's protocol ID
- Kilis7AralikU-02
- Status last verified
- Apr 2024
- First submitted
- 23 Oct 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 4-7-8 Breathing Exercise Training Given to Nursing Students on Sleep Quality: A Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT06103344
- Acronym / sponsor ID
- Kilis7AralikU-02
- Conditions
- Nursing Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Uğur DoğanUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 26 Oct 2023 (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.
Research; it will be carried out Kilis 7 Aralik University Yusuf Serefoglu Health Sciences Faculty, Department of Nursing. The training will take approximately 20 minutes in an empty classroom and will be planned when the students' classes finish. Thus, educational activities in the institution will not be disrupted. Participants will be asked to do the taught exercise in half an hour before going to sleep every evening during the research period (4 weeks). Training will begin when the determined number of samples is reached. The training will be terminated when the 4-week research period determined to see the effect of the application expires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: 4-7-8 Breathing Exercise Training |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteer
- Studying in a nursing undergraduate program
- There is no condition that prevents nasal breathing (such as septal deviation)
- No known chronic sleeping disorder
Key exclusion criteria (3 listed)
- No studying in a nursing undergraduate program
- There is condition that prevents nasal breathing (such as septal deviation)
- Having any chronic sleeping disorder
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 |
|---|---|---|
| 4-7-8 Breathing Exercise TrainingParticipants in the intervention group will be taught 4-7-8 breathing exercises collectively, and the training will be repeated on specified days (twice a week for a total of 4 weeks). During the training, it will be checked whether each participant in the intervention group can perform the breathing exercise correctly and feedback will be given. Participants who fail to implement the exercise will be excluded from the study. 4-7-8 breathing exercise training, prepared in accordance with the literature, will be given by the assistant researcher who has training and certification in breathing exercises. Training will be planned in an empty classroom, for approximately 20 minutes and at the students' end time. Thus, educational activities in the institution will not be disrupted. | Behavioural | Intervention |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: This measurement will be repeated at the beginning of the study and at the end of the 4th week.
Pittsburgh Sleep Quality Index evaluates sleep quality in the last month, contains a total of 24 questions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Uğur Doğan, PhD study chair
Kilis 7 Aralik University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-7-8 Breathing Exercise Training in people with Nursing Students, run by Uğur Doğan 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 4 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: finished, as of the sponsor's last update on 25 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: This measurement will be repeated at the beginning of the study and at the end of the 4th week.). 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 25 Apr 2024.