StressNCT05337800
Stress Management on Nursing Students
A study testing stress managment program in people with Stress and Clinical Anxiety, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to determine the effect of the stress management program on the clinical stress of first year nursing students. This research will be carried out in a randomized controlled experimental design. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Clinical Anxiety
- What is being tested?
- stress managment program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 26 May 2022
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The first to enroll in the Nursing Fundamentals course,
Who cannot join
- Have previously taken nursing fundamentals course
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Stress Management Program on Clinical Stress of First Year Nursing Students
In this study, it was aimed to determine the effect of the stress management program on the clinical stress of first year nursing students. This research will be carried out in a randomized controlled experimental design.
The data of the research; The descriptive characteristics form will be collected using the Perceived Stress Scale for Nursing Students, the Bio-Psycho-Social Response Scale for Nursing Students, and the Stress Coping Behaviors Scale for Nursing Students. students will be assigned as experiment (32) and control (32) by randomization. A four-session stress management program will be applied to the experimental group students. No intervention will be made on the control group.
- Conditions
- Stress, Clinical Anxiety
- Being tested
- stress managment program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress managment programBehavioural
A four-session stress management program will be applied to the experimental group students.
| Study group | Role | What they receive |
|---|---|---|
| stress management program | Experimental | Not described Receives: Behavioral: stress managment program |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale for Nursing Students
It measures the perceived stress of nursing students. It is a Likert type scale and consists of 29 items. Total score; 0 - 116. A high score indicates a higher level of stress.
Measured: 15 minute
Bio-Psycho-Social Response Scale for Nursing Students
It consists of 21 items related to the symptoms related to the physical, psychological and social health of students. It is a Likert type scale and consists of 21 items. Total score; It ranges from 0 to 84. A high score indicates more symptom presence and poor bio-psycho-social status.
Measured: 20 minute
Stress Coping Behaviors Scale for Nursing Students
It measures the stress coping behaviors of students. It consists of 19 items in total. A higher score on a factor indicates that this coping type is used more frequently.
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Mar 2022
- Primary completion28 Mar 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Gülnar, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337800
- Sponsor's protocol ID
- KirikkaleU12345
- Status last verified
- Mar 2024
- First submitted
- 7 Apr 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mackenzie CS, Poulin PA, Seidman-Carlson R. A brief mindfulness-based stress reduction intervention for nurses and nurse aides. Appl Nurs Res. 2006 May;19(2):105-9. doi: 10.1016/j.apnr.2005.08.002.
PubMed 16728295Botha E, Gwin T, Purpora C. The effectiveness of mindfulness based programs in reducing stress experienced by nurses in adult hospital settings: a systematic review of quantitative evidence protocol. JBI Database System Rev Implement Rep. 2015 Oct;13(10):21-9. doi: 10.11124/jbisrir-2015-2380.
PubMed 26571279Karaca A, Sisman NY. Effects of a Stress Management Training Program With Mindfulness-Based Stress Reduction. J Nurs Educ. 2019 May 1;58(5):273-280. doi: 10.3928/01484834-20190422-05.
PubMed 31039261
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Management Program on Clinical Stress of First Year Nursing Students
- ClinicalTrials.gov ID
- NCT05337800
- Acronym / sponsor ID
- KirikkaleU12345
- Conditions
- Stress, Clinical Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 20 Apr 2022 (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.
In this study, it was aimed to determine the effect of the stress management program on the clinical stress of first year nursing students. This research will be carried out in a randomized controlled experimental design.
The data of the research; The descriptive characteristics form will be collected using the Perceived Stress Scale for Nursing Students, the Bio-Psycho-Social Response Scale for Nursing Students, and the Stress Coping Behaviors Scale for Nursing Students. students will be assigned as experiment (32) and control (32) by randomization. A four-session stress management program will be applied to the experimental group students. No intervention will be made on the control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stress management program | Experimental | Behavioral: stress managment program |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The first to enroll in the Nursing Fundamentals course,
Key exclusion criteria (1 listed)
- Have previously taken nursing fundamentals course
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 |
|---|---|---|
| stress managment programA four-session stress management program will be applied to the experimental group students. | Behavioural | stress management program |
Primary outcome
Perceived Stress Scale for Nursing Students
Time frame: 15 minute
It measures the perceived stress of nursing students. It is a Likert type scale and consists of 29 items. Total score; 0 - 116. A high score indicates a higher level of stress.
Bio-Psycho-Social Response Scale for Nursing Students
Time frame: 20 minute
It consists of 21 items related to the symptoms related to the physical, psychological and social health of students. It is a Likert type scale and consists of 21 items. Total score; It ranges from 0 to 84. A high score indicates more symptom presence and poor bio-psycho-social status.
Stress Coping Behaviors Scale for Nursing Students
Time frame: 15 minute
It measures the stress coping behaviors of students. It consists of 19 items in total. A higher score on a factor indicates that this coping type is used more frequently.
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 5 Mar 2024.
- Background: PubMed 16728295Mackenzie CS, Poulin PA, Seidman-Carlson R. A brief mindfulness-based stress reduction intervention for nurses and nurse aides. Appl Nurs Res. 2006 May;19(2):105-9. doi: 10.1016/j.apnr.2005.08.002.
- Background: PubMed 26571279Botha E, Gwin T, Purpora C. The effectiveness of mindfulness based programs in reducing stress experienced by nurses in adult hospital settings: a systematic review of quantitative evidence protocol. JBI Database System Rev Implement Rep. 2015 Oct;13(10):21-9. doi: 10.11124/jbisrir-2015-2380.
- Background: PubMed 31039261Karaca A, Sisman NY. Effects of a Stress Management Training Program With Mindfulness-Based Stress Reduction. J Nurs Educ. 2019 May 1;58(5):273-280. doi: 10.3928/01484834-20190422-05.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress managment program in people with Stress and Clinical Anxiety, run by Kırıkkale 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 1 inclusion and 1 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 5 Mar 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?
Perceived Stress Scale for Nursing Students (time frame: 15 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05337800, which also lists 3 linked publications.
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 Mar 2024.