AnxietyNCT05326685
The Effect of Visual Video With Korotkoff Sounds on Blood Pressure Measurement Skills and Anxiety Levels
A study testing video with korotkoff sounds in people with Anxiety, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Background: The aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels. Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- video with korotkoff sounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2022to 27 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Studying in the first year of the nursing department in the 2021-2022 academic year,
- Taking the "pulse and blood pressure measurement" course and laboratory practice
- Students who agree to participate in the study will be included.
Who cannot join
- Previous manual blood pressure measurement experience,
- Those who do not participate in the theoretical part of the "pulse and blood pressure measurement" course,
- Students who do not attend the lesson on the day of the applications will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Visual Video With Korotkoff Sounds on Blood Pressure Measurement Skills and Anxiety Levels: A Randomized Controlled Study
Background: The aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels.
Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. Intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. Aural and visual video containing Korotkoff sounds were shown to the students before the practice.
Read the detailed description
Background: The aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels.
Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. Intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. Aural and visual video containing Korotkoff sounds were shown to the students before the practice. The data of the research were collected with the State-Trait Anxiety Inventory short version (STAIS-5, STAIT-5) and the Student introduction form.
- Conditions
- Anxiety
- Being tested
- video with korotkoff sounds
- Keywords
- Anxiety, Blood Pressure Measurement Skills, Korotkoff sounds, Nursing students
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video with korotkoff soundsOther
The State-Trait Anxiety Inventory short version (STAIS-5, STAIT-5) and the student introduction form were applied at the beginning of the study. Then Intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. Afterwards, blood pressure was measured to the students 3 times and 3 measurements were recorded. After the application about 2 hours later, the students State Anxiety Inventory short version (STAIS-5) form was filled again by students.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | video with korotkoff sounds Receives: Other: video with korotkoff sounds |
| Control | No intervention | standart practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The State-Trait Anxiety Inventory (STAIS-5, STAIT-5)
State-Trait Anxiety Inventory short version (STAIS-5, STAIT-5)[ Time Frame: pre-intervention ] The STAI consists of two parts; the State Anxiety Inventory (SAI) and the Trait Anxiety Inventory (TAI). The SAI measures anxiety about an event while the TAI measures anxiety level as a personal characteristic. The STAIS-5, STAIT-5 each consists of 5 items. The scale items are scored on a 4-point Likert scale of 0 to 3 (0= Not at all, 1= Somewhat, 2= Moderately so, 3= Very much so). Higher scores indicate greater anxiety. The scale allow researchers to differentiate among anxious and healthy participants.
Measured: pre intervention
Secondary outcomes (2)
State Anxiety Inventory (STAIS-5)
The SAI items are scored on scored on a 4-point Likert scale of 0 to 3 (0= Not at all, 1= Somewhat, 2= Moderately so, 3= Very much so). Higher scores indicate greater anxiety
Measured: through study completion for each group, an average of 2 hours
Practice Success
blood pressure was measured to all students 3 times and all measurements were recorded. the instructors informed students about BPM and then paired them up, who then took each other's blood pressure using a sphygmomanometer and a stethoscope with headphones that enable both the participant and the instructors to listen to Korotkoff sounds. The instructors evaluated the participants'BPM performanceby listening to the Korotkoff sounds by one of the headphones and by monitoring the manometer
Measured: through study completion for each participant, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start3 Mar 2022
- Primary completion11 Mar 2022
- Study completion27 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turkan Ulker, TC Erciyes University
- Investigators
- TÜRKAN ÜLKER, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326685
- Sponsor's protocol ID
- 31
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visual Video With Korotkoff Sounds on Blood Pressure Measurement Skills and Anxiety Levels: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05326685
- Acronym / sponsor ID
- 31
- Conditions
- Anxiety
- Keywords
- Anxiety, Blood Pressure Measurement Skills, Korotkoff sounds, Nursing students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 27 Mar 2022 (actual)
- First posted
- 13 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.
Background: The aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels.
Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. Intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. Aural and visual video containing Korotkoff sounds were shown to the students before the practice.
Detailed description
Background: The aim of this study was to determine the effect of visual video with korotkoff sounds on nursing students' blood presssure measurement skills and anxiety levels.
Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. Intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. Aural and visual video containing Korotkoff sounds were shown to the students before the practice. The data of the research were collected with the State-Trait Anxiety Inventory short version (STAIS-5, STAIT-5) and the Student introduction form.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: video with korotkoff soundsvideo with korotkoff sounds |
| Control | No intervention | –standart practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Studying in the first year of the nursing department in the 2021-2022 academic year,
- Taking the "pulse and blood pressure measurement" course and laboratory practice
- Students who agree to participate in the study will be included.
Key exclusion criteria (3 listed)
- Previous manual blood pressure measurement experience,
- Those who do not participate in the theoretical part of the "pulse and blood pressure measurement" course,
- Students who do not attend the lesson on the day of the applications will not be included.
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 |
|---|---|---|
| video with korotkoff soundsThe State-Trait Anxiety Inventory short version (STAIS-5, STAIT-5) and the student introduction form were applied at the beginning of the study. Then Intervention participants were shown and listened visual video with korotkoff sounds before blood presssure measurement. Afterwards, blood pressure was measured to the students 3 times and 3 measurements were recorded. After the application about 2 hours later, the students State Anxiety Inventory short version (STAIS-5) form was filled again by students. | Other | Intervention |
Primary outcome
The State-Trait Anxiety Inventory (STAIS-5, STAIT-5)
Time frame: pre intervention
State-Trait Anxiety Inventory short version (STAIS-5, STAIT-5)[ Time Frame: pre-intervention ] The STAI consists of two parts; the State Anxiety Inventory (SAI) and the Trait Anxiety Inventory (TAI). The SAI measures anxiety about an event while the TAI measures anxiety level as a personal characteristic. The STAIS-5, STAIT-5 each consists of 5 items. The scale items are scored on a 4-point Likert scale of 0 to 3 (0= Not at all, 1= Somewhat, 2= Moderately so, 3= Very much so). Higher scores indicate greater anxiety. The scale allow researchers to differentiate among anxious and healthy participants.
2 secondary outcomes
State Anxiety Inventory (STAIS-5)
Time frame: through study completion for each group, an average of 2 hours
Practice Success
Time frame: through study completion for each participant, an average of 2 hours
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 13 Apr 2022.
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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.
TÜRKAN ÜLKER principal investigator
TC Erciyes 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 video with korotkoff sounds in people with Anxiety, run by TC Erciyes 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: finished, as of the sponsor's last update on 13 Apr 2022. 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?
The State-Trait Anxiety Inventory (STAIS-5, STAIT-5) (time frame: pre intervention). 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 13 Apr 2022.