AnxietyNCT04409938
Progressive Muscle Relaxation and Nature Sounds in Nursing Students
A study testing Progressive Muscle Relaxation and Nature 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 PMR and nature sounds on nursing students' BPM skills, and anxiety levels and vital signs. Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. 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?
- Progressive Muscle Relaxation and Nature Sounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2020to 28 Feb 2020
- 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
- being a first-year nursing student
- voluntary
- participating in the theoretical part of the "Pulse and Blood Pressure Measurement" course and in lab practice.
Who cannot join
- not participating in the theoretical part of the "Pulse and Blood Pressure Measurement" course and in lab practice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Muscle Relaxation and Nature Sounds on Blood Pressure Measurement Skills, Anxiety Levels, and Vital Signs in Nursing Students
Background: The aim of this study was to determine the effect of PMR and nature sounds on nursing students' BPM skills, and anxiety levels and vital signs.
Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR+NS participants practiced PMR accompanied by nature sounds.
Read the detailed description
Background: The aim of this study was to determine the effect of PMR and nature sounds on nursing students' BPM skills, and anxiety levels and vital signs.
Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises. PMR+NS participants practiced PMR accompanied by nature sounds.
- Conditions
- Anxiety
- Being tested
- Progressive Muscle Relaxation, Nature Sounds
- Keywords
- Skill training, Nursing students, Anxiety, Blood Pressure Measurement Skills
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationOther
PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises.
Nature SoundsOther
PMR+NS participants practiced PMR accompanied by nature sounds. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation | Experimental | PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. Receives: Other: Progressive Muscle Relaxation |
| Progressive Muscle Relaxation with Nature Sounds | Experimental | PMR+NS participants practiced PMR accompanied by nature sounds. Receives: Other: Progressive Muscle Relaxation; Other: Nature Sounds |
| Standard Practice | No intervention | The standard practice of the lab was made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The State-Trait Anxiety Inventory (STAI)
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 TAI and SAI each consists of 20 items. The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= never, 2= sometimes, 3= often, 4= always). The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= almost never, 2= sometimes, 3= often, 4= almost always). Ten SAI items (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20) and six TAI items (1, 6, 7, 13, 16, and 19) are reverse scored. Higher scores indicate greater anxiety.
Measured: pre-intervention
Secondary outcomes (2)
The State Anxiety Inventory (SAI)
The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= almost never, 2= sometimes, 3= often, 4= almost always). Ten SAI items (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20) and six TAI items (1, 6, 7, 13, 16, and 19) are reverse scored. Higher scores indicate greater anxiety
Measured: through study completion for each group, an average of 4 hour
The Blood Pressure Knowledge Test (BPKT)
BPKT is a multiple-choice test consisting of 20 items on definitions, physiology, affecting factors, classification, measurement sites, planning, application auscultation/ palpation measurement, and evaluation. A correct response is scored 1, and therefore, the total score ranges from 0 to 20.
Measured: through study completion for each group, an average of 4 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start3 Feb 2020
- Primary completion3 Feb 2020
- Study completion28 Feb 2020
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
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut, TC Erciyes University
- Investigators
- Sevda Korkut, PhD, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409938
- Sponsor's protocol ID
- 121
- Status last verified
- Aug 2020
- First submitted
- 21 May 2020
- Last updated
- 31 Aug 2020
- 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 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation and Nature Sounds on Blood Pressure Measurement Skills, Anxiety Levels, and Vital Signs in Nursing Students
- ClinicalTrials.gov ID
- NCT04409938
- Acronym / sponsor ID
- 121
- Conditions
- Anxiety
- Keywords
- Skill training, Nursing students, Anxiety, Blood Pressure Measurement Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 1 Jun 2020 (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 PMR and nature sounds on nursing students' BPM skills, and anxiety levels and vital signs.
Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR+NS participants practiced PMR accompanied by nature sounds.
Detailed description
Background: The aim of this study was to determine the effect of PMR and nature sounds on nursing students' BPM skills, and anxiety levels and vital signs.
Methods: This was a randomized controlled experimental study conducted at the nursing department of the faculty of health sciences of a university. PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises. PMR+NS participants practiced PMR accompanied by nature sounds.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation | Experimental | Other: Progressive Muscle RelaxationPMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. |
| Progressive Muscle Relaxation with Nature Sounds | Experimental | Other: Progressive Muscle Relaxation, Other: Nature SoundsPMR+NS participants practiced PMR accompanied by nature sounds. |
| Standard Practice | No intervention | –The standard practice of the lab was made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being a first-year nursing student
- voluntary
- participating in the theoretical part of the "Pulse and Blood Pressure Measurement" course and in lab practice.
Key exclusion criteria (1 listed)
- not participating in the theoretical part of the "Pulse and Blood Pressure Measurement" course and in lab practice.
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 |
|---|---|---|
| Progressive Muscle RelaxationPMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises. | Other | Progressive Muscle Relaxation, Progressive Muscle Relaxation with Nature Sounds |
| Nature SoundsPMR+NS participants practiced PMR accompanied by nature sounds. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises. | Other | Progressive Muscle Relaxation with Nature Sounds |
Primary outcome
The State-Trait Anxiety Inventory (STAI)
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 TAI and SAI each consists of 20 items. The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= never, 2= sometimes, 3= often, 4= always). The SAI items are scored on a 4-point Likert scale of 1 to 4 (1= almost never, 2= sometimes, 3= often, 4= almost always). Ten SAI items (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20) and six TAI items (1, 6, 7, 13, 16, and 19) are reverse scored. Higher scores indicate greater anxiety.
2 secondary outcomes
The State Anxiety Inventory (SAI)
Time frame: through study completion for each group, an average of 4 hour
The Blood Pressure Knowledge Test (BPKT)
Time frame: through study completion for each group, an average of 4 hour
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 31 Aug 2020.
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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.
Sevda Korkut, PhD 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 Progressive Muscle Relaxation and Nature 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 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 31 Aug 2020. 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 (STAI) (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 31 Aug 2020.