AnxietyNCT05312749
The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students
A study testing progressive relaxation exercises in people with Anxiety and Stress, run by Ataturk University at 2 sites in Turkey (Türkiye).
Trial summary
Purpose: The study was conducted to examine the effect of web-based progressive muscle relaxation exercise on the perceived stress and anxiety level of nursing students who were in clinical practice for the first time. Method: This randomized controlled study was conducted at a state university in Turkey. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Stress, Nursing Students
- What is being tested?
- progressive relaxation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 27 Sep 2021to 25 Dec 2021
- 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 over 18 years old
- Studying in the 2021-2022 academic year
- Being in 2nd grade
- Not going into clinical practice before
Who cannot join
- Being under the age of 18
- Not studying in the 2021-2022 academic year
- Being in 1st, 3rd or 4th grade
- Prior clinical practice
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Fırat Üniversitesi
Elâzığ
Atatürk university nursing faculty
Erzurum, Center, 25240
About this study
Official title: The Effect of Web-Based Progressive Muscle Relaxation Exercise on the Perceived Stress and Anxiety Level of Nursing Students Found in Clinical Practice for the First Time: A Randomized Controlled Trial
Purpose: The study was conducted to examine the effect of web-based progressive muscle relaxation exercise on the perceived stress and anxiety level of nursing students who were in clinical practice for the first time.
Method: This randomized controlled study was conducted at a state university in Turkey. The sample of the study consisted of a total of 66 nursing students, 36 of whom were control and 30 interventions, who were educated in the 2021-2022 academic year, were in clinical practice for the first time and agreed to participate in the research. The intervention group was asked to perform a total of 36 sessions of progressive muscle relaxation exercise, 3 days a week for 12 weeks. Data; It was collected using the "Sociodemographic Characteristics Form", "State-Trait Anxiety Inventory (DSQ)" and "Perceived Stress Inventory (PSI)".
- Conditions
- Anxiety, Stress, Nursing Students, Relaxation Program
- Being tested
- progressive relaxation exercises
- 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 relaxation exercisesOther
Also called progressive muscle relaxation exercises
progressive relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| Experimental: | Experimental | Experimental: will do progressive relaxation exercises Receives: Other: progressive relaxation exercises |
| Control | No intervention | won't do progressive relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The State-Trait Anxiety Inventory
The State-Trait Anxiety Inventory was developed by Spielberger et al. (1970) (Spielger, Gorsuch, \& Lushene, 1970). The validity and reliability of the scale in Turkey was established by Öner and Le Compte (1983) (Öner \& Le Compte, 1983). The scale consists of two parts, the State Anxiety Inventory and the Trait Anxiety Inventory. The first 20 items assess situational anxiety, and the last 20 items assess trait anxiety. In this study, the "State Anxiety Inventory", which is the first 20 items, was used to evaluate situational anxiety. State Anxiety Scale; It was developed to determine how an individual feels at a certain moment and under certain conditions. The scale is 4-point Likert type. Scores from the scale range from 20 to 80. Higher scores indicate higher levels of anxiety.
Measured: 12 week
Perceived Stress Scale
The Perceived Stress Scale was developed by Cohen, Kamarck, and Mermelstein in 1983 to determine the level of stress that threatens human health (Cohen et al. 1983). Its Turkish validity and reliability were determined by Eskin et al. (2013) (Eskin et al., 2013). PSS-14 consists of 2 factors: "insufficient self-efficacy" and "stress" perception. The scale is a 5-point Likert type scale and consists of 14 items. As the scores obtained from the scale increase, the level of stress perceived by the person also increases. PSS scores range from 0 to 56, with 0-35 point range indicating normal stress level and 35-56 point range indicating that the individual is under stress.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start27 Sep 2021
- Primary completion25 Oct 2021
- Study completion25 Dec 2021
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 Ataturk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gülcan bahcecioğlu, Ataturk University
- Investigators
- Gülcan B.TURAN, PH, Study director, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312749
- Sponsor's protocol ID
- 2021/09-45
- Status last verified
- Apr 2022
- First submitted
- 16 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The article is intended to be shared after it is published.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based Progressive Muscle Relaxation Exercise on the Perceived Stress and Anxiety Level of Nursing Students Found in Clinical Practice for the First Time: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05312749
- Acronym / sponsor ID
- 2021/09-45
- Conditions
- Anxiety, Stress, Nursing Students, Relaxation Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 5 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.
Purpose: The study was conducted to examine the effect of web-based progressive muscle relaxation exercise on the perceived stress and anxiety level of nursing students who were in clinical practice for the first time.
Method: This randomized controlled study was conducted at a state university in Turkey. The sample of the study consisted of a total of 66 nursing students, 36 of whom were control and 30 interventions, who were educated in the 2021-2022 academic year, were in clinical practice for the first time and agreed to participate in the research. The intervention group was asked to perform a total of 36 sessions of progressive muscle relaxation exercise, 3 days a week for 12 weeks. Data; It was collected using the "Sociodemographic Characteristics Form", "State-Trait Anxiety Inventory (DSQ)" and "Perceived Stress Inventory (PSI)".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: | Experimental | Other: progressive relaxation exercisesExperimental: will do progressive relaxation exercises |
| Control | No intervention | –won't do progressive relaxation exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years old
- Studying in the 2021-2022 academic year
- Being in 2nd grade
- Not going into clinical practice before
Key exclusion criteria (4 listed)
- Being under the age of 18
- Not studying in the 2021-2022 academic year
- Being in 1st, 3rd or 4th grade
- Prior clinical 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 relaxation exercisesAlso: progressive muscle relaxation exercisesprogressive relaxation exercises | Other | Experimental: |
Primary outcome
The State-Trait Anxiety Inventory
Time frame: 12 week
The State-Trait Anxiety Inventory was developed by Spielberger et al. (1970) (Spielger, Gorsuch, \& Lushene, 1970). The validity and reliability of the scale in Turkey was established by Öner and Le Compte (1983) (Öner \& Le Compte, 1983). The scale consists of two parts, the State Anxiety Inventory and the Trait Anxiety Inventory. The first 20 items assess situational anxiety, and the last 20 items assess trait anxiety. In this study, the "State Anxiety Inventory", which is the first 20 items, was used to evaluate situational anxiety. State Anxiety Scale; It was developed to determine how an individual feels at a certain moment and under certain conditions. The scale is 4-point Likert type. Scores from the scale range from 20 to 80. Higher scores indicate higher levels of anxiety.
Perceived Stress Scale
Time frame: 12 week
The Perceived Stress Scale was developed by Cohen, Kamarck, and Mermelstein in 1983 to determine the level of stress that threatens human health (Cohen et al. 1983). Its Turkish validity and reliability were determined by Eskin et al. (2013) (Eskin et al., 2013). PSS-14 consists of 2 factors: "insufficient self-efficacy" and "stress" perception. The scale is a 5-point Likert type scale and consists of 14 items. As the scores obtained from the scale increase, the level of stress perceived by the person also increases. PSS scores range from 0 to 56, with 0-35 point range indicating normal stress level and 35-56 point range indicating that the individual is under stress.
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 11 Apr 2022.
- Carver, M. L., \& O'Malley, M. (2015). Progressive muscle relaxation to decrease anxiety in clinical simulations. Teaching and Learning in Nursing, 10(2), 57-62.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The article is intended to be shared after it is published.
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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.
Gülcan B.TURAN, PH study director
Firat University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive relaxation exercises in people with Anxiety and Stress, run by Ataturk University at 2 sites 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 4 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 11 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 2 sites 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 (time frame: 12 week). The study lists 2 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 11 Apr 2022.