StressstressNCT05087433
Perceived Stress and Anxiety Levels of Nurses
A study testing Progressive Relaxation Exercises in people with Stress and Anxiety, run by Ayşe Aydınlı at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of web-based progressive relaxation exercises applied to nurses working in a pandemic hospital on perceived stress and anxiety. In this randomized controlled clinical trial, nurses working in the pandemic hospital were randomly assigned to the control and intervention… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Progressive Relaxation Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 13 Mar 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those between the ages of 18-55
- Nurses working in the pandemic hospital
Who cannot join
- Nurses who did not agree to participate in the study
- Research Termination Criteria;
- Nurses who begin to receive support from a psychiatrist,
- Nurses who begin to use psychiatric medication,
- Nurses who are COVID positive,
- Moreover, the study was terminated with the nurses who wanted to leave the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University
Merkez, Isparta, 32200
About this study
Official title: The Effect of Web-based Progressive Relaxation Exercises on Perceived Stress and Anxiety on Nurses Working in a Pandemic Hospital: A Randomized Controlled Trial
This study was conducted to determine the effect of web-based progressive relaxation exercises applied to nurses working in a pandemic hospital on perceived stress and anxiety. In this randomized controlled clinical trial, nurses working in the pandemic hospital were randomly assigned to the control and intervention groups.
Read the detailed description
The coronavirus disease-2019 (COVID-19) epidemic increases the stress and anxiety level of nurses due to many factors. This study was conducted to determine the effect of web-based progressive relaxation exercises applied to nurses working in a pandemic hospital on perceived stress and anxiety. In this randomized controlled clinical trial, nurses working in the pandemic hospital were randomly assigned to the control and intervention groups. The Web-Based Relaxation Exercises Program was trained and implemented online for 4 weeks by a trainer for the intervention group.The Perceived Stress Scale (PSS) and the State-Trait Anxiety Inventory (STAI) were completed online by participants in both groups before and after the intervention
- Being tested
- Progressive Relaxation Exercises
- Keywords
- Anxiety, Pandemics, Nurse, Stress
- 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
The trainer performed the PRE exercise online with the nurses. The video recording of the progressive relaxation exercises was shared with the nurses participating in the study on WhatsApp groups. Nurses were asked to perform the PRE application in accordance with the commands in the video recordings. In addition, a guide in which the steps of applying progressive relaxation exercises for each muscle group were written was given to the nurses. It was stated that they should do the application regularly for 25-30 minutes in the morning every day at home for a month. The PRE application was reminded daily from the WhatsApp group for the nurses to apply regularly to the sessions and not to disrupt the sessions. Nurses shared the messages stating that they were doing the PRE application on a daily basis for four weeks on WhatsApp groups.
| Study group | Role | What they receive |
|---|---|---|
| İntervention Group | Experimental | Practicing Progressive Relaxation Exercises The training of the Zoom application progressive relaxation exercise for the nurses was done in two sessions for a total of 60 minutes. During the first interview, the definition, purpose, benefits, and application techniques of PRE were explained to the nurses in the intervention group. In the second session, the steps of progressive relaxation exercises were demonstrated by the trainer.
The trainer performed the PRE exercise online with the nurses. Nurses were asked to perform the PRE application in accordance with the commands in the video recordings. In addition, a guide in which the steps of applying progressive relaxation exercises for each muscle group were written was given to the nurses. It was stated that they should do the application regularly for 25-30 minutes in the morning every day at home for a month. Receives: Other: Progressive Relaxation Exercises |
| Control Group | No intervention | No intervention was applied to the control group during the study. However, after the research was completed, the video of the application of the progressive relaxation exercises to the control group was shared on the WhatsApp group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form:
Socio-demographic characteristics of nurses such as age, gender, educational status, working time in the profession, professional characteristics such as the unit they worked before and after the COVID-19 pandemic, working time and working style, how their family life was affected in the COVID-19 pandemic, and contains information on their greatest concern regarding the pandemic.
Measured: baseline
The Perceived Stress Scale
It is a five-point Likert-type scale and consists of 14 items. Participants rate each item on a scale ranging from "Never (0)" to "Very often (4)". Seven of the items with positive statements are scored in reverse. As the scores obtained from the scale increase, the perceived stress level of the person increases. PSS-14 scores range from 0 to 56, with 0-35 point range indicating normal stress level, 35-56 point range indicating that the individual is under stress.
Measured: four weeks
State-Trait Anxiety Inventory
The 4-point Likert-type State Anxiety Inventory, consisting of 20 items in total, measures a person's anxiety at a certain time. According to the severity of the feelings, thoughts or behaviors expressed by the items in the State-Trait Anxiety Inventory, it is required to choose one of the options "not at all," "a little," "a lot," and "totally". There are 10 (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20) reversed statements in the STAI. While scoring the scale, the reversed statements with a weight of 1 were converted to 4, and those with a weight of 4 were converted to 1. In direct statements, answers with a value of 4 indicate high anxiety. In reversed expressions, answers with a value of 1 indicate high anxiety, and a value of 4 indicates low anxiety. The last value obtained was accepted as the individual's anxiety score. It is reported that the level of anxiety is high for scores above 42 points.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2021
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşe Aydınlı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşe Aydınlı, Suleyman Demirel University
- Investigators
- Yurdagül Günaydın, Assist.Prof, Study director, Yozgat Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087433
- Sponsor's protocol ID
- Stress and Anxiety
- Acronym
- stress
- Status last verified
- Sep 2021
- First submitted
- 28 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hersch RK, Cook RF, Deitz DK, Kaplan S, Hughes D, Friesen MA, Vezina M. Reducing nurses' stress: A randomized controlled trial of a web-based stress management program for nurses. Appl Nurs Res. 2016 Nov;32:18-25. doi: 10.1016/j.apnr.2016.04.003. Epub 2016 Apr 9.
PubMed 27969025Kackin O, Ciydem E, Aci OS, Kutlu FY. Experiences and psychosocial problems of nurses caring for patients diagnosed with COVID-19 in Turkey: A qualitative study. Int J Soc Psychiatry. 2021 Mar;67(2):158-167. doi: 10.1177/0020764020942788. Epub 2020 Jul 16.
PubMed 32674644Labrague LJ, De Los Santos JAA. COVID-19 anxiety among front-line nurses: Predictive role of organisational support, personal resilience and social support. J Nurs Manag. 2020 Oct;28(7):1653-1661. doi: 10.1111/jonm.13121. Epub 2020 Aug 21.
PubMed 32770780Hacimusalar Y, Kahve AC, Yasar AB, Aydin MS. Anxiety and hopelessness levels in COVID-19 pandemic: A comparative study of healthcare professionals and other community sample in Turkey. J Psychiatr Res. 2020 Oct;129:181-188. doi: 10.1016/j.jpsychires.2020.07.024. Epub 2020 Jul 21.
PubMed 32758711
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-based Progressive Relaxation Exercises on Perceived Stress and Anxiety on Nurses Working in a Pandemic Hospital: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05087433
- Acronym / sponsor ID
- stress / Stress and Anxiety
- Keywords
- Anxiety, Pandemics, Nurse, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ayşe AydınlıUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 21 Oct 2021 (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.
This study was conducted to determine the effect of web-based progressive relaxation exercises applied to nurses working in a pandemic hospital on perceived stress and anxiety. In this randomized controlled clinical trial, nurses working in the pandemic hospital were randomly assigned to the control and intervention groups.
Detailed description
The coronavirus disease-2019 (COVID-19) epidemic increases the stress and anxiety level of nurses due to many factors. This study was conducted to determine the effect of web-based progressive relaxation exercises applied to nurses working in a pandemic hospital on perceived stress and anxiety. In this randomized controlled clinical trial, nurses working in the pandemic hospital were randomly assigned to the control and intervention groups. The Web-Based Relaxation Exercises Program was trained and implemented online for 4 weeks by a trainer for the intervention group.The Perceived Stress Scale (PSS) and the State-Trait Anxiety Inventory (STAI) were completed online by participants in both groups before and after the intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| İntervention Group | Experimental | Other: Progressive Relaxation ExercisesPracticing Progressive Relaxation Exercises The training of the Zoom application progressive relaxation exercise for the nurses was done in two sessions for a total of 60 minutes. During the first interview, the definition, purpose, benefits, and application techniques of PRE were explained to the nurses in the intervention group. In the second session, the steps of progressive relaxation exercises were demonstrated by the trainer. The trainer performed the PRE exercise online with the nurses. Nurses were asked to perform the PRE application in accordance with the commands in the video recordings. In addition, a guide in which the steps of applying progressive relaxation exercises for each muscle group were written was given to the nurses. It was stated that they should do the application regularly for 25-30 minutes in the morning every day at home for a month. |
| Control Group | No intervention | –No intervention was applied to the control group during the study. However, after the research was completed, the video of the application of the progressive relaxation exercises to the control group was shared on the WhatsApp group. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Those between the ages of 18-55
- Nurses working in the pandemic hospital
Key exclusion criteria (6 listed)
- Nurses who did not agree to participate in the study
- Research Termination Criteria;
- Nurses who begin to receive support from a psychiatrist,
- Nurses who begin to use psychiatric medication,
- Nurses who are COVID positive,
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 ExercisesThe trainer performed the PRE exercise online with the nurses. The video recording of the progressive relaxation exercises was shared with the nurses participating in the study on WhatsApp groups. Nurses were asked to perform the PRE application in accordance with the commands in the video recordings. In addition, a guide in which the steps of applying progressive relaxation exercises for each muscle group were written was given to the nurses. It was stated that they should do the application regularly for 25-30 minutes in the morning every day at home for a month. The PRE application was reminded daily from the WhatsApp group for the nurses to apply regularly to the sessions and not to disrupt the sessions. Nurses shared the messages stating that they were doing the PRE application on a daily basis for four weeks on WhatsApp groups. | Other | İntervention Group |
Primary outcome
Personal Information Form:
Time frame: baseline
Socio-demographic characteristics of nurses such as age, gender, educational status, working time in the profession, professional characteristics such as the unit they worked before and after the COVID-19 pandemic, working time and working style, how their family life was affected in the COVID-19 pandemic, and contains information on their greatest concern regarding the pandemic.
The Perceived Stress Scale
Time frame: four weeks
It is a five-point Likert-type scale and consists of 14 items. Participants rate each item on a scale ranging from "Never (0)" to "Very often (4)". Seven of the items with positive statements are scored in reverse. As the scores obtained from the scale increase, the perceived stress level of the person increases. PSS-14 scores range from 0 to 56, with 0-35 point range indicating normal stress level, 35-56 point range indicating that the individual is under stress.
State-Trait Anxiety Inventory
Time frame: four weeks
The 4-point Likert-type State Anxiety Inventory, consisting of 20 items in total, measures a person's anxiety at a certain time. According to the severity of the feelings, thoughts or behaviors expressed by the items in the State-Trait Anxiety Inventory, it is required to choose one of the options "not at all," "a little," "a lot," and "totally". There are 10 (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20) reversed statements in the STAI. While scoring the scale, the reversed statements with a weight of 1 were converted to 4, and those with a weight of 4 were converted to 1. In direct statements, answers with a value of 4 indicate high anxiety. In reversed expressions, answers with a value of 1 indicate high anxiety, and a value of 4 indicates low anxiety. The last value obtained was accepted as the individual's anxiety score. It is reported that the level of anxiety is high for scores above 42 points.
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 21 Oct 2021.
- Background: PubMed 27969025Hersch RK, Cook RF, Deitz DK, Kaplan S, Hughes D, Friesen MA, Vezina M. Reducing nurses' stress: A randomized controlled trial of a web-based stress management program for nurses. Appl Nurs Res. 2016 Nov;32:18-25. doi: 10.1016/j.apnr.2016.04.003. Epub 2016 Apr 9.
- Background: PubMed 32674644Kackin O, Ciydem E, Aci OS, Kutlu FY. Experiences and psychosocial problems of nurses caring for patients diagnosed with COVID-19 in Turkey: A qualitative study. Int J Soc Psychiatry. 2021 Mar;67(2):158-167. doi: 10.1177/0020764020942788. Epub 2020 Jul 16.
- Background: PubMed 32770780Labrague LJ, De Los Santos JAA. COVID-19 anxiety among front-line nurses: Predictive role of organisational support, personal resilience and social support. J Nurs Manag. 2020 Oct;28(7):1653-1661. doi: 10.1111/jonm.13121. Epub 2020 Aug 21.
- Background: PubMed 32758711Hacimusalar Y, Kahve AC, Yasar AB, Aydin MS. Anxiety and hopelessness levels in COVID-19 pandemic: A comparative study of healthcare professionals and other community sample in Turkey. J Psychiatr Res. 2020 Oct;129:181-188. doi: 10.1016/j.jpsychires.2020.07.024. Epub 2020 Jul 21.
- 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.
Yurdagül Günaydın, Assist.Prof study director
Yozgat Bozok 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 Relaxation Exercises in people with Stress and Anxiety, run by Ayşe Aydınlı 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 2 inclusion and 6 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 21 Oct 2021. 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?
Personal Information Form: (time frame: baseline). 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 NCT05087433, which also lists 4 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 21 Oct 2021.