Perceived Stress and Anxiety Levels of Nurses (stress)

October 9, 2021 updated by: Ayşe Aydınlı

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Isparta
      • Merkez, Isparta, Turkey, 32200
        • Suleyman Demirel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those between the ages of 18-55
  • Nurses working in the pandemic hospital

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: İntervention Group

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.
Other: Progressive Relaxation Exercises
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.
No Intervention: Control Group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
four weeks
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.
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ayşe Aydınlı

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yurdagül Günaydın, Assist.Prof, Yozgat Bozok University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Stress and Anxiety

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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