NCT05087433

Brief 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 groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
Last Updated

October 21, 2021

Status Verified

September 1, 2021

Enrollment Period

Same day

First QC Date

September 28, 2021

Last Update Submit

October 9, 2021

Conditions

Keywords

AnxietyPandemicsNurseStress

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    four weeks

Study Arms (2)

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.

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.

Interventions

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.

İntervention Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Merkez, Isparta, 32200, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 27969025BACKGROUND
  • Kackin 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.

    PMID: 32674644BACKGROUND
  • Labrague 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.

    PMID: 32770780BACKGROUND
  • Hacimusalar 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.

    PMID: 32758711BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Yurdagül Günaydın, Assist.Prof

    Yozgat Bozok University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Asistant, RN, MsN, PhD

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 21, 2021

Study Start

February 1, 2021

Primary Completion

February 1, 2021

Study Completion

March 13, 2021

Last Updated

October 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations