NCT05753527

Brief Summary

The simulation-based learning method causes a sense of anxiety in students. Studies have shown that progressive relaxation exercises have a positive effect on anxiety. This study, will be tried to determine the effect of the progressive relaxation exercises applied to the students before the simulation training on anxiety, student satisfaction, and stress. This study is an intervention study with a pretest-posttest control group. Before the study, Personal Information Form, State Anxiety Scale, Student Satisfaction and Self-Confidence in Learning Scale, Perceived Stress Scale for Nursing Students, and Students' Vital Findings Evaluation Form will be applied. After applying progressive relaxation exercises to the intervention group, they will be taken to the simulation laboratory. The control group will be taken to the simulation laboratory without any intervention. After the simulation application, the scales will be re-applied and the vital signs of the students will be measured again.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

January 23, 2023

Last Update Submit

March 2, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • State Anxiety Scale

    It is an inventory developed to measure state and trait anxiety. Inventory is used to determine how an individual feels at a particular moment and in a situation. The scale is a very sensitive measurement tool for evaluating abruptly changing emotional reactions. The lowest total score that can be obtained from the State Anxiety Scale is 20, and the highest total score is 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety. The final result is the individual's state anxiety score. The scale is a very sensitive measurement tool for evaluating abruptly changing emotional reactions.

    It will be applied to the students just before simulation and after completing the training on the same day (each session is 60 minutes). Change from baseline State Anxiety Scale scores at the end of 60 minutes.

  • Student Satisfaction and Self-Confidence in Learning Scale

    This scale, which is widely used to evaluate students' attitudes and beliefs about simulation, was published by the National League for Nurses. The highest total score that can be obtained from the scale is 65, and the lowest is 13. The high score that can be obtained from the total of the scale indicates high satisfaction and self-confidence.

    It will be applied to the students just before simulation and after completing the training on the same day (each session is 60 minutes). Change from baseline Student Satisfaction and Self-Confidence in Learning Scale scores at the end of 60 minutes.

  • Perceived Stress Scale for Nursing Students

    The scale aims to measure the level of stress perceived by the students. The scale has six sub-dimensions (Stress caused by lack of professional knowledge and skills, Stress experienced while caring for the patient, Stress caused by homework and workload, Stress caused by instructors and nurses, Stress caused by the environment, Stress caused by peers and daily life). The total score of the scale ranges from 0 to 116. A high score indicates a high level of stress.

    It will be applied to the students just before simulation and after completing the training on the same day (each session is 60 minutes). Change from baseline Perceived Stress scores at the end of 60 minutes.

  • Change from Baseline Pulse Rates at 60 minutes

    The pulse rates of all students will be measured and recorded just before simulation training and after completing the training on the same day (each session is 60 minutes)

    The pulse will be measured just before simulation training and after completing the training on the same day (each session is 60 minutes). Change from baseline pulse rates at the end of 60 minutes.

  • Change from Baseline Blood Pressure at 60 minutes

    The blood pressure of all students will be measured and recorded just before simulation training and after completing the training on the same day (each session is 60 minutes)

    The blood pressure will be measured just before simulation training and after completing the training on the same day (each session is 60 minutes). Change from baseline blood pressure values at the end of 60 minutes.

  • Change from Baseline Respiratory Rates at 60 minutes

    The respiratory rates of all students will be measured and recorded just before simulation training and after completing the training on the same day (each session is 60 minutes)

    The respiratory rate will be measured just before simulation training and after completing the training on the same day (each session is 60 minutes). Change from baseline respiratory rate values at the end of 60 minutes.

Study Arms (2)

Progressive relaxation exercise group

EXPERIMENTAL

The students in the intervention group will be given progressive relaxation exercises before the simulation application. Before and after the simulation, vital signs will be taken and scales will be applied.

Behavioral: Progressive Relaxation Exercises

The group not applied progressive relaxation exercise

NO INTERVENTION

The students in the control group will be taken into the simulation application without applying relaxation exercises. Before and after the simulation application, vital signs will be taken and scales will be applied.

Interventions

Deep abdominal breathing will be done three times and the breath will be given slowly. The fists will be clenched, keep the fists clenched in this way for 7-10 seconds, and then release them for 15-20 seconds. By opening the arms to the side and locking the elbows, the triceps muscle will be stretched and relaxed. The forehead muscles by raising the eyebrows The eyes will be closed and relaxed. The mouth will be opened and closed. The head will be stretched back and relaxed. The shoulders will be lifted and relaxed. Both hips will be tightened and relaxed by bringing them closer together. The thigh muscles will be tightened and relaxed.

Progressive relaxation exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer students aged 18 and over will be included in the study.

You may not qualify if:

  • Using any medication that affects the heart rate,
  • Having any psychiatric disease such as anxiety disorder,
  • Students who do not accept to participate in the research will not be included in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Didem Kaya

Kocasi̇nan, Kayseri, Turkey (Türkiye)

Location

Related Publications (17)

  • Abraham, C. M., & de Cordova, P. B. (2019). Simulation Activity and Inter-Professional Education in Pre-Licensure Nursing Programs in New Jersey: A 3 Year Trend Analysis. Teaching and Learning in Nursing, 14(3), 166-172.

    BACKGROUND
  • Jeffries, P. (2007). Simulation in Nursing Education: From Conceptualization to Evaluation. New York, NY: National League for Nursing.

    BACKGROUND
  • Mıdık, Ö., Kartal, M. (2010). Simülasyona dayalı tıp eğitimi. Marmara Medical Journal. 23(3): 389-99.

    BACKGROUND
  • Groom, A.J., Henderson, D., Sittner, J.B. (2013). National league for nursing jeffries simulation framework state of the science project:simulation design characteristics., Clinical Simulation in Nursing, 10(7): 337-344.

    BACKGROUND
  • Lewis R, Strachan A, Smith MM. Is high fidelity simulation the most effective method for the development of non-technical skills in nursing? A review of the current evidence. Open Nurs J. 2012;6:82-9. doi: 10.2174/1874434601206010082. Epub 2012 Jul 27.

    PMID: 22893783BACKGROUND
  • Gosselin, K. P., Holland, B., Mulcahy, A., Williamson, S., & Widacki, A. (2016). Music for anxiety reduction and performance enhancement in nursing simulation. Clinical Simulation in Nursing, 12(1), 16-23.

    BACKGROUND
  • Nielsen, B., & Harder, N. (2013). Causes of student anxiety during simulation: What the literature says. Clinical Simulation in Nursing, 9(11), e507-e512.

    BACKGROUND
  • Yockey, J., & Henry, M. (2019). Simulation Anxiety across the Curriculum. Clinical Simulation in Nursing, 29, 29-37.

    BACKGROUND
  • Beischel KP. Variables affecting learning in a simulation experience: a mixed methods study. West J Nurs Res. 2013 Feb;35(2):226-47. doi: 10.1177/0193945911408444. Epub 2011 May 18.

    PMID: 21593285BACKGROUND
  • Horsley, T. L., & Wambach, K. (2015). Effect of nursing faculty presence on students' anxiety, self-confidence, and clinical performance during a clinical simulation experience. Clinical Simulation in Nursing, 11, 4-10.

    BACKGROUND
  • Lai HL, Chen PW, Chen CJ, Chang HK, Peng TC, Chang FM. Randomized crossover trial studying the effect of music on examination anxiety. Nurse Educ Today. 2008 Nov;28(8):909-16. doi: 10.1016/j.nedt.2008.05.011. Epub 2008 Jul 1.

    PMID: 18597899BACKGROUND
  • Horsley, T. L., & Wambach, K. (2015). Effect of nursing faculty presence on students' anxiety, self-confidence, and clinical performance during a clinical simulation experience. Clinical Simulation in Nursing, 11(1), 4-10.

    BACKGROUND
  • Moscaritolo LM. Interventional strategies to decrease nursing student anxiety in the clinical learning environment. J Nurs Educ. 2009 Jan;48(1):17-23. doi: 10.3928/01484834-20090101-08.

    PMID: 19227751BACKGROUND
  • Martha L. Carver BSN, Maureen O'Malley PhD, Progressive muscle relaxation to decrease anxiety in clinical simulations, Teaching and Learning in Nursing, 2015, 10:57-62.

    BACKGROUND
  • Torabizadeh C, Bostani S, Yektatalab S. Comparison between the effects of muscle relaxation and support groups on the anxiety of nursing students: A randomized controlled trial. Complement Ther Clin Pract. 2016 Nov;25:106-113. doi: 10.1016/j.ctcp.2016.09.001. Epub 2016 Sep 7.

    PMID: 27863599BACKGROUND
  • Dehghan-Nayeri N, Adib-Hajbaghery M. Effects of progressive relaxation on anxiety and quality of life in female students: a non-randomized controlled trial. Complement Ther Med. 2011 Aug;19(4):194-200. doi: 10.1016/j.ctim.2011.06.002. Epub 2011 Jul 12.

    PMID: 21827933BACKGROUND
  • Spielberger CD, Gorsuch RL, Lushene RE, 1970. STAI. Manual for the State-Trait Anxiety Inventory (Self Evaluation Questionnaire). Palo Alto California: Consulting Psychologist, 22, 1-24.

    BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Central Study Contacts

DİDEM KAYA, Assist.Prof.Dr.

CONTACT

Ayşe Arıkan Dönmez, Assist.Prof.Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

January 23, 2023

First Posted

March 3, 2023

Study Start

October 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Study results will be shared with other researchers.

Locations