NCT05697419

Brief Summary

The goal of this longitudinal prospective cohort study is to determine effectiveness of integrating NIH reset stress strategies of deep breathing, muscle relaxation and mindfulness in DPT students in order to help them reduce stress throughout their schooling. The main question\[s\] it aims to answer are:

  • Do performing the NIH reset stress strategies help DPT students manage their stress
  • Do DPT students find these strategies helpful Participants will be asked to fill out initial intake forms and participate in weekly sessions of five to ten minutes that will be either a deep breathing, mindfulness, or muscle relaxation activity led by faculty member. DPT students will then rate their stress level weekly on a numeric stress scale.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

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 5, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 5, 2023

Last Update Submit

January 13, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • PSS-10

    Stress questionnaire

    through study completion, an average of 1 year

  • DASS-21

    Depression, stress and Anxiety questionnaire

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Stress Numeric scale

    through study completion, an average of 1 year

Study Arms (1)

DPT students at YSU

OTHER
Behavioral: deep breathing, muscle relaxation, and mindfulness

Interventions

5-10-minute group sessions will be administered to DPT students teaching them the NIH recommended strategies of deep breathing, muscle relaxation or mindfulness.

DPT students at YSU

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • DPT student at Youngstown State University
  • \> 18 years old
  • Have the ability to follow instructions to perform deep breathing, muscle relaxation, and mindfulness strategies

You may not qualify if:

  • Not a DPT student at Youngstown State University
  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555-0001, United States

RECRUITING

Related Publications (9)

  • Gallego-Gomez JI, Balanza S, Leal-Llopis J, Garcia-Mendez JA, Oliva-Perez J, Domenech-Tortosa J, Gomez-Gallego M, Simonelli-Munoz AJ, Rivera-Caravaca JM. Effectiveness of music therapy and progressive muscle relaxation in reducing stress before exams and improving academic performance in Nursing students: A randomized trial. Nurse Educ Today. 2020 Jan;84:104217. doi: 10.1016/j.nedt.2019.104217. Epub 2019 Oct 18.

  • Lesage FX, Berjot S, Deschamps F. Clinical stress assessment using a visual analogue scale. Occup Med (Lond). 2012 Dec;62(8):600-5. doi: 10.1093/occmed/kqs140. Epub 2012 Sep 10.

  • Perciavalle V, Blandini M, Fecarotta P, Buscemi A, Di Corrado D, Bertolo L, Fichera F, Coco M. The role of deep breathing on stress. Neurol Sci. 2017 Mar;38(3):451-458. doi: 10.1007/s10072-016-2790-8. Epub 2016 Dec 19.

  • Gardi C, Fazia T, Stringa B, Giommi F. A short Mindfulness retreat can improve biological markers of stress and inflammation. Psychoneuroendocrinology. 2022 Jan;135:105579. doi: 10.1016/j.psyneuen.2021.105579. Epub 2021 Nov 6.

  • Pascoe MC, Thompson DR, Jenkins ZM, Ski CF. Mindfulness mediates the physiological markers of stress: Systematic review and meta-analysis. J Psychiatr Res. 2017 Dec;95:156-178. doi: 10.1016/j.jpsychires.2017.08.004. Epub 2017 Aug 23.

  • Pascoe MC, Thompson DR, Ski CF. Yoga, mindfulness-based stress reduction and stress-related physiological measures: A meta-analysis. Psychoneuroendocrinology. 2017 Dec;86:152-168. doi: 10.1016/j.psyneuen.2017.08.008. Epub 2017 Aug 30.

  • Zhang L, Qi H, Wang L, Wang F, Huang J, Li F, Zhang Z. Effects of the COVID-19 pandemic on acute stress disorder and career planning among healthcare students. Int J Ment Health Nurs. 2021 Aug;30(4):907-916. doi: 10.1111/inm.12839. Epub 2021 May 17.

  • Wang C, Wen W, Zhang H, Ni J, Jiang J, Cheng Y, Zhou M, Ye L, Feng Z, Ge Z, Luo H, Wang M, Zhang X, Liu W. Anxiety, depression, and stress prevalence among college students during the COVID-19 pandemic: A systematic review and meta-analysis. J Am Coll Health. 2023 Oct;71(7):2123-2130. doi: 10.1080/07448481.2021.1960849. Epub 2021 Sep 1.

  • Heckenberg RA, Eddy P, Kent S, Wright BJ. Do workplace-based mindfulness meditation programs improve physiological indices of stress? A systematic review and meta-analysis. J Psychosom Res. 2018 Nov;114:62-71. doi: 10.1016/j.jpsychores.2018.09.010. Epub 2018 Sep 22.

Related Links

MeSH Terms

Interventions

Muscle RelaxationMindfulness

Intervention Hierarchy (Ancestors)

Muscle ContractionMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Shannon Dudash, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Physical Therapy

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 25, 2023

Study Start

January 15, 2023

Primary Completion

January 15, 2024

Study Completion

January 15, 2024

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations