Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06279182 |
| Other study ID # |
IRB-FY2024-106 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2024 |
| Est. completion date |
April 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Idaho State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The healthcare profession of dental hygiene can be a highly stressful academic path and
occupation. Physical stressors can quickly lead to postural disturbances and musculoskeletal
disorders (MSDs) due to instrument grasping while under muscle tension, working with
vibrating instruments, and performing repetitive micromovements. Chronic, high stress levels
have the potential to lead to burnout, fatigue, and other health problems, which can impact a
student's ability to perform well in their clinical rotations and didactic studies and may
translate into their workforce experiences after graduation.
The purpose of this study is to determine whether a relationship exists between Barre
stretching and reported stress and pain levels among entry-level dental hygiene students.
This study will be a 6-week experimental randomized control trial (RCT) where participants
will be assigned to a 15-minute Barre stretching and breathing video two times a week for the
experimental group or control group. The continuous dependent variables in this study will be
the reported stress levels and reported pain levels of the entry-level dental hygiene
students. The independent variable will be the Barre stretching intervention. The
participants will include students at two universities enrolled in an entry-level dental
hygiene program as first-year students.
Baseline data collection for each participant will be obtained, and the study will be
analyzed using descriptive statistics, a paired t-test and independent t-test. The
statistical significance level will be set at P=0.05.
Description:
Due to the unknown relationship between Barre stretching and dental hygiene students'
reported stress and pain levels, the purpose of this research study is to determine whether
relationships exist between implementing a Barre stretching and breathing routine to reduce
this demographics' reported stress and pain levels. As technological advancements and patient
centered care continue to drive the dental profession, hygienists continue to face challenges
related to providing safe dental care for their patients and as practitioners while managing
stress. This methodology chapter discusses the study's design, research sample, setting, data
collection, statistical analysis, and limitations.
Overview of Study Research Questions. The following research questions guided the conduct of
this study.
1. What are the self-reported stress levels among first-year dental hygiene students
regarding job-related musculoskeletal training before and after participation in a
6-week regimented Barre stretching program?
2. What are the self-reported pain levels among first-year dental hygiene students
regarding job-related musculoskeletal training before and after participation in a
6-week regimented Barre stretching program?
Hypotheses. The two-hypothesis related to this study are:
H1: Entry-level dental hygiene students who participate in a 6-week Barre stretching
intervention will have statistically significant reduced levels of self-reported stress
compared to those entry-level dental hygiene students who do not participate in the Barre
intervention.
Ho: There is no significant difference in self-reported stress levels of entry-level dental
hygiene students after participating in a 6-week Barre stretching intervention as compared to
entry-level dental hygiene students who do not participate in the Barre intervention.
H1: Entry-level dental hygiene students who participate in a 6-week Barre stretching
intervention will have statistically significant reduced levels of self-reported stress
compared to those entry-level dental hygiene students who do not participate in the Barre
intervention.
Ho: There is no significant difference in self-reported pain of entry-level dental hygiene
students after participating in a 6-week Barre stretching intervention as compared to
entry-level dental hygiene students who do not participate in the Barre intervention.
Variables The continuous dependent variables in this study will be the self-reported stress
and pain levels of the entry-level dental hygiene students. The categorical dependent
variables will be the Perceived Stress Scale (PSS-10) and the Numerical Rating Pain Scale
(NRPS-11). The independent variable will be the Barre stretching intervention.
Research Design This study will be an experimental randomized control trial (RCT). A
randomized control trial is a prospective study where data is collected over time and
participants are tracked to measure the effectiveness of a new treatment or intervention. A
RCT was selected for this study to investigate the research questions to evaluate differences
between the experimental and control groups, while reducing bias and establishing a
cause-effect relationship between the intervention and the outcome. This experimental RCT
will have a two-group pre-and post-test design. Baseline data collection for each participant
will be obtained, and the study will be analyzed using descriptive statistics, a paired
t-test and independent t-test. The statistical significance level will be set at P=0.05. The
CONSORT checklist when reporting a pilot or feasibility study will be used as a guide for
this study.
Research Context The participants will include Eastern Washington University and Idaho State
University students enrolled in an entry-level dental hygiene program as first-year students.
Two universities will be selected to increase the sample size of this study and provide a
better representation of the population. These two institutions will provide good prospects
for a sample study of participants due to a highly competitive application process and
baccalaureate degree completions.
Research Participants Sample Description. A convenience sample of students from Eastern
Washington University and 30 students from Idaho State University's Department of Dental
Hygiene baccalaureate program's first-year entry-level dental hygiene students will be
invited to participate in the study. A convenience sample will be utilized to represent
entry-level dental hygiene students who are new to the profession of dental hygiene and
likely unaware of ergonomics and work-related musculoskeletal disorder risks, and potentially
in a stressful time of their robust curriculum. Although convenience samples are
non-probability sampling methods, they are widely used in clinical educational research and
the most applicable for the purpose of this study based on subject availability and
accessibility of entry-level dental hygiene students.
The participants for this research study were recruited after email contact was established
through their program directors and lead clinical instructors at each university, ISU and
EWU. An introduction of the study outlining its purpose and student involvement was
presented, including an informed consent, followed by a health history pre-screening form, if
qualified. The participating entry-level dental hygiene student's pre-screening medical
histories will be reviewed to identify pre-existing conditions that might disqualify students
from participating in the study.
Inclusion criteria. Participants of this convenience sample will be entry-level dental
hygiene students (aged 18 or over) without any significant health limitations that will
prevent the student from participating in Barre stretching movements.
Exclusion criteria. Entry-level dental hygiene student individuals who are under the age of
18 and with significant health limitations that will prevent them from participating in Barre
stretching movements, will not be included in the study. Significant health conditions will
include unstable joints or recent joint replacements and/or history of back/spinal injuries.
Significant health conditions deeming participants exempt from participation will include
unstable joints or recent joint replacements, and/or history of back/spinal injuries.
Human Subjects Protection. The proposal will be submitted to the Human Subjects Committee at
Idaho State University for approval. Once approved by the Human Subjects Committee at Idaho
State University, the study will be registered for a clinical trial number through
clinicaltrials.gov. Additionally, after approval is given, a pre-intervention medical history
will be completed by participants to identify if participants will meet the study inclusion
criteria. Eligible participants' consent will be obtained via written consent form.
Data Collection. Qualifying participants will be asked to complete the Perceived Stress Scale
(PSS-10) to establish self-reported stress levels and the Numerical Rating Pain Scale/Visual
Analog Scale (NRPS-11/VAS) to establish self-reported pain levels prior to participating in
either the control group or the intervention group. Participants will be divided into an even
distribution of participants in either the intervention or control group. The post-test will
be administered to the participants through published content through their universities
individual learning management systems, Moodle and Canvas, respectively.
Instruments. The instrument to measure pain levels will be the Numerical Rating Pain Scale
(NRPS-11) & Visual Analog Scale (VAS), a self-reported pain survey, and the Perceived Stress
Scale (PSS-10), a self-reported stress survey. Written permission was stated and given for
use of the NRPS-11/VAS and PSS-10 scales for educational and clinical research. Self-reported
PSS-10 and NRPS-11/VAS questionnaires will be provided to the students at the beginning of
their winter quarter term, through their learning management systems to complete
electronically. Eastern Washington University utilizes the platform Canvas, and Idaho State
University utilizes the platform, Moodle. The 6-week Barre stretching intervention
instructional video will be published for students to access their individual learning
management systems and will be completed two times a week (Monday and Thursday).
Procedure and Protocols. The participants will be assigned into a control group or
experimental group through a computer-generated random assignment generator, Research
Randomizer. The experimental group will receive the Barre stretching intervention. Since the
Barre stretching video session will be online, the students will be instructed to complete it
in a quiet, comfortable setting. The trial's intention is to create a relaxed session
environment which disrupted the student's learning environment as little as possible, without
affecting the outcome of the study. The Barre stretching intervention will consist of a
15-minute recorded video session with static and isometric movements focused on the hands,
wrists, shoulders, and neck combined with breathing exercises throughout each movement. A
15-minute Barre stretching video will be selected for this study because static and isometric
stretching should be held for 10-15 seconds per movement and repeated 2-3 times for
increasing blood flow and circulation which can improve heart rate variability (HRV),
increase muscle suppleness in preparation for muscle activation through patient care, and
reduce stress levels through regulation of the rate, depth, and pattern of breathing. The
duration of 15-minutes provided the participants with adequate time to complete each
stretching movement for a total of 45 seconds with 15 seconds rest between movements. There
will be fifteen targeted stretching movements focused on the hands, wrists, shoulders, and
neck region.
Reliability and Validity. The PSS-10 perceived stress scale was selected for this study due
to demonstrated adequate internal consistency (Cronbach's Alpha = .87), hypothesis testing
[HEALTH (r = -.37); MENT (r = -.32); PHYS (= -.24)], and test-retest reliability (.86). The
PSS-10 scale is a stress assessment instrument that consists of ten Likert-scale questions
intended to measure current life situations represented as unpredictable and/or
uncontrollable. The NPRS-11/VAS is a pain assessment instrument that consists of an 11-point
Likert scale used to measure self-reported pain among adult populations. The participant will
select a whole number (0-10) that best reflects the intensity of their reported pain, with 0
= no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, and 10 = extreme
pain/worst pain possible. The NPRS-11/VAS was selected for this study due to demonstrated
high test-retest reliability (r = 0.82) and correlation validity of the NPRS and VAS (r =
0.941).
Limitations. There may be limitations to this study, which include a smaller sample size
(n=60), which limits the capacity of the statistical analysis. Another limitation is the
selection of a convenience sample of entry-level dental hygiene students.
This RCT study collected two forms of data amongst entry-level dental hygiene students:
self-reported stress levels (PSS-10) and self-reported pain levels (NPRS-11/VAS). The
findings of this study addressed the research objective listed by the National Dental Hygiene
Research Agenda related to occupational health, focused on "career satisfaction and longevity
research assessing the dissemination and translation into practice methods that reduce the
harmful effects of occupational stressors on practitioners." This RCT will address Healthy
People 2030 objectives centered around improving public health issues using science-based
objectives to increase the proportion of adults who engage in physical activity for
substantial health benefits (PA-02, PA-03, PA-04, and PA-05). The results and discussion
manuscript will be reported in the form of a manuscript to be submitted for publication in
the International Journal of Dental Hygiene. The remaining sections of the thesis reflect the
manuscript specifications outlined in the author guidelines located at
https:www.adha.org/journal-of-dental-hygiene/.
