PainEASENCT07150741
Exercise-Assisted Ergonomic Training for Pain, Sleep, and Anxiety in Nursing Students: RCT
A study testing Exercise-Assisted Ergonomic Training in people with Pain and Sleep, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of exercise-assisted ergonomic training on pain, sleep quality, and anxiety levels among nursing students. The study population consists of students enrolled in the Nursing Department of Kütahya Health Sciences University. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Sleep, Anxiety State
- What is being tested?
- Exercise-Assisted Ergonomic Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a student in the Nursing Department of Kütahya Health Sciences University.
- Willingness to participate in the study voluntarily.
- No chronic diseases preventing exercise (e.g., COPD, heart failure).
- No hearing impairments.
- No psychiatric diagnosis (e.g., major depression, anxiety disorders) and not using related medications.
- Ability to use a smartphone (iOS or Android) and have internet access.
- No neurological, systemic, or psychiatric disorders.
Who cannot join
- Students unwilling to participate in the study.
- Developing any health problem during the intervention period.
- Unable to continue participation for any reason.
- Voluntarily withdrawing from the study.
- Pain level above 5 on the Numeric Pain Rating Scale at baseline; such participants will be referred to a physiotherapist.
- Any adverse events during exercise sessions (e.g., sudden pain, dizziness, fatigue, blood pressure changes) will result in immediate cessation of the exercise, monitoring of the participant, and referral to the nearest healthcare facility if necessary. Emergency first aid will be provided if needed, and the responsible researcher will contact the relevant health services immediately.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Exercise-Assisted Ergonomic Training on Pain, Sleep Quality, and Anxiety Levels in Nursing Students: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of exercise-assisted ergonomic training on pain, sleep quality, and anxiety levels among nursing students. The study population consists of students enrolled in the Nursing Department of Kütahya Health Sciences University. Sixty participants will be recruited according to inclusion criteria and randomly assigned into intervention and control groups.
The intervention group will receive a structured ergonomic training program combined with exercise sessions, including theoretical lectures and practical exercise videos delivered twice a week for four weeks. The control group will continue with their standard nursing curriculum without additional ergonomic or exercise support. Data will be collected using the Numeric Pain Rating Scale, Pittsburgh Sleep Quality Index, and State Anxiety Inventory before and after the intervention.
The study is expected to provide evidence on the effectiveness of ergonomic and exercise-based strategies in reducing pain, improving sleep quality, and lowering anxiety among nursing students, supporting the integration of such programs into nursing education.
Read the detailed description
Objective:
This study aims to evaluate the effect of exercise-assisted ergonomic training on pain, sleep quality, and anxiety levels among nursing students.
Study Design:
This is a randomized controlled experimental trial. Sixty nursing students who meet inclusion criteria and volunteer to participate will be randomly assigned to either the intervention group (Group A) or control group (Group B), with 30 participants per group. Randomization will be performed using computer-assisted software (www.randomization.com
).
Intervention:
Theoretical Training: The intervention group will receive two theoretical training sessions covering ergonomics, posture analysis, body mechanics, ergonomic risks in nursing, and recommended exercises.
Practical Exercise Sessions: Over four weeks, participants will complete eight exercise sessions (2 per week, 30-40 minutes each) via videos demonstrating warm-up, stretching, strengthening, balance, and posture exercises. The sessions will be supervised by an exercise expert to ensure safety and proper technique.
The control group will continue with the standard nursing curriculum without additional ergonomic or exercise support.
Data Collection:
Data will be collected before and after the intervention using:
Demographic Characteristics Form
Numeric Pain Rating Scale
Pittsburgh Sleep Quality Index
State Anxiety Inventory
Blinding and Bias Prevention:
Participants will be blinded to the group assignments. Data collection will be conducted by a second researcher unaware of the group allocations, and a third researcher will analyze the data while blinded to group identity. CONSORT guidelines will be followed in reporting the results.
Expected Outcomes:
The study is expected to provide evidence on the effectiveness of exercise-assisted ergonomic training in reducing pain, improving sleep quality, and lowering anxiety levels among nursing students, supporting the integration of ergonomic and exercise-based strategies in nursing education.
- Conditions
- Pain, Sleep, Anxiety State
- Being tested
- Exercise-Assisted Ergonomic Training
- Keywords
- Pain, Sleep Quality, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-Assisted Ergonomic TrainingBehavioural
Also called Ergonomic Training + Exercise Program
The program includes structured ergonomic and exercise activities designed to improve posture, reduce musculoskeletal pain, enhance sleep quality, and decrease anxiety levels among nursing students. Theoretical lectures cover ergonomics principles, postural assessment, body mechanics, and ergonomic risks in nursing. Practical sessions are delivered via video twice a week for 4 weeks, each lasting 30-40 minutes, including warm-up, stretching, strengthening, balance, and posture exercises. The intervention is supervised by an exercise specialist to ensure safety and proper technique.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive exercise-assisted ergonomic training over 4 weeks. The program includes two theoretical training sessions covering ergonomics, posture analysis, body mechanics, ergonomic risks in nursing, and recommended exercises. In addition, participants will complete eight practical exercise sessions via videos (2 per week, 30-40 minutes each) including warm-up, stretching, strengthening, balance, and posture exercises. The intervention is supervised by an exercise expert to ensure proper technique and safety. Receives: Behavioral: Exercise-Assisted Ergonomic Training |
| Control group | No intervention | Participants will continue with their standard nursing curriculum and will not receive additional ergonomic or exercise training during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS) before and after the 4-week exercise-assisted ergonomic training program.
Measured: Baseline and 4 weeks after intervention completion
Secondary outcomes (2)
Sleep Quality
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and after 4 weeks of intervention.
Measured: Baseline and 4 weeks after intervention completion
Anxiety Level
State anxiety will be measured using the State Anxiety Inventory (SAI) at baseline and after 4 weeks of intervention.
Measured: Baseline and 4 weeks after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into two parallel groups. The intervention group will receive exercise-assisted ergonomic training, including theoretical lectures and practical exercise sessions, while the control group will continue with the standard nursing curriculum without additional ergonomic or exercise support. Each participant will remain in their assigned group throughout the study, and outcomes will be compared between the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necibe Dağcan, Kutahya Health Sciences University
- Investigators
- Necibe DAĞCAN ŞAHİN, PhD, Principal investigator, Kütahya Health Sciences University, Faculty of Health SciencesYiğit ŞAHİN, MSc, Study director, Kütahya Dumlupınar University, Faculty of Sport SciencesMustafa Said ERZEYBEK, Assoc. Prof., Study director, Kütahya Dumlupınar University, Faculty of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150741
- Sponsor's protocol ID
- KutahyaHSU-NECİBE-DAĞCAN-0007
- Acronym
- EASE
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable. Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise-Assisted Ergonomic Training on Pain, Sleep Quality, and Anxiety Levels in Nursing Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07150741
- Acronym / sponsor ID
- EASE / KutahyaHSU-NECİBE-DAĞCAN-0007
- Conditions
- Pain, Sleep, Anxiety State
- Keywords
- Pain, Sleep Quality, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to evaluate the effect of exercise-assisted ergonomic training on pain, sleep quality, and anxiety levels among nursing students. The study population consists of students enrolled in the Nursing Department of Kütahya Health Sciences University. Sixty participants will be recruited according to inclusion criteria and randomly assigned into intervention and control groups.
The intervention group will receive a structured ergonomic training program combined with exercise sessions, including theoretical lectures and practical exercise videos delivered twice a week for four weeks. The control group will continue with their standard nursing curriculum without additional ergonomic or exercise support. Data will be collected using the Numeric Pain Rating Scale, Pittsburgh Sleep Quality Index, and State Anxiety Inventory before and after the intervention.
The study is expected to provide evidence on the effectiveness of ergonomic and exercise-based strategies in reducing pain, improving sleep quality, and lowering anxiety among nursing students, supporting the integration of such programs into nursing education.
Detailed description
Objective:
This study aims to evaluate the effect of exercise-assisted ergonomic training on pain, sleep quality, and anxiety levels among nursing students.
Study Design:
This is a randomized controlled experimental trial. Sixty nursing students who meet inclusion criteria and volunteer to participate will be randomly assigned to either the intervention group (Group A) or control group (Group B), with 30 participants per group. Randomization will be performed using computer-assisted software (www.randomization.com
).
Intervention:
Theoretical Training: The intervention group will receive two theoretical training sessions covering ergonomics, posture analysis, body mechanics, ergonomic risks in nursing, and recommended exercises.
Practical Exercise Sessions: Over four weeks, participants will complete eight exercise sessions (2 per week, 30-40 minutes each) via videos demonstrating warm-up, stretching, strengthening, balance, and posture exercises. The sessions will be supervised by an exercise expert to ensure safety and proper technique.
The control group will continue with the standard nursing curriculum without additional ergonomic or exercise support.
Data Collection:
Data will be collected before and after the intervention using:
Demographic Characteristics Form
Numeric Pain Rating Scale
Pittsburgh Sleep Quality Index
State Anxiety Inventory
Blinding and Bias Prevention:
Participants will be blinded to the group assignments. Data collection will be conducted by a second researcher unaware of the group allocations, and a third researcher will analyze the data while blinded to group identity. CONSORT guidelines will be followed in reporting the results.
Expected Outcomes:
The study is expected to provide evidence on the effectiveness of exercise-assisted ergonomic training in reducing pain, improving sleep quality, and lowering anxiety levels among nursing students, supporting the integration of ergonomic and exercise-based strategies in nursing education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups. The intervention group will receive exercise-assisted ergonomic training, including theoretical lectures and practical exercise sessions, while the control group will continue with the standard nursing curriculum without additional ergonomic or exercise support. Each participant will remain in their assigned group throughout the study, and outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Exercise-Assisted Ergonomic TrainingParticipants will receive exercise-assisted ergonomic training over 4 weeks. The program includes two theoretical training sessions covering ergonomics, posture analysis, body mechanics, ergonomic risks in nursing, and recommended exercises. In addition, participants will complete eight practical exercise sessions via videos (2 per week, 30-40 minutes each) including warm-up, stretching, strengthening, balance, and posture exercises. The intervention is supervised by an exercise expert to ensure proper technique and safety. |
| Control group | No intervention | –Participants will continue with their standard nursing curriculum and will not receive additional ergonomic or exercise training during the study period. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being a student in the Nursing Department of Kütahya Health Sciences University.
- Willingness to participate in the study voluntarily.
- No chronic diseases preventing exercise (e.g., COPD, heart failure).
- No hearing impairments.
- No psychiatric diagnosis (e.g., major depression, anxiety disorders) and not using related medications.
Key exclusion criteria (6 listed)
- Students unwilling to participate in the study.
- Developing any health problem during the intervention period.
- Unable to continue participation for any reason.
- Voluntarily withdrawing from the study.
- Pain level above 5 on the Numeric Pain Rating Scale at baseline; such participants will be referred to a physiotherapist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise-Assisted Ergonomic TrainingAlso: Ergonomic Training + Exercise ProgramThe program includes structured ergonomic and exercise activities designed to improve posture, reduce musculoskeletal pain, enhance sleep quality, and decrease anxiety levels among nursing students. Theoretical lectures cover ergonomics principles, postural assessment, body mechanics, and ergonomic risks in nursing. Practical sessions are delivered via video twice a week for 4 weeks, each lasting 30-40 minutes, including warm-up, stretching, strengthening, balance, and posture exercises. The intervention is supervised by an exercise specialist to ensure safety and proper technique. | Behavioural | Intervention Group |
Primary outcome
Pain Level
Time frame: Baseline and 4 weeks after intervention completion
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS) before and after the 4-week exercise-assisted ergonomic training program.
2 secondary outcomes
Sleep Quality
Time frame: Baseline and 4 weeks after intervention completion
Anxiety Level
Time frame: Baseline and 4 weeks after intervention completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No. Not applicable. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Necibe DAĞCAN ŞAHİN, PhD principal investigator
Kütahya Health Sciences University, Faculty of Health Sciences
Yiğit ŞAHİN, MSc study director
Kütahya Dumlupınar University, Faculty of Sport Sciences
Mustafa Said ERZEYBEK, Assoc. Prof. study director
Kütahya Dumlupınar University, Faculty of Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise-Assisted Ergonomic Training in people with Pain and Sleep, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Necibe DAĞCAN ŞAHİN, PhD (0553 701 19 35, necibe.dagcan@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: Baseline and 4 weeks after intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.