NCT07150741

Brief 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. 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.

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
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 25, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

Pain, Sleep Quality, Anxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 4 weeks after intervention completion

Secondary Outcomes (2)

  • Sleep Quality

    Baseline and 4 weeks after intervention completion

  • Anxiety Level

    Baseline and 4 weeks after intervention completion

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Ergonomic Training + Exercise Program
Intervention Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necibe

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety DisordersSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Necibe DAĞCAN ŞAHİN, PhD

    Kütahya Health Sciences University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Yiğit ŞAHİN, MSc

    Kütahya Dumlupınar University, Faculty of Sport Sciences

    STUDY DIRECTOR
  • Mustafa Said ERZEYBEK, Assoc. Prof.

    Kütahya Dumlupınar University, Faculty of Sport Sciences

    STUDY DIRECTOR

Central Study Contacts

Necibe DAĞCAN ŞAHİN, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and care providers are aware of group assignments. Data collection and outcome assessment will be conducted by a second researcher who is blinded to group allocation. The third researcher performing statistical analyses will also be blinded to group identity to minimize bias in outcome evaluation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Nursing

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 2, 2025

Study Start

September 15, 2025

Primary Completion

November 15, 2025

Study Completion

December 30, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Not applicable. Individual participant data will not be shared.

Locations