NCT07326527

Brief Summary

This randomized controlled study investigates the effects of an eight-week tele-based postural awareness and pranayama-based breathing program on work-related ergonomic risk and cervical somatosensory function in flute students. A total of 30 undergraduate flute students were randomly allocated to either an intervention group or a control group. Participants in the intervention group received a structured tele-rehabilitation program focusing on postural awareness exercises and pranayama-based breathing practices for eight weeks, while the control group did not receive any intervention during the study period. Primary outcomes include work-related ergonomic risk assessed using the Rapid Upper Limb Assessment (RULA) and cervical somatosensory function evaluated through cervical joint position sense (horizontal, vertical, and global error). Secondary outcomes include deep cervical flexor muscle endurance, perceived fatigue, postural awareness, and musical performance anxiety. Outcome measures were assessed at baseline and after the eight-week intervention period. The study aims to determine whether a tele-based postural awareness and breathing intervention can effectively reduce ergonomic risk and improve sensorimotor function in flute students who are exposed to prolonged asymmetric postures during instrument practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

December 24, 2025

Last Update Submit

January 29, 2026

Conditions

Keywords

Tele-rehabilitation, Postural Awareness, Ergonomic Risk, Cervical Proprioception, Musicians

Outcome Measures

Primary Outcomes (2)

  • Total RULA Score and RULA B Score

    Postural ergonomic risk is assessed during flute performance using the Rapid Upper Limb Assessment (RULA), which evaluates neck, trunk, and upper limb posture. The total RULA score ranges from 1 to 7, with higher scores indicating greater ergonomic risk.

    Baseline and 8 weeks

  • Cervical Somatosensory Function (Joint Position Sense - JPS)

    Cervical joint position sense is assessed using a laser-pointer repositioning method during flexion, extension, and rotation movements. Horizontal, vertical, and global angular errors are calculated. Higher error values indicate reduced proprioceptive accuracy.

    Baseline and 8 weeks

Secondary Outcomes (4)

  • Postural Habits and Awareness Scale (PAFÖ) total score

    Baseline and 8 weeks

  • Deep Cervical Flexor Muscle Endurance

    Baseline and 8 weeks

  • Modified Borg Scale score

    Baseline and 8 weeks

  • Kenny Music Performance Anxiety Inventory (K-MPAI) total score

    Baseline and 8 weeks

Study Arms (2)

No Intervention / Usual Activity

ACTIVE COMPARATOR

Participants do not receive any intervention and continue their usual daily activities and regular flute practice during the 8-week study period.

Other: No Intervention

Tele-Based Postural Awareness and Pranayama-Based Breathing Program

EXPERIMENTAL

Behavioral: Participants receive an 8-week tele-based program including postural awareness exercises and pranayama-based breathing practices delivered remotely.

Behavioral: Tele-Based Postural Awareness and Pranayama-Based Breathing Program

Interventions

An 8-week tele-rehabilitation program delivered remotely, focusing on postural awareness exercises and pranayama-based breathing practices.

Tele-Based Postural Awareness and Pranayama-Based Breathing Program

Participants do not receive any intervention and continue their usual daily activities and regular

No Intervention / Usual Activity

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 28 years
  • Enrolled as a student in the Department of Music at the Faculty of Fine Arts or Faculty of Education
  • Has been playing the flute for at least 3 years
  • Willing to participate in the study and able to provide informed consent

You may not qualify if:

  • History of upper extremity surgery
  • Presence of any diagnosed neurological disorder
  • History of cardiovascular disease
  • Presence of an acute musculoskeletal injury that could affect performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Alaaddin Keykubat University

Alanya, Antalya, 07425, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study Type: Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention Number of Arms: 2
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 8, 2026

Study Start

November 5, 2024

Primary Completion

January 15, 2025

Study Completion

May 30, 2025

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study involves small sample sizes and includes sensitive personal, performance, and health-related information. Data sharing could increase the risk of participant identification. In accordance with the approval of the institutional ethics committee and applicable data protection regulations, the data will be used only by the research team for the purposes of this study.

Locations