NCT07738848

Brief Summary

This single-blinded, three-arm randomized controlled trial evaluated the effects of different auditory environments on laparoscopic task performance and mental workload among novice surgeons in a simulated setting. Sixty participants were randomly assigned to one of three groups: preferred music, white noise, or silent control. Participants completed standardized laparoscopic simulation tasks. The primary outcome was task completion time. Secondary outcomes included mental workload assessed using the Surgical Task Load Index (SURG-TLX), perceived stress, and heart rate variability. The study aimed to determine whether preferred music enhances technical performance while reducing cognitive workload during laparoscopic simulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 23, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

Preferred MusicWhite NoiseLaparoscopic SimulationSimulation TrainingSURG-TLXHeart Rate VariabilitySurgical Education

Outcome Measures

Primary Outcomes (1)

  • Laparoscopic task completion time

    Time required for participants to complete the standardized laparoscopic simulation task under the assigned auditory condition (preferred music, white noise, or silent control). Task completion time was recorded in seconds using the laparoscopic simulator's timing system.

    Immediately upon completion of the laparoscopic simulation task (Day 1).

Secondary Outcomes (4)

  • SURG-TLX score

    Immediately after completion of the laparoscopic simulation task (Day 1).

  • Heart Rate Variability

    Baseline (before simulation) and immediately after completion of the laparoscopic simulation task (Day 1).

  • Perceived Stress Score

    Baseline (before simulation) and immediately after completion of the laparoscopic simulation task (Day 1).

  • Technical Performance Score

    Baseline (before randomization) and immediately upon completion of the intervention laparoscopic simulation task (Day 1).

Study Arms (3)

Preferred Music

EXPERIMENTAL

Participants performed standardized laparoscopic simulation tasks while listening to their own self-selected preferred music through headphones throughout the simulation session.

Behavioral: Behavioral: Preferred Music

White Noise

EXPERIMENTAL

Participants performed standardized laparoscopic simulation tasks while listening to standardized white noise through headphones throughout the simulation session.

Behavioral: White Noise

Silent Control

EXPERIMENTAL

Participants performed standardized laparoscopic simulation tasks under standard silent conditions without any auditory stimulus.

Behavioral: SIlent Control

Interventions

Participants listened to their own self-selected preferred music through headphones while performing standardized laparoscopic simulation tasks. The music was chosen by each participant before the simulation and played continuously throughout the intervention session. The simulation protocol, task instructions, and assessment procedures were identical for all study groups.

Preferred Music
White NoiseBEHAVIORAL

Participants listened to standardized white noise through headphones while performing standardized laparoscopic simulation tasks. The white noise was played continuously throughout the intervention session. All simulation tasks, instructions, and assessment procedures were identical to those used in the other study groups.

White Noise
SIlent ControlBEHAVIORAL

Participants performed the standardized laparoscopic simulation tasks under a silent environment without exposure to any auditory stimulus. All simulation tasks, instructions, and assessment procedures were identical to those used in the intervention groups.

Silent Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • House officers or novice medical doctors
  • Previous exposure to surgical posting with basic laparoscopic experience
  • Able to understand study procedures
  • Willing to provide written informed consent

You may not qualify if:

  • Hearing impairment
  • Visual impairment affecting simulator use
  • Physical disability affecting laparoscopic performance
  • Current use of medications affecting autonomic nervous system function
  • Declined consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: preferred music, white noise, or silent control. Each participant completed the standardized laparoscopic simulation task under the assigned auditory condition only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Officer, Department of Surgery, Hospital Universiti Sains Malaysia

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 31, 2026

Study Start

March 2, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

De-identified participant data will be made available from the corresponding author upon reasonable request, subject to institutional and ethical approval.

Locations