Laparoscopic Surgery SimulationNCT07738848
Impact of Preferred Music on Laparoscopic Task Performance and Mental Workload in Novice Surgeons
A study testing Behavioral: Preferred Music and White Noise in people with Laparoscopic Surgery Simulation and Mental Workload, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgery Simulation, Mental Workload, Stress
- What is being tested?
- Behavioral: Preferred Music and White Noise
- 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 siteMalaysia
- Study dates
- 2 Mar 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hearing impairment
- Visual impairment affecting simulator use
- Physical disability affecting laparoscopic performance
- Current use of medications affecting autonomic nervous system function
- Declined consent
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
About this study
Official title: Impact of Preferred Music on Laparoscopic Task Performance and Mental Workload in Simulated Setting: A Single-Blinded Randomized Controlled Trial
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.
Read the detailed description
Background Laparoscopic surgery requires advanced psychomotor coordination, sustained concentration, and effective stress management. Environmental auditory stimuli may influence cognitive performance and operative efficiency, yet evidence remains limited, particularly among novice surgeons.
Objective To compare the effects of preferred music, white noise, and silence on laparoscopic performance and mental workload.
Methods Participants were randomized equally into three intervention groups. All participants performed standardized laparoscopic simulation exercises under their assigned auditory condition. Technical performance, subjective workload, and physiological stress were evaluated using validated assessment tools.
Hypothesis Preferred music improves laparoscopic performance and reduces mental workload compared with white noise or silence.
- Being tested
- Behavioral: Preferred Music, White Noise, SIlent Control
- Keywords
- Preferred Music, White Noise, Laparoscopic Simulation, Simulation Training, SURG-TLX, Heart Rate Variability, Surgical Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Preferred MusicBehavioural
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.
White NoiseBehavioural
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.
SIlent ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Preferred Music | Experimental | Participants performed standardized laparoscopic simulation tasks while listening to their own self-selected preferred music through headphones throughout the simulation session. Receives: 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. Receives: Behavioral: White Noise |
| Silent Control | Experimental | Participants performed standardized laparoscopic simulation tasks under standard silent conditions without any auditory stimulus. Receives: Behavioral: SIlent Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately upon completion of the laparoscopic simulation task (Day 1).
Secondary outcomes (4)
SURG-TLX score
Mental workload measured using the Surgical Task Load Index (SURG-TLX) questionnaire. The SURG-TLX generates a weighted overall workload score ranging from 0 to 10, with higher scores indicating greater mental workload (worse outcome).
Measured: Immediately after completion of the laparoscopic simulation task (Day 1).
Heart Rate Variability
Heart rate variability parameters were measured using a validated heart rate monitoring device before and after the laparoscopic simulation to assess autonomic nervous system activity. Outcomes included time-domain and frequency-domain HRV indices. The direction of better or worse outcome depends on the specific HRV parameter analyzed.
Measured: Baseline (before simulation) and immediately after completion of the laparoscopic simulation task (Day 1).
Perceived Stress Score
Subjective stress assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no perceived stress and 10 indicates the highest perceived stress. Higher scores indicate greater perceived stress (worse outcome).
Measured: Baseline (before simulation) and immediately after completion of the laparoscopic simulation task (Day 1).
Technical Performance Score
Overall technical performance assessed using the LapSim laparoscopic simulator. The LapSim overall performance score is an automatically generated composite score based on performance metrics including task completion, instrument handling, movement efficiency, accuracy, and errors. Scores range from 0 to 100, with higher scores indicating better laparoscopic technical performance.
Measured: Baseline (before randomization) and immediately upon completion of the intervention laparoscopic simulation task (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start2 Mar 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Surgery SimulationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GAN CHOON HUI, Hospital Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738848
- Sponsor's protocol ID
- USM/JEPeM/KK/24070566
- Other IDs
- USM/JEPeM/KK/24070566
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified participant data will be made available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preferred Music on Laparoscopic Task Performance and Mental Workload in Simulated Setting: A Single-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07738848
- Acronym / sponsor ID
- USM/JEPeM/KK/24070566
- Keywords
- Preferred Music, White Noise, Laparoscopic Simulation, Simulation Training, SURG-TLX, Heart Rate Variability, Surgical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 31 Jul 2026 (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 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.
Detailed description
Background Laparoscopic surgery requires advanced psychomotor coordination, sustained concentration, and effective stress management. Environmental auditory stimuli may influence cognitive performance and operative efficiency, yet evidence remains limited, particularly among novice surgeons.
Objective To compare the effects of preferred music, white noise, and silence on laparoscopic performance and mental workload.
Methods Participants were randomized equally into three intervention groups. All participants performed standardized laparoscopic simulation exercises under their assigned auditory condition. Technical performance, subjective workload, and physiological stress were evaluated using validated assessment tools.
Hypothesis Preferred music improves laparoscopic performance and reduces mental workload compared with white noise or silence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Preferred Music | Experimental | Behavioral: Behavioral: Preferred MusicParticipants performed standardized laparoscopic simulation tasks while listening to their own self-selected preferred music through headphones throughout the simulation session. |
| White Noise | Experimental | Behavioral: White NoiseParticipants performed standardized laparoscopic simulation tasks while listening to standardized white noise through headphones throughout the simulation session. |
| Silent Control | Experimental | Behavioral: SIlent ControlParticipants performed standardized laparoscopic simulation tasks under standard silent conditions without any auditory stimulus. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Hearing impairment
- Visual impairment affecting simulator use
- Physical disability affecting laparoscopic performance
- Current use of medications affecting autonomic nervous system function
- Declined consent
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 |
|---|---|---|
| Behavioral: Preferred MusicParticipants 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. | Behavioural | Preferred Music |
| White NoiseParticipants 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. | Behavioural | White Noise |
| SIlent ControlParticipants 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. | Behavioural | Silent Control |
Primary outcome
Laparoscopic task completion time
Time frame: Immediately upon completion of the laparoscopic simulation task (Day 1).
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.
4 secondary outcomes
SURG-TLX score
Time frame: Immediately after completion of the laparoscopic simulation task (Day 1).
Heart Rate Variability
Time frame: Baseline (before simulation) and immediately after completion of the laparoscopic simulation task (Day 1).
Perceived Stress Score
Time frame: Baseline (before simulation) and immediately after completion of the laparoscopic simulation task (Day 1).
Technical Performance Score
Time frame: Baseline (before randomization) and immediately upon completion of the intervention laparoscopic simulation task (Day 1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No. De-identified participant data will be made available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
Related trials for Laparoscopic Surgery Simulation
Active, not recruiting
Structured Simulation Training for Laparoscopic and Thoracoscopic Skills in Thoracic Surgery Residents
Surgical Education, Simulation-based Training
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Preferred Music and White Noise in people with Laparoscopic Surgery Simulation and Mental Workload, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 31 Jul 2026. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laparoscopic task completion time (time frame: Immediately upon completion of the laparoscopic simulation task (Day 1).). 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 31 Jul 2026.