Patient SatisfactionNCT02958826

Impact of Sensory Stimuli on Patient Preferences During Outpatient Surgery

An observational study of Patient Satisfaction, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine the effect surgical lights, surgical smoke, and surgical sounds have on patient satisfaction with their outpatient Mohs surgical procedure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Patient Satisfaction
What is being tested?: Questionnaire
How many people: 160 participants
Where: 1 siteUnited States
Study dates: Oct 2016to 1 Jul 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All adult (> 18 years old) patients presenting for Mohs surgery and reconstruction for the treatment of nonmelanoma skin cancer on the head and neck.

Who may be able to join

All adult (> 18 years old) patients presenting for Mohs surgery and reconstruction for the treatment of nonmelanoma skin cancer on the head and neck

Who cannot join

Subjects not meeting inclusion criteria.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Missouri-Columbia
Columbia, Missouri, 65212

Other trials in United States

About this study

Official title: Determining the Impact of External Sensory Stimuli on Patient Preferences During Outpatient Surgery

The purpose of this study is to determine the effect surgical lights, surgical smoke, and surgical sounds have on patient satisfaction with their outpatient Mohs surgical procedure.

Read the detailed description

The purpose of this study is to determine the impact of external sensory stimuli on patient preferences during outpatient Mohs surgery. Study participants will be asked to complete a questionnaire after their procedure sharing their experience with surgical lights, surgical smoke, and surgical noise. All responses are anonymous.

Conditions: Patient Satisfaction
Being tested: Questionnaire
Medical subject headings: Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuestionnaireOther
Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure.

Study groups in NCT02958826
Study group	Role	What they receive
No Smoke Evacuation		No Smoke Evacuation Group, anonymous questionnaire administered Receives: Other: Questionnaire
Smoke Evacuation		Smoke Evacuation Group, anonymous questionnaire administered Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of Surgical Lights on Patient Preference
Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical lights.
Measured: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.
Effects of Surgical Smoke on Patient Preference
Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical smoke.
Measured: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.
Effect of Surgical Sounds on Patient Preference
Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical sounds.
Measured: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 20161 Jul 2017

First posted8 Nov 2016 (estimated)
Study startOct 2016
Primary completion1 Jul 2017
Study completion1 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Patient SatisfactionStudies of the same condition, open and under way.
More trials run by University of Missouri-ColumbiaThe 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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02958826
Sponsor's protocol ID: 2005623
Status last verified: Sep 2018
First submitted: 2 Nov 2016
Last updated: 15 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determining the Impact of External Sensory Stimuli on Patient Preferences During Outpatient Surgery
ClinicalTrials.gov ID: NCT02958826
Acronym / sponsor ID: 2005623
Conditions: Patient Satisfaction
Study type: Observational
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Study start: Oct 2016 (actual)
Primary completion: 1 Jul 2017 (actual)
Study completion: 1 Jul 2017 (actual)
First posted: 8 Nov 2016 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the effect surgical lights, surgical smoke, and surgical sounds have on patient satisfaction with their outpatient Mohs surgical procedure.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
No Smoke Evacuation	–	Other: QuestionnaireNo Smoke Evacuation Group, anonymous questionnaire administered
Smoke Evacuation	–	Other: QuestionnaireSmoke Evacuation Group, anonymous questionnaire administered

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All adult (> 18 years old) patients presenting for Mohs surgery and reconstruction for the treatment of nonmelanoma skin cancer on the head and neck.

Key inclusion criteria (1 listed)

All adult (> 18 years old) patients presenting for Mohs surgery and reconstruction for the treatment of nonmelanoma skin cancer on the head and neck

Key exclusion criteria (1 listed)

Subjects not meeting inclusion criteria.

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
QuestionnaireAnonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure.	Other	No Smoke Evacuation, Smoke Evacuation

Primary outcome

Effect of Surgical Lights on Patient Preference
Time frame: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.
Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical lights.
Effects of Surgical Smoke on Patient Preference
Time frame: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.
Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical smoke.
Effect of Surgical Sounds on Patient Preference
Time frame: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.
Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical sounds.

Results and safety

Results posted to the registry on 15 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Smoke Evacuation Group	80	80
Control Group	80	80

Primary outcome: Effect of Surgical Lights on Patient Preference

Time frame: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.. Number. Unit: percentage of participants

Measure	No Smoke Evacuation n = 80	Smoke Evacuation n = 80
Did not notice lights	37.7	46.8
Were not bothered by lights	0.00	1.3
Experience would not be improved if lights changed	0.00	1.3

Primary outcome: Effects of Surgical Smoke on Patient Preference

Measure	Smoke Evacuation Group n = 80	Control Group n = 80
Did Not Notice Smoke Smell	71.8	41.6
Were Not Bothered by Smoke Smell	93.6	75.0
Would Not be More Satisfied with Smoke Evacuation	89.6	77.3

Population analysed: Frequency of participants.

Primary outcome: Effect of Surgical Sounds on Patient Preference

Measure	No Smoke Evacuation n = 80	Smoke Evacuation n = 80
Did not notice sounds	51.9	50.0
Were not bothered by sounds	90.9	88.2
Would not be more satisfied if sounds reduced	93.2	84.2

Adverse events

Time frame: Adverse data were collected on the day of surgery for the time required to complete the procedure and questionnaire. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Smoke Evacuation Group	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Control Group	0 of 80 (0%)	0 of 80 (0%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Nicholas Golda, MD principal investigator

University of Missouri-Columbia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Patient Satisfaction, run by University of Missouri-Columbia at 1 site in United States.

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 1 inclusion and 1 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 15 Feb 2019. 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 United States. 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?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Effect of Surgical Lights on Patient Preference (time frame: Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02958826.

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 15 Feb 2019.