NCT00417001

Brief Summary

Colonoscopy for investigation of lower gastrointestinal complaints or for colon cancer screening is one of the more frequent procedures performed by the Divisions of General Surgery and Gastroenterology. Traditionally, this has been performed while under conscious sedation (medication induced) which may improve patient acceptance and tolerance of the procedure but adds to the operative risk of the procedure. The investigators propose a randomized prospective blinded trial to assess the utility of adding pleasing olfactory stimulation to the inhaled oxygen during the conscious sedation for colonoscopy in an effort to reduce the total doses of sedatives required while maintaining a similar level of sedation. This may decrease the overall period of recovery for the patient, increase the number of procedures which may be accomplished, and decrease the potential complications related to conscious sedation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

December 27, 2006

Last Update Submit

August 12, 2025

Conditions

Colon Cancer ScreeningColon Polyps

Keywords

sedationcolonoscopyAroma therapy

Interventions

Aroma therapyPROCEDURE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient's presenting for colon cancer screening, colon cancer follow up colonoscopy, or polyp follow up colonoscopy

You may not qualify if:

  • Allergy to Demerol or Versed, symptomatic colon disease, allergy to a component in the aroma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center Department of Surgery

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Paul A Lucha, DO

    Naval Medical Center Department of Surgery- Portsmouth, VA

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2006

First Posted

December 28, 2006

Study Start

October 1, 2006

Primary Completion

January 1, 2008

Study Completion

October 1, 2008

Last Updated

August 17, 2025

Record last verified: 2025-08

Locations

US(1)