NCT02592044

Brief Summary

The effect of aromatherapy with lavender essential oil on pain and anxiety during venipuncture will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_4 pain

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

First Submitted

Initial submission to the registry

October 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

October 27, 2015

Last Update Submit

March 18, 2016

Conditions

Pain

Keywords

painanxietyCatheterization, Peripheral

Outcome Measures

Primary Outcomes (1)

  • Pain Level

    The pain of the patients during cannulation will be measured with Visual Analog Scale from 0 to 10.

    Within the first 5 minutes after the peripheral venous cannula insertion process

Secondary Outcomes (2)

  • Anxiety Level

    Within the first 5 minutes after the peripheral venous cannula insertion process

  • Patient Satisfaction

    Within the first 15 minutes after the peripheral venous cannula insertion process

Study Arms (2)

Aromatherapy with lavender essential oil

EXPERIMENTAL

The 2 drops of lavender essential oil will put on 5x5 cm gauze and the patient will inhale it for 5 minutes and during peripheral venous cannulation.

Procedure: peripheral venous cannulationProcedure: Aromatherapy with lavender essential oil

Placebo

PLACEBO COMPARATOR

The 2 drops water will put on 5x5 cm gauze ant the patient will inhale it for 5 minutes and during peripheral venous cannulation.

Procedure: peripheral venous cannulationProcedure: Placebo

Interventions

peripheral venous cannulationPROCEDURE

The 18 gauge venous cannula will be inserted in a peripheral vein on the back of right hand of the patient.

Also known as: cannulation
Aromatherapy with lavender essential oilPlacebo
Aromatherapy with lavender essential oilPROCEDURE

The two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation.

Also known as: lavender
Aromatherapy with lavender essential oil
PlaceboPROCEDURE

The two drops of water will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be scheduled for elective surgery
  • be accepted to inhale lavender

You may not qualify if:

  • age \<18 years \>65 years
  • preoperative pain or consumption of analgesic medication
  • anxiety disorders or consumption of anxiolytic medications (i.e. SSRI, benzodiazepine)
  • pregnancy or breastfeeding
  • asthma, chronic obstructive pulmonary disease
  • poor sense of smell
  • allergy to the lavender essential oil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University Medical School

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

CatheterizationAromatherapylavender oil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative TechniquesMind-Body TherapiesComplementary TherapiesPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tugba Karaman, MD

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 30, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 21, 2016

Record last verified: 2016-03

Locations

TU(1)