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Trial record 17 of 237 for:    essential oil

Effect of Aromatherapy on Venopuncture Pain and Anxiety

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ClinicalTrials.gov Identifier: NCT02592044
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Tuğba Karaman, Tokat Gaziosmanpasa University

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

Condition or disease Intervention/treatment Phase
Pain Procedure: peripheral venous cannulation Procedure: Aromatherapy with lavender essential oil Procedure: Placebo Phase 4

Detailed Description:
The anxiety and pain during venipuncture may be cause to the avoidance of the medical therapy in patient as well as adult. Aromatherapy with lavender was shown that beneficial effects on chronic pain and anxiety. It's effect on acute pain and anxiety is not exactly known. In this study, the aromatherapy with the lavender will be compared with placebo to evaluate the analgesic and anxiolytic effect during peripheral venous cannulation before surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Aromatherapy With Lavender Essential Oil on Pain and Anxiety During Peripheral Venous Cannulation
Study Start Date : November 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Aromatherapy with lavender essential oil
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 cannulation
The 18 gauge venous cannula will be inserted in a peripheral vein on the back of right hand of the patient.
Other Name: cannulation

Procedure: Aromatherapy with lavender essential oil
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.
Other Name: lavender

Placebo Comparator: Placebo
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 cannulation
The 18 gauge venous cannula will be inserted in a peripheral vein on the back of right hand of the patient.
Other Name: cannulation

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




Primary Outcome Measures :
  1. Pain Level [ Time Frame: Within the first 5 minutes after the peripheral venous cannula insertion process ]
    The pain of the patients during cannulation will be measured with Visual Analog Scale from 0 to 10.


Secondary Outcome Measures :
  1. Anxiety Level [ Time Frame: Within the first 5 minutes after the peripheral venous cannula insertion process ]
    The anxiety of the patient during cannulation will be measured with Visual Analog Scale from 0 to 10.

  2. Patient Satisfaction [ Time Frame: Within the first 15 minutes after the peripheral venous cannula insertion process ]
    The patients' satisfaction will be measured with 5-point likert scale with 0 to 4.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592044


Locations
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Turkey
Gaziosmanpasa University Medical School
Tokat, Turkey, 60100
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
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Principal Investigator: Tugba Karaman, MD Gaziosmanpasa University

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Responsible Party: Tuğba Karaman, Assistant Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT02592044     History of Changes
Other Study ID Numbers: Venpuncture pain
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016
Keywords provided by Tuğba Karaman, Tokat Gaziosmanpasa University:
pain
anxiety
Catheterization, Peripheral
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders