Effect of Aromatherapy on Venopuncture Pain and Anxiety

Pain Clinical Trial

Official title:

Evaluation of the Effect of Aromatherapy With Lavender Essential Oil on Pain and Anxiety During Peripheral Venous Cannulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02592044
• Other study ID #: Venpuncture pain
• Status: Recruiting
• Phase: Phase 4
• First received: October 27, 2015
• Last updated: March 9, 2016
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Tokat Gaziosmanpasa University
• Contact: Tugba Karaman, MD
• Phone: +90 356 2129500
• Email: drtugbaguler[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa University Medical School	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Anxiety Level	The anxiety of the patient 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	No
Secondary	Patient Satisfaction	The patients' satisfaction will be measured with 5-point likert scale with 0 to 4.	Within the first 15 minutes after the peripheral venous cannula insertion process	No