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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04151576
Other study ID # Biruni U
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2016
Est. completion date June 1, 2018

Study information

Verified date December 2019
Source Biruni University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study was to determine the effect of aromatherapy massage on the pain severity and quality of life in patients diagnosed with migraine in addition to medical treatment during an acute migraine attack.

In addition to medical treatments, complementary and supportive therapies are commonly used to cope with pain during a migraine attack. In recent years, aromatherapy through massage has become more common to reduce the severity of pain, make the patient painless and improve the quality of life. Aromatherapy applications are the application of pain relief oil mixtures through massage. Lavender and peppermint essential oils are mostly used in aromatherapy applications to reduce pain. Therefore, a mixture of mint and lavender oil was used in the study.


Description:

The study was planned and conducted as a randomized controlled experiment. The sample of the randomized controlled trial consisted of 70 patients who applied to the emergency department with a migraine attack and met the study criteria. Data were collected via Patient Information Form, 24-Hour Migraine Quality of Life Scale, Visual Analogue Scale, Sphygmomanometer, and Pulse oximeter. Along with the medical treatment, patients of experimental group were massaged for 15 minutes with an aromatic oil mixture (lavender and peppermint) applied on the temple and root of the neck, and this application continued for three weeks. Control group patients, however, received only medical treatment. Descriptive statistics methods, Shapiro Wilks test, Wilcoxon Signed Ranks Test, Mann Whitney U Test, Kruskal Wallis Test, Fisher's Exact Test and Chi-Square Test were used for data evaluation.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date June 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

diagnosed with migraine according to International Headache Society 2013 Being able to speak Turkish, being between the ages of 18 and 50, being literate, not having any communication problems, agreeing to participate in the study, having vital signs within normal limits not being diagnosed with a psychiatric disorder

Exclusion Criteria:

having a headache other than migraine being the ages under the 18 having any communication problems, having vital signs above or under normal limits being diagnosed with a psychiatric disorder

Study Design


Related Conditions & MeSH terms


Intervention

Other:
aromatherapy massage
aromatherapy massage

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Biruni University Bitlis Eren University, Halic University

Outcome

Type Measure Description Time frame Safety issue
Primary 24-Hour Migraine Quality of Life The scale measures the change in quality of life for 24 hours after medication to relieve migraine headache.There are a total of 15 questions on the 7 Point Likert Scale. The scale has five domains for the quality of life, each with three items. These are migraine symptoms, emotions-concerns, work functioning, social functioning and energy-vitality. After 30 minutes of medical treatment and massage, blood pressure, oxygen saturation and pain were reevaluated and "24-Hour Migraine Quality of Life Scale" was administered.
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