Aromatherapy Massage in Migraine Attacks

• ClinicalTrials.gov Identifier: NCT04151576
• Recruitment Status: Completed
• First Posted: November 5, 2019
• Last Update Posted: December 18, 2019
• Sponsor: Biruni University
• Collaborators: Halic University; Bitlis Eren University
• Information provided by (Responsible Party): Leman Şenturan, Biruni University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pain; Head Pain; Quality of Life	Other: aromatherapy massage	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled experiment.
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Aromatherapy Massage on the Pain Severity and Quality of Life in Acute Migraine Attacks
• Actual Study Start Date: December 1, 2016
• Actual Primary Completion Date: January 1, 2018
• Actual Study Completion Date: June 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental; The patients received medical treatment. The intervention: An aromatic oil mixture (lavender and peppermint) was massaged for 15 minutes on the temple and root of the neck of the patients, and this application continued for three weeks	Other: aromatherapy massage; aromatherapy massage
No Intervention: Control; The patients received only medical treatment

Outcome Measures

Primary Outcome Measures :

1. 24-Hour Migraine Quality of Life [ Time Frame: 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. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Leman Şenturan, Prof. Dr., Biruni University
• ClinicalTrials.gov Identifier: NCT04151576
• Other Study ID Numbers: Biruni U
• First Posted: November 5, 2019
• Last Update Posted: December 18, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leman Şenturan, Biruni University:

aromatherapy; massage