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Aromatherapy Massage in Migraine Attacks

Primary Purpose

Pain, Head Pain, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aromatherapy massage
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring aromatherapy, massage

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental

    Control

    Arm Description

    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

    The patients received only medical treatment

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2019
    Last Updated
    December 16, 2019
    Sponsor
    Biruni University
    Collaborators
    Halic University, Bitlis Eren University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04151576
    Brief Title
    Aromatherapy Massage in Migraine Attacks
    Official Title
    The Effect of Aromatherapy Massage on the Pain Severity and Quality of Life in Acute Migraine Attacks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2016 (Actual)
    Primary Completion Date
    January 1, 2018 (Actual)
    Study Completion Date
    June 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Biruni University
    Collaborators
    Halic University, Bitlis Eren University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Head Pain, Quality of Life
    Keywords
    aromatherapy, massage

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled experiment.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    83 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The patients received only medical treatment
    Intervention Type
    Other
    Intervention Name(s)
    aromatherapy massage
    Intervention Description
    aromatherapy massage
    Primary Outcome Measure Information:
    Title
    24-Hour Migraine Quality of Life
    Description
    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.
    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.

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Aromatherapy Massage in Migraine Attacks

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