PainNCT04151576
Aromatherapy Massage in Migraine Attacks
A study testing aromatherapy massage in people with Pain and Head Pain, run by Biruni University.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain, Head Pain, Quality of Life
- What is being tested?
- aromatherapy massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Effect of Aromatherapy Massage on the Pain Severity and Quality of Life in Acute Migraine Attacks
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.
Read the 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.
- Conditions
- Pain, Head Pain, Quality of Life
- Being tested
- aromatherapy massage
- Keywords
- aromatherapy, massage
- Medical subject headings
- Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatherapy massageOther
aromatherapy massage
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: aromatherapy massage |
| Control | No intervention | The patients received only medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Dec 2016
- Primary completion1 Jan 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experiment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Halic University, Bitlis Eren University
- Responsible party
- Principal investigator, Leman Şenturan, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151576
- Sponsor's protocol ID
- Biruni U
- Status last verified
- Dec 2019
- First submitted
- 1 Nov 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy Massage on the Pain Severity and Quality of Life in Acute Migraine Attacks
- ClinicalTrials.gov ID
- NCT04151576
- Acronym / sponsor ID
- Biruni U
- Conditions
- Pain, Head Pain, Quality of Life
- Keywords
- aromatherapy, massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Halic University, Bitlis Eren University
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled experiment.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: aromatherapy massageThe 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 |
| Control | No intervention | –The patients received only medical treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aromatherapy massagearomatherapy massage | Other | Experimental |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing aromatherapy massage in people with Pain and Head Pain, run by Biruni University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.