- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06779786
The Effect of Aromatherapy Applied to Intensive Care Nurses on Tension-Type Headache
The Effect of Aromatherapy Applied to Intensive Care Nurses on Tension-Type Headache and Quality of Life: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Nurses are healthcare professionals who provide 24-hour care to individuals and their families. This shift and watch working style of nurses is a situation that creates changes in their adaptation to biological, psychological and social life. Working in this way contradicts the body's normal biological rhythm and can cause physical disorders such as chronic fatigue, insomnia, exhaustion, depression and tension-type headache (TTH) and damage to the person's family and social life. One of the most common problems among these disorders is TTH (Jensen, 2018). Studies have shown that TTH is experienced by 31.7% to 61% of nurses . In a study conducted on night shifts and pain perception in nurses, it was determined that sleeplessness increased and the perceived pain level increased, especially in shifts held at 12-hour intervals . Pain is one of the important determinants of quality of life. It is emphasized that depression, insomnia, irritability, anxiety, inability to cope with stress, and deterioration in social relationships are more common in individuals with pain than in those without pain. In the study of it was stated that all sub-dimension scores of the SF 36 Quality of Life Scale were low in individuals with TTH.
Pharmacological methods are widely used in pain control. Studies have shown that there is an increase in the use of complementary and integrative treatment (CIT) methods or the willingness to use CIT methods together with pharmacological methods . When we look at the literature, CITs used in coping with pain include meditation, yoga, massage, deep breathing exercises, aromatherapy, relaxation exercises and applications such as reiki In some studies where CITs were applied; lavender inhalation applied to hemodialysis patients reduces the level of pain due to cannulation ; another study states that lavender oil inhalation applied for 15 minutes may be an effective and safe treatment method in the acute treatment of migraine headaches . Among these applications, aromatherapy massage has been one of the popular areas of TITs in recent systematic reviews (. In studies conducted with individuals diagnosed with cancer, it has been evaluated that aromatherapy massage applied significantly reduces the level of pain, and it has been determined that especially individuals who had pain before the application expressed relief after the application. The most commonly used essential oil in aromatherapy is medical lavender (Lavandula angustifolia) oil. It is stated that medicinal lavender, a powerful aromatic essential oil, has anti-inflammatory and analgesic effects. Studies on the subject have reported that aromatherapy massage applied with medicinal lavender is effective in reducing the pain of patients with many pain conditions such as infantile colic, dysmenorrhea and cancer pain, joint and headache . In a meta-analysis study, it was found that aroma inhalation applied by blending lavender, mint, lemon balm and various essential oils had a positive effect on reducing stress. Another meta-analysis study states that there are studies indicating that lavender oil reduces pain and anxiety when used by inhalation It has been determined that massage applied to individuals with burns and pain and aromatherapy applied with lavender oil significantly reduce the anxiety and pain levels of the individuals In a meta-analysis study examining the effect of aromatherapy massage in which lavender oil was used alone or with different oil mixtures in pain control;it was determined that the massage activated the parasympathetic nervous system, increased the level of hormones such as endorphin and serotonin in the blood and significantly reduced pain . Another aromatic oil used in pain management is eucalyptus striodora. It has been observed that eucalyptus striodora oil, with its pleasant smell and limonene compound, is a nervous system regulator and reduces pain in conditions such as neuralgia and headache.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bartın, Turkey, 74000
- Bartin University
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Kayseri, Turkey, 38000
- Erciyes University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Working in a tertiary ICU, able to communicate easily,
- Not pregnant,
- Scoring 3 or more on the VAS scale in two measurements,
- Meeting the TTH criteria defined by the International Headache Society,
- Headache Classification Committee, diagnosed with TTH by neurology,
- Experiencing pain as much as possible.
- Does not use analgesic drugs, complies with the analgesic usage schedule for a month,
- Does not have a diagnosed chronic disease that may affect the quality of life,
- Does not vary in the frequency of working shifts,
- Undertakes not to change the perfume used for a month.
- İndividuals who were not included in the preliminary application were included in the study.
Exclusion Criteria:
- Those who are allergic to the smell of medical lavender oil and eucalyptus sttriodora oil, those who cannot smell,
- Those who have a history of asthma, those who are diagnosed with migraine and use regular medication for headaches,
- Those who use other integrative health practices during the treatment process are not included in the application.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Other:Eucalyptus sttriodora oil Group (Aromatherapy Groups):
Description: Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of eucalyptus sttriodora (Group 1) oil, diluted with 3% sesame oil, is dropped into the palm of the hand, and after rubbing the hands together, rub the earlobe from top to bottom with the thumb and index finger for four minutes.
Massage application together and again by dropping 2 ml of 3% eucalyptus sttriodora (Intervention 1) oil into the palm.
These are groups that are given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands mutually.
|
Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of eucalyptus sttriodora (Group 1) oil, diluted with 3% sesame oil, is dropped into the palm of the hand, and after rubbing the hands together, rub the earlobe from top to bottom with the thumb and index finger for four minutes.
Massage application together and again by dropping 2 ml of 3% eucalyptus sttriodora (Intervention 1) oil into the palm.
These are groups that are given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands mutually.
|
|
Other: medicanal lavandula Oil group(Aromatherapy Groups):
Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of medicanal lavandula (Group 2) oil, diluted with 3% sesame oil, is dropped into the palm of the hand, and after rubbing the hands together, rub the earlobe from top to bottom with the thumb and index finger for four minutes.
Massage application together and again by dropping 2 ml of 3% medicanal lavandula (Intervention 1) oil into the palm.
These are groups that are given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands mutually.
|
Group 2(Aromatherapy Groups): Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of medicanal lavandula (Group 2) oil, diluted with 3% sesame oil, is dropped into the palm of the hand, and after rubbing the hands together, rub the earlobe from top to bottom with the thumb and index finger for four minutes.
Massage application together and again by dropping 2 ml of 3% medicanal lavandula (Intervention 1) oil into the palm.
These are groups that are given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands mutually.
|
|
Other: Other: Sesame oil group ( plesebo controloil Group)
Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of sesame oil is dropped into the palm of the hand and after rubbing the hands mutually, massage the earlobe from top to bottom with the thumb and index finger for four minutes, and again apply 2 ml of sesame oil into the palm.
The group was given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands together with the drops.
|
Self-administered by ICU nurses for four weeks, in the first week, every day in the morning and evening; In the second, third and fourth weeks, every day only in the morning, 2 ml of sesame oil is dropped into the palm of the hand and after rubbing the hands mutually, massage the earlobe from top to bottom with the thumb and index finger for four minutes, and again apply 2 ml of sesame oil into the palm.
The group was given a gentle massage of the cervical muscles from top to bottom for four minutes after rubbing the hands together with the drops.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
vas pain assessment-Visual Analog Scale (VAS)
Time Frame: one month
|
The VAS scale, was utilised to assess the pain levels of ICU nurses prior to and following the implementation of the intervention. The scale utilised a numerical scale ranging from '0', representing no pain, to '10', representing the most severe pain. The nurses experiencing pain were instructed to indicate on the VAS scale the point that most accurately reflected their pain at that moment, as recorded on the subsequent follow-up chart. the level of tension-type headache.In the present study, it was hypothesised that the mean score on the VAS pain scale would be lower in the aromatherapy intervention groups. |
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Short Form 36 (SF-36) Quality of Life Scale
Time Frame: one month
|
The subscale internal consistency coefficient of the scale was calculated as 0.924 for general health, 0.974 for physical function, 0.934 for physical role difficulty, 0.937 for emotional role difficulty, 0.937 for social function, 0.968 for pain, 0.785 for mental health and 0.945 for vitality. It is important to note that each sub-dimension of the scale is evaluated separately.In the present study, the total Cronbach alpha value of the scale was found to be 0.861. The Cronbach alpha value of the KF-36 Quality of Life Scale before the application was 0.889, while the Cronbach alpha value after the application was 0.861. In the present study, it was hypothesised that the score on the Short Form 36 (SF-36) Quality of Life Scale would be elevated in the aromatherapy intervention groups. |
one month
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BartınU-EmineÜstünGökçe-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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