BurnsNCT04237285
Effectiveness of Inhalation Aromatherapy In Children With Burns
A study testing Inhalation aromatherapy in people with Burns, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The study was carried out in the Pediatric Burn Unit, aged between 2 months and 7 years, with no chronic pain, second degree superficial scald burns, hydrotherapy application, no burn surgery, no pathogen growth in the burn site, the burn had not undergone epithelialization. Read more about this study
- Who is it for?
- Ages 2 months to 7 years
- Conditions the study is for
- Burns
- What is being tested?
- Inhalation aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 1 Sep 2019
- 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 2 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 2 months-7 years,
- having a second degree of superficial burn,
- willing to participate in the study,
- receiving hydrotherapy application (wet dressing),
- dressing the child with the same dressing material,
- having no chronic pain,
Show all 11Show fewer
- having scalding burn,
- having no surgery record to treat burns,
- having no pathogen reproduction at the burn area,
- having no stage of epitheliazation,
- having analgesic therapy containing the same active substance.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Behcet Uz Children's Hospital
Izmir, 35640
About this study
Official title: Effectiveness of Inhalation Aromatherapy In Children With Burns: A Randomized Controlled Trial
The study was carried out in the Pediatric Burn Unit, aged between 2 months and 7 years, with no chronic pain, second degree superficial scald burns, hydrotherapy application, no burn surgery, no pathogen growth in the burn site, the burn had not undergone epithelialization. Children receiving routine analgesic therapy were included.
Lavender oil 15 minutes, Lavender oil 60 minutes and Jojoba oil 15 minutes (Placebo group) were studied with a total of 108 children in three groups.
The children included in the study were randomized. One of the researchers measured the pain and vital signs of children before the application. 0.5 cc of aromatherapy oil, which was dripped into the gauze 15 or 60 minutes before the start of hydrotherapy and dressing, was placed 20 cm away from the child's nose. The child who inhaled the smell was hydrotherapy and dressing and then taken to bed. The other investigator, who did not know how long the child inhaled in the morning, evaluated pain and vital signs 1 and 30 minutes after the child returned to bed.
Read the detailed description
This randomized clinical trial research experimental design was performed with pediatric burn patients on May 2018-May 2019. Routine treatment of any child was not interfered with during the data collection phase of the study.
Sample
The minimum sample size in each intervention and control group was considered 36 using G power formula with a = 0.05, power of 80%, 95% confidence interval (Gpower 3.1.9.2., Germany). Allocation to the groups was performed using the Stratified Randomization. The absence of differences in age, vital signs and pain levels between groups prior to the intervention was achieved using Stratified Randomization method.
Intervention Protocols
In the clinic where the study was conducted, all children are routinely given hydrotherapy treatment for the examination of the burn area as of 10 am every morning and then dressings are applied.
Besides routine care, the Control Group was treated with jojoba oil (Simmondsia Chinensis- produced by Arifoğlu, obtained from jojoba fruits by cold squeezing method) inhalation aromatherapy 15 minutes before Hydrotherapy. Jojoba oil was used as a placebo because it had no specific odour. Besides routine care, Intervention-15 Group received lavender oil (Lavandula angustifolia Miller Oleum-produced by Arifoğlu, obtained from lavender flowers by water vapour distillation method) inhalation aromatherapy 15 minutes before Hydrotherapy and besides routine care, Intervention-60 Group received lavender oil inhalation aromatherapy 60 minutes before Hydrotherapy. 0.5 ml (8.44 minim-imperial) of aromatherapy oil, which had been dripped into 7.5x7.5 cm gauze 15 or 60 minutes before the start of Hydrotherapy, was placed 20 cm (7.87 inches) away from the child's nose by the clinical nurse. To conceal the allocation, the group in which the child belongs is only known to the clinical nurse who has placed the aromatherapy oil-soaked gauze in the child's room and this clinical nurse did not carry out any assessment of the child's outcomes.
Data Collection
Before randomization, the characteristics of all participants were collected using the Turkish version of the FLACC Pain Scale, Demographic Data Collection Form, and the Vital Signs Follow-up Form which were developed by the researchers.
By the clinical nurse 0.5 ccs of aromatherapy oil, which had dripped into the gauze, was placed 20 cm away from the child's nose. The child who inhaled the oil was then taken to hydrotherapy and then dressing. The pain and vital signs of the child were evaluated and recorded 1 minute and 30 minutes after the child returned to bed by a researcher who was blind to the study groups.
- Conditions
- Burns
- Being tested
- Inhalation aromatherapy
- Keywords
- pediatric, aromatherapy
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation aromatherapyOther
Besides routine care, the Control Group was treated with jojoba oil (Simmondsia Chinensis- produced by Arifoğlu, obtained from jojoba fruits by cold squeezing method) inhalation aromatherapy 15 minutes before Hydrotherapy. Jojoba oil was used as a placebo because it had no specific odor. Besides routine care Intervention-15 Group received lavender oil (Lavandula angustifolia Miller Oleum-produced by Arifoğlu, obtained from lavender flowers by water vapor distillation method) inhalation aromatherapy 15 minutes before Hydrotherapy and besides routine care Intervention-60 Group received lavender oil inhalation aromatherapy 60 minutes before Hydrotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Lavender 15 | Experimental | Participant who inhalates lavender oil for 15 minutes. Receives: Other: Inhalation aromatherapy |
| Lavender 60 | Experimental | Participant who inhalates lavender oil for 60 minutes. Receives: Other: Inhalation aromatherapy |
| Jojoba | Placebo comparator | Participant who inhalates jojoba oil for 15 minutes. Receives: Other: Inhalation aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial pressure
The mean arterial pressure of the child was evaluated and recorded before dressing, also 1 and 30 minutes after the dressing.
Measured: 1 day
body temperature
The body temperature of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
Measured: 1 day
heart rate
The heart rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
Measured: 1 day
respiratory rate
The respiratory rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
Measured: 1 day
FLACC Pain Scale Scores
The FLACC Pain Scale scores of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
FLACC (The Face, Legs, Activity, Cry, Consolability Scale) Pain Scale used by Merkel et al in 1997 in children between 2 months-7 years of age. With this scale, five behavioral criteria such as facial expression, the position of legs, movements, crying and comforting are evaluated. Each episode is rated 0-2 with scores ranging from 0-10 in total, the lower the score, the less pain is said .0 points:" no pain "1-3 points:" there is little pain "4-6 points:" there is moderate pain " 7-10 points:" there is much pain".
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 May 2018
- Primary completion1 May 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Behcet Uz Children's Hospital
- Responsible party
- Principal investigator, ESRA ARDAHAN AKGUL, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237285
- Sponsor's protocol ID
- 2018/201
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 27 Jan 2020
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Inhalation Aromatherapy In Children With Burns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04237285
- Acronym / sponsor ID
- 2018/201
- Conditions
- Burns
- Keywords
- pediatric, aromatherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- Dr. Behcet Uz Children's Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 23 Jan 2020 (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 study was carried out in the Pediatric Burn Unit, aged between 2 months and 7 years, with no chronic pain, second degree superficial scald burns, hydrotherapy application, no burn surgery, no pathogen growth in the burn site, the burn had not undergone epithelialization. Children receiving routine analgesic therapy were included.
Lavender oil 15 minutes, Lavender oil 60 minutes and Jojoba oil 15 minutes (Placebo group) were studied with a total of 108 children in three groups.
The children included in the study were randomized. One of the researchers measured the pain and vital signs of children before the application. 0.5 cc of aromatherapy oil, which was dripped into the gauze 15 or 60 minutes before the start of hydrotherapy and dressing, was placed 20 cm away from the child's nose. The child who inhaled the smell was hydrotherapy and dressing and then taken to bed. The other investigator, who did not know how long the child inhaled in the morning, evaluated pain and vital signs 1 and 30 minutes after the child returned to bed.
Detailed description
This randomized clinical trial research experimental design was performed with pediatric burn patients on May 2018-May 2019. Routine treatment of any child was not interfered with during the data collection phase of the study.
Sample
The minimum sample size in each intervention and control group was considered 36 using G power formula with a = 0.05, power of 80%, 95% confidence interval (Gpower 3.1.9.2., Germany). Allocation to the groups was performed using the Stratified Randomization. The absence of differences in age, vital signs and pain levels between groups prior to the intervention was achieved using Stratified Randomization method.
Intervention Protocols
In the clinic where the study was conducted, all children are routinely given hydrotherapy treatment for the examination of the burn area as of 10 am every morning and then dressings are applied.
Besides routine care, the Control Group was treated with jojoba oil (Simmondsia Chinensis- produced by Arifoğlu, obtained from jojoba fruits by cold squeezing method) inhalation aromatherapy 15 minutes before Hydrotherapy. Jojoba oil was used as a placebo because it had no specific odour. Besides routine care, Intervention-15 Group received lavender oil (Lavandula angustifolia Miller Oleum-produced by Arifoğlu, obtained from lavender flowers by water vapour distillation method) inhalation aromatherapy 15 minutes before Hydrotherapy and besides routine care, Intervention-60 Group received lavender oil inhalation aromatherapy 60 minutes before Hydrotherapy. 0.5 ml (8.44 minim-imperial) of aromatherapy oil, which had been dripped into 7.5x7.5 cm gauze 15 or 60 minutes before the start of Hydrotherapy, was placed 20 cm (7.87 inches) away from the child's nose by the clinical nurse. To conceal the allocation, the group in which the child belongs is only known to the clinical nurse who has placed the aromatherapy oil-soaked gauze in the child's room and this clinical nurse did not carry out any assessment of the child's outcomes.
Data Collection
Before randomization, the characteristics of all participants were collected using the Turkish version of the FLACC Pain Scale, Demographic Data Collection Form, and the Vital Signs Follow-up Form which were developed by the researchers.
By the clinical nurse 0.5 ccs of aromatherapy oil, which had dripped into the gauze, was placed 20 cm away from the child's nose. The child who inhaled the oil was then taken to hydrotherapy and then dressing. The pain and vital signs of the child were evaluated and recorded 1 minute and 30 minutes after the child returned to bed by a researcher who was blind to the study groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lavender 15 | Experimental | Other: Inhalation aromatherapyParticipant who inhalates lavender oil for 15 minutes. |
| Lavender 60 | Experimental | Other: Inhalation aromatherapyParticipant who inhalates lavender oil for 60 minutes. |
| Jojoba | Placebo comparator | Other: Inhalation aromatherapyParticipant who inhalates jojoba oil for 15 minutes. |
Who may qualify
- Ages
- 2 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- aged 2 months-7 years,
- having a second degree of superficial burn,
- willing to participate in the study,
- receiving hydrotherapy application (wet dressing),
- dressing the child with the same dressing material,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Inhalation aromatherapyBesides routine care, the Control Group was treated with jojoba oil (Simmondsia Chinensis- produced by Arifoğlu, obtained from jojoba fruits by cold squeezing method) inhalation aromatherapy 15 minutes before Hydrotherapy. Jojoba oil was used as a placebo because it had no specific odor. Besides routine care Intervention-15 Group received lavender oil (Lavandula angustifolia Miller Oleum-produced by Arifoğlu, obtained from lavender flowers by water vapor distillation method) inhalation aromatherapy 15 minutes before Hydrotherapy and besides routine care Intervention-60 Group received lavender oil inhalation aromatherapy 60 minutes before Hydrotherapy. | Other | Jojoba, Lavender 15, Lavender 60 |
Primary outcome
mean arterial pressure
Time frame: 1 day
The mean arterial pressure of the child was evaluated and recorded before dressing, also 1 and 30 minutes after the dressing.
body temperature
Time frame: 1 day
The body temperature of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
heart rate
Time frame: 1 day
The heart rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
respiratory rate
Time frame: 1 day
The respiratory rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
FLACC Pain Scale Scores
Time frame: 1 day
The FLACC Pain Scale scores of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing. FLACC (The Face, Legs, Activity, Cry, Consolability Scale) Pain Scale used by Merkel et al in 1997 in children between 2 months-7 years of age. With this scale, five behavioral criteria such as facial expression, the position of legs, movements, crying and comforting are evaluated. Each episode is rated 0-2 with scores ranging from 0-10 in total, the lower the score, the less pain is said .0 points:" no pain "1-3 points:" there is little pain "4-6 points:" there is moderate pain " 7-10 points:" there is much pain".
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 27 Jan 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation aromatherapy in people with Burns, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 11 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
mean arterial pressure (time frame: 1 day). The study lists 5 primary outcomes in all. 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 27 Jan 2020.