Effectiveness of Inhalation Aromatherapy In Children With Burns
Primary Purpose
Burns
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inhalation aromatherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Burns focused on measuring pediatric, aromatherapy
Eligibility Criteria
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
-
Sites / Locations
- Dr. Behcet Uz Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Lavender 15
Lavender 60
Jojoba
Arm Description
Participant who inhalates lavender oil for 15 minutes.
Participant who inhalates lavender oil for 60 minutes.
Participant who inhalates jojoba oil for 15 minutes.
Outcomes
Primary Outcome Measures
mean arterial pressure
The mean arterial pressure of the child was evaluated and recorded before dressing, also 1 and 30 minutes after the dressing.
body temperature
The body temperature of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
heart rate
The heart rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
respiratory rate
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
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".
Secondary Outcome Measures
Full Information
NCT ID
NCT04237285
First Posted
January 14, 2020
Last Updated
January 23, 2020
Sponsor
Izmir Katip Celebi University
Collaborators
Dr. Behcet Uz Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04237285
Brief Title
Effectiveness of Inhalation Aromatherapy In Children With Burns
Official Title
Effectiveness of Inhalation Aromatherapy In Children With Burns: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University
Collaborators
Dr. Behcet Uz Children's Hospital
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
pediatric, aromatherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lavender 15
Arm Type
Experimental
Arm Description
Participant who inhalates lavender oil for 15 minutes.
Arm Title
Lavender 60
Arm Type
Experimental
Arm Description
Participant who inhalates lavender oil for 60 minutes.
Arm Title
Jojoba
Arm Type
Placebo Comparator
Arm Description
Participant who inhalates jojoba oil for 15 minutes.
Intervention Type
Other
Intervention Name(s)
Inhalation aromatherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
mean arterial pressure
Description
The mean arterial pressure of the child was evaluated and recorded before dressing, also 1 and 30 minutes after the dressing.
Time Frame
1 day
Title
body temperature
Description
The body temperature of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
Time Frame
1 day
Title
heart rate
Description
The heart rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
Time Frame
1 day
Title
respiratory rate
Description
The respiratory rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
Time Frame
1 day
Title
FLACC Pain Scale Scores
Description
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".
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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,
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.
Exclusion Criteria:
-
Facility Information:
Facility Name
Dr. Behcet Uz Children's Hospital
City
İzmir
ZIP/Postal Code
35640
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Inhalation Aromatherapy In Children With Burns
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