Clinical trial NCT04237285: 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
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: pediatric
aromatherapy
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Dr. Behcet Uz Children's Hospital
First posted: 2020-01-23
Enrollment: 108
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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:

-

Primary outcomes:
measure: mean arterial pressure
timeFrame: 1 day
measure: body temperature
timeFrame: 1 day
measure: heart rate
timeFrame: 1 day
measure: respiratory rate
timeFrame: 1 day
measure: FLACC Pain Scale Scores
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dr. Behcet Uz Children's Hospital
Study officials:
References: