Effectiveness of Inhalation Aromatherapy In Children With Burns

Burns Clinical Trial

Official title:

Effectiveness of Inhalation Aromatherapy In Children With Burns: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237285
• Other study ID #: 2018/201
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2020
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 7 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Burns

Intervention

Other:
• Inhalation aromatherapy
Besides routine care, the Control Group was treated with jojoba oil (Simmondsia Chinensis- produced by Arifoglu, 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 Arifoglu, 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.

Locations

Country	Name	City	State
Turkey	Dr. Behcet Uz Children's Hospital	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Katip Celebi University	Dr. Behcet Uz Children's Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean arterial pressure	The mean arterial pressure of the child was evaluated and recorded before dressing, also 1 and 30 minutes after the dressing.	1 day
Primary	body temperature	The body temperature of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.	1 day
Primary	heart rate	The heart rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.	1 day
Primary	respiratory rate	The respiratory rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.	1 day
Primary	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".	1 day