Effectiveness of Inhalation Aromatherapy In Children With Burns

NCT04237285 | Completed

• 1 other identifier: 2018/201
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

pediatric; aromatherapy

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Lavender 15

EXPERIMENTAL

Participant who inhalates lavender oil for 15 minutes.

Other: Inhalation aromatherapy

Lavender 60

EXPERIMENTAL

Participant who inhalates lavender oil for 60 minutes.

Other: Inhalation aromatherapy

Jojoba

PLACEBO COMPARATOR

Participant who inhalates jojoba oil for 15 minutes.

Other: Inhalation aromatherapy

Interventions

Inhalation aromatherapy OTHER

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.

Jojoba; Lavender 15; Lavender 60

Eligibility Criteria

• Age: 2 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Dr. Behcet Uz Children's Hospital: collaborator

Study Sites (1)

Dr. Behcet Uz Children's Hospital

Izmir, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 23, 2020
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)