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Does massage with or without essential oils enhance relaxation in hospitalized children with burn injuries in South Africa?

Massage with our without aromatherapy in children with burns: A randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27056
Enrollment
300
Registered
2013-03-30
Start date
2013-04-03
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pediatric burn patients, massage with carrier oil, aromatherapy massage, essential oils

Interventions

Two massage interventions will be compared to control condition. One includes massage with grapeseed oil only. The other, the aromatherapy massage condition will be performed with essential oils in gr

Sponsors

Red Cross War Memorial Children's Hospital Cape Town, South Africa
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Burns greater 19%, burns of face, hands, feet, genitalia, perineum and major joints, electrical and chemical burns, inhalation injury, circumferential burns; 2. Patients are admitted to the burns unit of the Red Cross War Memorial Children's Hospital in Cape Town.

Exclusion criteria

Exclusion criteria: 1. Patients whose parents do not give informed consent for the study and patients > 11 years who are not willing to participate; 2. Patients who are considered not to respond well to massage due to the type of trauma (intentional injury); 3. Burn area too large and not enough unburned or healed skin available; 4. Children being prepared for theatre or just having returned from theatre; 5. Children already sleeping; 6. Older children saying they did not want treatment; 7. Younger children – especially toddlers – who show extreme fear when strangers approach them; 8. Children who have not yet been stabilized.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the mean difference between before and after massage behavioral scores from videotaped material assessed by a researcher who is blind for treatment allocation. Assessment instruments: 1. Muscle Tension Inventory: The Muscle Tension Inventory (MTI) has been validated by Tan et al. (2010) in burn patients aged 8 to 71 years of age.(Tan, Yowler et al. 2010) The MTI evaluates muscle tension of each of 8 body areas (forehead, eyes, facial expression, mouth/jaw, head/neck, chest, arms, legs) on a scale from 1 (relaxed) to 5 (tense) giving a total score between 8 to 40; 2. Behavioral Relaxation Scale: The Behavioral Relaxation Scale (BRS) has been validated in adults and children (Schilling and Poppen 1983; Raymer and Poppen 1985; Norton, Holm et al. 1997). It consists of a description of 10 postures or behaviors characteristic of a fully relaxed person: 1) breathing – scored as relaxed if less than the baseline rate; 2) quiet – no vocalizations; 3) body – no movement of the trunk; 4) head in midline; 5) eyes – closed with smooth eyelids; 6) jaw – lips parted in center; 7) throat – no movement; 8) shoulders – sloped and even, no movement; 9) hands – curled in ‘claw like’ position; 10) feet – pointed away from each other forming an approximate 90° angle. The total score ranges from 0 (totally relaxed) to 50 (totally not relaxed) with lower scores indicating greater relaxation; 3. COMFORT behavior scale: The COMFORT behavior scale (van Dijk, de Boer et al. 2000; Ista, van Dijk et al. 2005) has been validated in children between 0-to-3 years of age. It consists of six items: 1. Alertness; 2. Calmness; 3. Respiratory response (for ventilated children) or Crying (for spontaneously breathing children); 4. Body movements; 5. Facial tension; and 6. Muscle tone. Each item has five response alternatives rated 1 to 5 representing the different intensities of the behavior in question. Summating the six ratings leads to a total score, theoretically ranging

Secondary

MeasureTime frame
The secondary outcome will be change in oxygen saturation and heart rate between before and after massage/control condition. A handheld pediatric Pulse Oximeter (Clinical Guard®, OctiveTech 300AH) will be used to record heart rate and oxygen saturation.

Contacts

Public ContactM. Tabak

Roessinghsbleekweg 33b

m.tabak@rrd.nl+31 (0)53 4875777

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)