Does Massage With or Without Aromatherapy Reduce Infant's Distress?

Distress Clinical Trial

— aromatherapy  

Official title:

Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00624637
• Other study ID #: 2007-253
• Status: Unknown status
• Phase: Phase 4
• First received: February 15, 2008
• Last updated: February 25, 2008
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2008
• Source: Erasmus Medical Center
• Contact: Marjan de Jong, RN
• Phone: 4636151
• Email: m.dejong.3[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine the effect of massage with or without aromatherapy on infant´s level of distress

Description:

Despite extensive use of pharmacological treatments such as sedatives, distress and anxiety remain a huge problem in patients admitted to the PICU, especially in the 65% under the age of 3. Parents are anxious about the outcome and feel powerless because they have to transfer care to doctors and nurses. Those in favor of complementary care, realize at the same time that there is lack of evidence to support its use in daily practice. On the other hand, many sedatives used in infants are unlicensed and animal studies even suggest increased risk of neuroapoptosis using midazolam at an early age.

In a first study we will evaluate the effects of aromatherapy massage or massage compared to standard care in infants after craniofacial surgery.

The first group receives: aromatherapy massage using a concentration of mandarin essence in the massage oil, the second group: massage (without essential oils) and the third (control) group receives standard postoperative care. Massage will be performed in a standardized way using the ' m' technique® developed by dr. Buckle. Primary outcome is the percentage of patients with COMFORT behavior score below 17, assessed from videomaterial by a rater blinded for condition.The intervention will be carried out three hours after return from surgery.Secondary outcomes are bedside COMFORT behavior scores assessed by the caregiving nurse and the amount of midazolam used in the first 24 hours postoperative as well as the use of additional analgesics such as paracetamol and morphine.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 110
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

Inclusion Criteria:

• Infants aged 6 to 36 months admitted to the Intensive Care-Sophia after craniofacial surgery

Exclusion Criteria:

• Neurological impairment

• Eczema or other skin disorders

• Nut allergy

Related Conditions & MeSH terms

• Distress

Intervention

Other:
• aromatherapy massage
Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only

Locations

Country	Name	City	State
Netherlands	Pediatric Surgical Intensive Care, Erasmus MC-Sophia	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of COMFORT with videotaped COMFORT behavior scale		first 24 hours postoperative
Secondary	COMFORT behavior bedside and Visual Analogue Scale distress, change in Heart Rate, change in Mean Arterial Pressure, amount of required sedatives/opioids		first 24 hours postoperative