NCT00624637

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 27, 2008

Status Verified

February 1, 2008

Enrollment Period

1.9 years

First QC Date

February 15, 2008

Last Update Submit

February 25, 2008

Conditions

Distress

Keywords

aromatherapymassagecomfortpostoperativeinfantscraniofacial surgery

Outcome Measures

Primary Outcomes (1)

  • level of COMFORT with videotaped COMFORT behavior scale

    first 24 hours postoperative

Secondary Outcomes (1)

  • 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

Study Arms (3)

A

OTHER

infants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively

Other: aromatherapy massage

B

OTHER

infants after craniofacial surgery receive one massage with carrier oil three hours postoperatively

Other: aromatherapy massage

C

NO INTERVENTION

no intervention, standard postoperative care

Interventions

aromatherapy massageOTHER

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

Also known as: A - aromatherapy massage, B - massage
AB

Eligibility Criteria

Age6 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Neurological impairment
  • Eczema or other skin disorders
  • Nut allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Surgical Intensive Care, Erasmus MC-Sophia

Rotterdam, South Holland, 3000 CB, Netherlands

RECRUITING

Related Publications (1)

  • de Jong M, Lucas C, Bredero H, van Adrichem L, Tibboel D, van Dijk M. Does postoperative 'M' technique massage with or without mandarin oil reduce infants' distress after major craniofacial surgery? J Adv Nurs. 2012 Aug;68(8):1748-57. doi: 10.1111/j.1365-2648.2011.05861.x. Epub 2011 Nov 3.

    PMID: 22050553DERIVED

Study Officials

  • Dick Tibboel, prof, MD

    Erasmus MC-Sophia

    STUDY DIRECTOR

Central Study Contacts

Marjan de Jong, RN

CONTACT

4636151m.dejong.3@erasmusmc.nl

Monique van Dijk, Dr

CONTACT

4636066m.vandijk.3@erasmusmc.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 27, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 27, 2008

Record last verified: 2008-02

Locations

NL(1)