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

February 25, 2008 updated by: Erasmus Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3000 CB
        • Recruiting
        • Pediatric Surgical Intensive Care, Erasmus MC-Sophia
        • Principal Investigator:
          • Marjan de Jong, RN
        • Sub-Investigator:
          • Monique van Dijk, Dr
        • Principal Investigator:
          • Dick Tibboel, Prof, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
infants after craniofacial surgery receive one massage with aromatherapy three hours postoperatively
Other: aromatherapy massage
Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only
Other Names:
  • A - aromatherapy massage
  • B - massage
Other: B
infants after craniofacial surgery receive one massage with carrier oil three hours postoperatively
Other: aromatherapy massage
Ten minutes massage of hands, arms or feet with mandarin essential oil 1% (Citrus reticulata) or with carrier oil only
Other Names:
  • A - aromatherapy massage
  • B - massage
No Intervention: C
no intervention, standard postoperative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
level of COMFORT with videotaped COMFORT behavior scale
Time Frame: first 24 hours postoperative
first 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
COMFORT behavior bedside and Visual Analogue Scale distress, change in Heart Rate, change in Mean Arterial Pressure, amount of required sedatives/opioids
Time Frame: first 24 hours postoperative
first 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Study Director: Dick Tibboel, prof, MD, Erasmus MC-Sophia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

February 27, 2008

Study Record Updates

Last Update Posted (Estimate)

February 27, 2008

Last Update Submitted That Met QC Criteria

February 25, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2007-253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Distress

Clinical Trials on aromatherapy massage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe