NCT02623686

Brief Summary

It is known from the literature that patients in the Intensive Care Unit do not get enough sleep impacting on short and longterm recovery (Tembo \& Parker, 2009; Bihari et al, 2012; Kamdar et al, 2012). The use of non-pharmacological interventions such as massage with essential oils is supported by the literature as being useful in encouraging sleep (Richards et al, 2003; Matthews, 2011). Over 30% of cancer patients are accessing complementary therapies such as these (Rees et al, 2000; Lewith et al, 2002). We propose investigating whether aromatherapy massage and the use of essential oils in the form of an Inhalation Patch (Bioesse TM) prove to be a useful intervention for improving patient sleep whilst on the critical care unit.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

December 3, 2015

Last Update Submit

December 7, 2015

Conditions

Sleep Deprivation

Keywords

SleepICUMassage TherapyInhalation Patch

Outcome Measures

Primary Outcomes (1)

  • • Differences in RCSQ patient scores

    24 months

Secondary Outcomes (1)

  • • Difference in BIS scores

    24 months

Study Arms (2)

Aroma group

EXPERIMENTAL

* two massages delivered within a two day period * the patient will choose the essential oils used from blend A and blend B (if no choice is made, therapist will choose blend A and B alternately). One drop of the essential oil blend will be added to 5 mls of grapeseed base oil. * an Inhalation Patch with the same blend of oils as used in the massage will be left by the therapist for use on each of the two nights following the aromatherapy massage intervention. Its use will be explained to the patient and to the member of nursing staff. The Inhalation Patch will be applied to the patient's upper chest when it is time to sleep at approximately 11 pm and will be removed the following morning at approximately 6 am.

Other: Aroma Therapy Massage and Inhalation Patch

Control Group

NO INTERVENTION

Normal Care

Interventions

Aroma Therapy Massage and Inhalation PatchOTHER
Aroma group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • any NHS patient with cancer admitted to the CCU during the period of the study
  • aged 18 years or over
  • who wishes to take part in the study

You may not qualify if:

  • expected length of stay \< 4 days
  • habitual use of sleep medication more than 3 times per week
  • no sleep meds/hypnotics allowed during study period
  • no sedation during intervention period (propofol; clonidine; midazolam)
  • extensive brain metastases/hypoxic or traumatic brain injury
  • sleep apnoea
  • excessive alcohol consumption \>50 units/week (ascertained via notes)
  • extensive wound/skin damage that precludes massage (e.g. drug-related bullae/skin desquamation)
  • neuromuscular blockade
  • any normal massage contraindications including: severe respiratory or hemodynamic instability, GCS \<7\*, ICP \<20\* mmHg, no contraindication for changing in body position (including active significant bleeding etc)
  • allergies to the use of essential oils, either on the skin or inhaled, precluding the use of both of the study blends
  • allergy to base (grapeseed) oil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 8, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations

GB(1)