Effect of Aromatherapy Massage With Mint Essential Oil on Level of Consciousness and Physiological Parameters of Patients
with Traumatic Brain Injuries at Intensive Care Units
The present study aimed to evaluate the effect of aromatherapy massage with mint essential oil on the level of consciousness and physiological parameters in patients with traumatic brain injuries.The study population included all patients admitted with a diagnosis of brain injury,Inclusion criteria: 8 to 12 level of consciousness based on non-response overview scale (FOUR); aged 18-40 years; hemodynamic stability; the absence of sensory disorders in patients. The sample consisted of 38 patients. Targeted sampling method was used to select eligible individuals by taking into account inclusive and exclusive criteria. The selected individuals were randomly assigned to control(19) and experimental(19) groups. In the experimental group, the patients underwent 20 minutes of massages on hands and feet with 4% diluted mint and sweet almond essential oils for three consecutive days. Nonaromatic oil massage was performed in the control group using the same techniques and procedures carried out in the intervention group. Expected outcomes include changes in the level of consciousness after the intervention and changes in physiological variables, including: HR, RR, o2 SAT and systolic and diastolic blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062622772N3
Registration date:2016-09-20, 1395/06/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-20, 1395/06/30
Registrant information
Name
Abbas Balouchi
Name of organization / entity
Zabol University of Medical science
Country
Iran (Islamic Republic of)
Phone
+98 54 3222 1271
Email address
a.baluchi@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Cancellor for research of Zabol University of Medical Sciences
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aromatherapy Massage With Mint Essential Oil on Level of Consciousness and Physiological Parameters of Patients
with Traumatic Brain Injuries at Intensive Care Units
Public title
Effect of Massage With Mint Essential Oil on Level of Consciousness and Vital Signs in Patients with Brain Damages
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : 8 to 12 level of consciousness based on non-response overview scale (FOUR); less than six-month and more than 48-hour hospitalization; minimum age of 18 and maximum age of 40; no history of chronic disease (diabetes, cardiovascular disease, epilepsy and renal disease) and endocrine disorders (Cushing's syndrome and hypo/hyperthyroid); no history of sensory-nervous disorders, coma or previous head injury; no evidence of increased intracranial pressure (ICP) and symptoms of fat embolism; no evidence of drug addiction; absence of ulcers, inflammation, infection, skin diseases and fractures in the areas undergoing massage.
Exclusion criteria: Transfer patients to other health centers; Deterioration of the patient's condition and the need for cardiopulmonary resuscitation.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random sample assignment:
Initially to create a random sequence, the coin toss method was used. In a manner that one of the study groups is considered tails and the other heads, the coin toss is repeated as many times as the sample volume (38 patients) and each member of group is assigned a random coin toss.
Then to conceal any trace of random assignment, and to avoid any prediction of future assignment by researchers and participants, with respect to study’s sample volume, a number of aluminum foiled envelopes (so that the contents are not visible) are readied and each of random sequences are recorded on a card, then the cards are put into the envelopes in order. To keep the random sequence the envelopes are also numbered in the same order. Finally the envelopes are sealed and put into boxes in order. At the registration, for each of participants who are eligible to enter the study, an envelope is opened in order of their entrance and their assigned group is revealed.
The creation of random sequence and assignment concealment is performed by a non-researcher and a researcher who is not aware of sample conditions.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zabol University of Medical Science
Street address
Shahid Rajae st-Research and technology Deputy of Zabol University of Medical science
City
Zabol
Postal code
9861663335
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
zbmu.1.REC.1394.130
Health conditions studied
1
Description of health condition studied
Traumatic brain injuries
ICD-10 code
SO6.0, SO6
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
Systolic Blood Pressure
Timepoint
Immediately before intervention and within 5 minute after intervention then at 1,2,3 and 4 hours after intervention.
Method of measurement
Monitoring devices
2
Description
Diastolic Blood Pressure
Timepoint
Immediately before intervention and within 5 minute after intervention then at 1,2,3 and 4 hours after intervention.
Method of measurement
Monitoring devices
3
Description
Heart Rate
Timepoint
Immediately before intervention and within 5 minute after intervention then at 1,2,3 and 4 hours after intervention.
Method of measurement
Monitoring devices, pulse oximetry
4
Description
Respiratory rate
Timepoint
Immediately before intervention and within 5 minute after intervention then at 1,2,3 and 4 hours after intervention.
Method of measurement
Observation chest in a minute
5
Description
Arterial Oxygen Saturation
Timepoint
Immediately before intervention and within 5 minute after intervention then at 1,2,3 and 4 hours after intervention.
Method of measurement
Monitoring devices, pulse oximetry
Secondary outcomes
1
Description
Level of consciousness
Timepoint
Immediately before intervention and within 5 minute after intervention then at 1,2,3 and 4 hours after intervention.
Method of measurement
FOUR scale
Intervention groups
1
Description
Experimental group: Aromatherapy massage with mint oil.Prior to intervention, the author warmed up his hands. Then, he spread 4% diluted mint oil and sweet almond oil on his hands and he rubbed the patients’ hands from wrist to fingers and feet from ankles to toes with stroking movements. The massage was carried out as pressuring with the entire palm. Intervention lasted for 20 minutes for three consecutive days (10-minute hand massage and 10-minute foot massage).
Category
Treatment - Other
2
Description
Control group: Nonaromatic oil massage. Prior to intervention, the author warmed up his hands. Then, he spread sweet almond oil on his hands and he rubbed the patients’ hands from wrist to fingers and feet from ankles to toes with stroking movements. The massage was carried out as pressuring with the entire palm. Intervention lasted for 20 minutes for three consecutive days (10-minute hand massage and 10-minute foot massage).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-AL-momenin hospital
Full name of responsible person
Safiyeh Taheri
Street address
beginning of the road of Zabol-Zahedan
City
Zabol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Zabol University of Medical Science
Full name of responsible person
Zahra Speheri
Street address
Shahid rajaie ST- Research Deputy of Zabol University of Medical Science
City
Zabol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Zabol University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Abdolghani Abdollahimohammad
Position
PhD of Nursing
Other areas of specialty/work
Street address
Ferdowsi ST,Nursing and Midwifery School
City
Zabol
Postal code
9861663335
Phone
+54 32230770
Fax
+98 51 5422 9952
Email
s.taheri338@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mohammad Reza Firouzkouhi
Position
PhD of Nursing
Other areas of specialty/work
Street address
Ferdowsi ST, nursing and midwifery school
City
Zabol
Postal code
9861663335
Phone
+98 54 3223 0770
Fax
+98 51 5422 9952
Email
m.firouzkohi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Safiyeh Taheri
Position
Post Graduate Student
Other areas of specialty/work
Street address
Ferdowsi ST, Nursing and Midwifery School
City
Zabol
Postal code
9561167391
Phone
+98 51 5435 3380
Fax
+98 51 5422 9952
Email
s.taheri338@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)