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IRCT2016062622772N3 IRCT 2016-09-20 Vice Chancellor for research of Zabol University of Medical Science Effect of Massage With Mint Essential Oil on Level of Consciousness and Vital Signs in Patients with Brain Damages 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 2016-03-10 anticipated 38 Complete https://irct.ir/trial/19569 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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. N/A Traumatic brain injuries. Intervention 1: 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). Intervention 2: 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).
public Abdolghani Abdollahimohammad
Ferdowsi ST,Nursing and Midwifery School
Zabol Iran (Islamic Republic of) 9861663335 +54 32230770 s.taheri338@gmail.com Zabol University of Medical Sciences scientific Mohammad Reza Firouzkouhi
Ferdowsi ST, nursing and midwifery school
Zabol Iran (Islamic Republic of) 9861663335 +98 54 3223 0770 m.firouzkohi@yahoo.com Zabol University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 40 years Both SO6.0, SO6 Intracranial injury Treatment - Other Placebo 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). 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). 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. 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. 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. 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. 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. 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. Vice Chancellor for research of Zabol University of Medical Science Approved 2016-03-09 Ethics committee of Zabol University of Medical Science Shahid Rajae st-Research and technology Deputy of Zabol University of Medical science Zabol Iran (Islamic Republic of)