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IRCT20151107024919N12 IRCT 2020-11-01 Kerman University of Medical Sciences The effect of aromatherapy massage with Mint and sweet almond oil on physiological parameters and sleep quality of traumatic brain injury patients Investigation of aromatherapy massage with Mint and sweet almond oil effects on physiological parameters and sleep quality of traumatic brain injury patients admitted in intensive care units 2020-11-21 anticipated 60 Complete https://irct.ir/trial/51408 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to assign the participants to the intervention and control groups, block allocation is used. In this method, 4 blocks are used, in each block there are two people in the intervention group and two people in the control group. R software is used for random block allocation, Blinding description: Blindness in this study is single blind, so that the statistician is not aware of the study groups. N/A Condition 1: physiological parameters. Condition 2: sleep quality. Intervention 1: Intervention group: In the intervention group, hands and feet will be massaged with mint oil(Noorhan Company) mixed with sweet almond(Noorhan Company) oil for 20 minutes. The intervention will be performed for 20 minutes for three consecutive days (ten minutes of hand massage and 10 minutes of foot massage with each hand and each foot for 5 minutes). Prior to the intervention, physiological parameter forms (including blood pressure, arterial blood oxygen saturation, heart rate, and respiration) and sleep quality questionnaire will be completed. The researcher will warm his hands. Then, he will spread 5 teaspoons of mint oil mixed with sweet almond oil on his hands. He will then rub the patient's hands from the wrists to the fingers and toes from the ankles to the toes with caressing movements. The massage will be done with pressure with the palm of the hand. In the first stage of foot massage, each groove between the tendons that connect the ankle to the toes will be slightly pressed using the thumb or other toe. In the second stage, the feet and heels will be massaged. In the third step, the toes will be pulled back and forth separately. In the fourth step, the thumb and another finger of the massager will be pulled on the toes in an outward direction (from the base to the tips of the toes). The hand massage will be done on both the palm and the back of the hand. In the first stage, pressure and movements from the wrist to the fingers will be performed with direct pressure and moderate intensity. In the second stage, a semicircular stretch from the center of the hand to the surroundings will be performed with medium pressure. In the third step, small circular motions around the arm will be performed with gentle pressure. The palm will then be massaged. Information on physiological parameters will be recorded five minutes after the intervention and every hour for four hours after the intervention. The intervention will be repeated for three consecutive days in each group. On the morning of the fourth day, after the intervention, the sleep quality questionnaire will be completed again. Intervention 2: Control group: In the control group, massage with Vaseline(kanz brand)will be performed using the same techniques and methods as in the intervention group, and the same amount of oil used for the intervention group will be weighed and we will use Vaseline in proportion to the weight of the oil. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The researcher doesn't have any interest to share because of ethical issues. ( there​ is No further information)
public Batool Tirgari
Kerman University of Medical Sciences, Medical University Campus, Haft- Bagh- Alavi Highway, Kerman
kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 b_tirgari@kmu.ac.ir Kerman University of Medical Sciences scientific Batool Tirgari
Kerman University of Medical Sciences, Medical University Campus, Haft- Bagh- Alavi Highway, Kerman
kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 b_tirgari@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Level of consciousness according to the Glasgow Coma scale 12-15 Less than six months and more than 48 hours of hospitalization Patient age in the range of 15 to 65 years 15 years 65 years Both A sudden drop in the level of consciousness Transfer to another hospital Discharge before the fourth day Death of patients in both intervention and control groups during the study At the same time, the patient participates in similar care programs such as massage therapy History of chronic disease (diabetes, cardiovascular disease, epilepsy and kidney disease) and endocrine disorders (Cushing's syndrome and hypo / hyperthyroidism) A history of sensorineural disorders, coma, or previous head injury Evidence of increased intracranial pressure (ICP) and symptoms of fat embolism Wounds, inflammation, infection, skin diseases and fractures in the massage areas Other Placebo Intervention group: In the intervention group, hands and feet will be massaged with mint oil(Noorhan Company) mixed with sweet almond(Noorhan Company) oil for 20 minutes. The intervention will be performed for 20 minutes for three consecutive days (ten minutes of hand massage and 10 minutes of foot massage with each hand and each foot for 5 minutes). Prior to the intervention, physiological parameter forms (including blood pressure, arterial blood oxygen saturation, heart rate, and respiration) and sleep quality questionnaire will be completed. The researcher will warm his hands. Then, he will spread 5 teaspoons of mint oil mixed with sweet almond oil on his hands. He will then rub the patient's hands from the wrists to the fingers and toes from the ankles to the toes with caressing movements. The massage will be done with pressure with the palm of the hand. In the first stage of foot massage, each groove between the tendons that connect the ankle to the toes will be slightly pressed using the thumb or other toe. In the second stage, the feet and heels will be massaged. In the third step, the toes will be pulled back and forth separately. In the fourth step, the thumb and another finger of the massager will be pulled on the toes in an outward direction (from the base to the tips of the toes). The hand massage will be done on both the palm and the back of the hand. In the first stage, pressure and movements from the wrist to the fingers will be performed with direct pressure and moderate intensity. In the second stage, a semicircular stretch from the center of the hand to the surroundings will be performed with medium pressure. In the third step, small circular motions around the arm will be performed with gentle pressure. The palm will then be massaged. Information on physiological parameters will be recorded five minutes after the intervention and every hour for four hours after the intervention. The intervention will be repeated for three consecutive days in each group. On the morning of the fourth day, after the intervention, the sleep quality questionnaire will be completed again. Control group: In the control group, massage with Vaseline(kanz brand)will be performed using the same techniques and methods as in the intervention group, and the same amount of oil used for the intervention group will be weighed and we will use Vaseline in proportion to the weight of the oil. Heart rate. Timepoint: Heart rate will be measured before intervention, 5 minutes after intervention, one hour after intervention, 2 hours after intervention, 3 hours after intervention, 4 hours after intervention and for three consecutive days. Method of measurement: Monitoring device. Systolic blood pressure. Timepoint: Systolic blood pressure will be measured before intervention, 5 minutes after intervention, one hour after intervention, 2 hours after intervention, 3 hours after intervention, 4 hours after intervention and for three consecutive days. Method of measurement: Monitoring device. Diastolic blood pressure. Timepoint: diastolic blood pressure will be measured before intervention, 5 minutes after intervention, one hour after intervention, 2 hours after intervention, 3 hours after intervention, 4 hours after intervention and for three consecutive days. Method of measurement: Monitoring device. Respiratory rate. Timepoint: Breathing will be measured before intervention, 5 minutes after intervention, one hour after intervention, 2 hours after intervention, 3 hours after intervention, 4 hours after intervention and for three consecutive days. Method of measurement: Observed by the researcher. Arterial blood oxygen saturation. Timepoint: Arterial blood oxygen saturation will be measured before intervention, 5 minutes after intervention, one hour after intervention, 2 hours after intervention, 3 hours after intervention, 4 hours after intervention and for three consecutive days. Method of measurement: Monitoring device. Sleep quality. Timepoint: Sleep quality will be measured before the intervention and the fourth day. Method of measurement: Richard Campbell sleep questionnaire. Kerman University of Medical Sciences Approved 2020-10-20 Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran kerman Kerman Iran (Islamic Republic of)