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IRCT2016120831299N1 IRCT 2017-02-04 Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences Sensory stimulation in Stroke comatose patients The effect of organized sensory stimulation program on coma recovery and disease outcomes in comatose stroke patients 2017-01-08 anticipated 80 Complete https://irct.ir/trial/24660 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. 2 Stroke. Intervention 1: intervention group: Implication of sensory stimulation program include of auditory, visual, olfactory, gustatory, tactile and kinesthetic stimulation. At first select the stimulus according to the patients favourite through families interview and then develop the list of stimulus that should be used in sensory stimulation program. Auditory stimulation will be performed with verbal communication, tape recording of family member voices and patient favorite music. Visual stimulation will be performed with penlight, photographs of family members and mirror. In the beginning of the visual stimulation, the researcher had to hold the patients’ eyes open to vision. Olfactory stimulation will be performed with patients’ favorite aromas such as perfume, orange or lemon, coffee, vanilla,.. Gustatory stimulation will be performed with irrigation of the oral cavity with cool water, gum massage, brushing of the teeth and then lemon juice will be applied to the lateral side of tongue. Tactile stimulation will be performed with warm and cold water, applying wet towels and then the patient’s arms, hands, trunk, and legs will be massaged with olive oil. Finally kinesthetic stimulation will be performed. Intervention 2: In the control group will not be performed any intervention except routine care.
public Khadijeh Sargolzaei
School of Nursing and Midwifary, Ibn Sina St, Doctora Intersection, Daneshgah Avenue
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 sargolzaeikh2@mums.ac.ir Mashhad University of Medical Sciences, School of Nursing and Midwifary scientific Dr Nahid Aghebati
School of Nursing and Midwifary, Ibn Sina St, Doctora Intersection, Daneshgah Avenue
Mahhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 aghebatiz@mums.ac.ir Shool of Nursing and Midwifary Iran (Islamic Republic of) Inclusion Criteria: age between 35 to 75 years; duration of coma more than 72 hours and less than 14 days; GCS between 6 and 12; the availability of one of the patient's family who is over 18 years; family consent of the patient to participate in the study; Iranian citizenship and fluent in Persian; lack of vision problems and blindness; no hearing problems; the absence of psychotic mental illness; the lack of skin problems; the lack of sedative and narcotic Exclusion Criteria: metabolic disorders; drug addiction; get sedatives and drugs during the study; the prohibition in mobility organs; sensory-motor disorder in four limbs; patients who have suffered from a stroke in the areas of visual and auditory nerves; identification of vision problems; hearing problems; skin diseases and psychological problems during the study; sudden hemodynamic disorder that can cause critical situations for patients; died before the fourteenth days 35 years 75 years Both G45, G46 Transient cerebral ischaemic attacks and related syndromes,Vascular syndromes of brain in cerebrovascular diseases Other Other intervention group: Implication of sensory stimulation program include of auditory, visual, olfactory, gustatory, tactile and kinesthetic stimulation. At first select the stimulus according to the patients favourite through families interview and then develop the list of stimulus that should be used in sensory stimulation program. Auditory stimulation will be performed with verbal communication, tape recording of family member voices and patient favorite music. Visual stimulation will be performed with penlight, photographs of family members and mirror. In the beginning of the visual stimulation, the researcher had to hold the patients’ eyes open to vision. Olfactory stimulation will be performed with patients’ favorite aromas such as perfume, orange or lemon, coffee, vanilla,.. Gustatory stimulation will be performed with irrigation of the oral cavity with cool water, gum massage, brushing of the teeth and then lemon juice will be applied to the lateral side of tongue. Tactile stimulation will be performed with warm and cold water, applying wet towels and then the patient’s arms, hands, trunk, and legs will be massaged with olive oil. Finally kinesthetic stimulation will be performed. In the control group will not be performed any intervention except routine care Coma recovery. Timepoint: before and after of intervention for 14 consecutive days. Method of measurement: CRS-R. Sensory function. Timepoint: before and after of intervention for 14 consecutive days. Method of measurement: SMART. Cognitive function. Timepoint: before and after of intervention for 14 consecutive days. Method of measurement: RLA. The severiety of stroke. Timepoint: before intervention at first day, seventh and fourtheen days after intervention. Method of measurement: NIHSS. HemodynamicCriteria:PR,RR,BP,SPo2. Timepoint: before and after intervention for 14 consecutive days. Method of measurement: Cardiopulmonary monitoring and Sphygmomanometer. - - Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences Approved 2016-05-28 Ethics committee of Mashhad University of Medical Sciences Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Next to the Hoveyzeh Cinema, Daneshgah Avenue Mashhad Iran (Islamic Republic of)