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IRCT20180930041185N2 IRCT 2019-10-01 National Institute of Medical Research Development (NIMAD) The effects of family-centered affective stimulation on narcotic poisoning comatose patients’ level of consciousness and cortex activity Comparison of the effects of family-centered affective stimulation and sensory stimulation on narcotic poisoning comatose patients’ level of consciousness and cortex activity 2019-10-23 anticipated 90 Complete https://irct.ir/trial/42007 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Other design features: This study was designed to carry out two studies (with the guidance of the principle investigator) with a purely clinical design. In this study, in addition to the design and clinical evaluation of the intervention, the pathway and mechanism of impact on brain cortical activity are also analyzed using EEG. For this reason basic science was chosen. This concurrent characteristic has not been observed in any of the previous studies by the principle investigator or other similar studies in Iran and the world. The project has also been approved and registered at the National Institute for Medical Research Development (NIMAD) No. 983043, Randomization description: Initially, an allocation protocol will developed using the permutated block randomization technique (Pocock, 2013). Then, eligible patients will consecutively recruited and randomly allocated to an experimental, a placebo, or a control group based on the permuted block randomization protocol. Allocation numbers will generated using a table of random numbers, Blinding description: Patients in coma are unaware of the type of intervention and their allocation in the intervention, placebo or control groups. Research colleagues, who record GCS and EEG, are unaware of patients' placement and allocation in study groups. 3 Coma caused by opium poisoning. Intervention 1: Intervention group 1: Intervention 1 in the experimental group: family-centered affective stimulation In the experimental group, a close family member (father, mother, spouse, child, sister, or brother) who had the strongest emotional relationship with the intended patient are selected based on the recommendations of the other members of the family. In parallel, two critical care nurses are provided with training about sensory-affective stimulation, ward rules and regulations, and the importance of family members’ scheduled attendance at their patients’ bedside. In ICU admission, either of these two nurses are provided the intended patient’s close family member with training about family-centered affective stimulation.Training is about the rules and regulations of ICU, patient’s condition, the necessity and importance of scheduled attendance at patient’s bedside, hand washing before entering and after leaving ICU, how to establish the relationship with the patient, and how to provide sensory-affective stimulation. The selected family members attended their patients’ bedside and provided family-centered affective stimulation twice a day (at 11:00 and 15:00) for seven consecutive days (fourteen times in total). The length of each session was 30–45 min.During the sessions, the in-charge nurse of the intended patient accompanied the family member in order to ensure the accurate implementation of the intervention and to help and support the family member. At the first session, either of the two trained nurses provided the intended family member with training about the family-centered affective stimulation program and personally implemented the program.Family-centered affective stimulation consisting of sensory-affective stimulation Family-centered affective stimulation is a sensory-affective stimulation program which consist of four main steps as follows. Auditory stimulation for twenty minutes: In this step, the family member gently will be introduced himself/herself to the patient and will call patient’s name for several times. Then, he/she will provided the patient with information about time and place. After that, he/she are talked with the patient for fifteen minutes about happy daily events in the family, pleasant shared memories, and the health status of family members. Sensory stimulation for ten minutes: The family member firmly will be held the patient’s hands and care his/her face and body.Kinetic stimulation for fifteen minutes: In this step, the family member will be massaged the patient’s hands and legs and are performed passive range-of-motion activities for several times under the in-charge nurse’s supervision. Moreover, he/she will change the patient’s position and massage his/her back with the help of the nurse. Affective conversation: During his/her attendance at the patient’s bedside, the family member are speak with the patient about patient’s interests, enjoyable experiences, and other family members’ health status and interests. Intervention 2: Intervention group 2: Intervention in the placebo group: A fixed trained person who unfamiliar to all patients in the placebo group will be provided them with 30–45 min pure sensory (auditory, tactile, and kinetic) stimulation twice a day for seven consecutive days as follows: introduction (two minutes); providing information about time and place (three minutes); talking about care services, treatments, and patients’ health status compared with previous days (ten minutes); performing nursing measures such as hemodynamic measurements or vital signs assessments (ten minutes); touching patients, moving their extremities, and changing their positions (twenty minutes). Intervention 3: Control group: Intervention in the control group; Patients in the control group are not receive any of the above mentioned sensory or affective stimulation. Rather, they just receive care services and sensory stimulation which routinely will be provided to all patients in the study setting. These services and stimulation include normal lighting of the ICU, noises of the equipment, medication administration, and physical care services such as back and limb massage by nurses, physical therapists, and nurse assistants. These services also will provide to the patients in the placebo and the experimental groups. Patient-family visitation in the control group is also are performed according to the routine of the setting and through the ICU windows. No - There is not a plan to make this available Justification or reason for not sharing IPD is لزومی ندارد در خصوص بخشی از این داده های بصورت داده های دموگرافیک که برای تفسیر یافته ها مهم است در مقاله خواهد آمد.
public Eesa Mohammadi
Nasr Bridge (Gisha); Tarbiat Modares University; Faculty of Medical Sciences
Tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 3550 mohamade@moderes.ac.ir Faculty of Medical Sciences of Tarbiat Modares University scientific Eesa Mohammadi
Nasr Bridge (Gisha), Tarbiat Modares University, Faculty of Medical Sciences
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3550 mohamade@modares.ac.ir Faculty of Medical Sciences of Tarbiat Modares University Iran (Islamic Republic of) Affliction by opium poisoning A Glasgow Coma Scale (GCS) score of 5–8 Age of 18–65 year 18 years 65 years Both Patients who discharged from the ICU Death for any reason Needed an emergency therapeutic intervention Other poisoning in addition to narcotic drugs Stroke or other cerebral events History of CVA and drug abuse Use of psychiatric drugs during the study (S00-T98) injury, poisoning and certain other consequences of external causes Rehabilitation Rehabilitation Rehabilitation Intervention group 1: Intervention 1 in the experimental group: family-centered affective stimulation In the experimental group, a close family member (father, mother, spouse, child, sister, or brother) who had the strongest emotional relationship with the intended patient are selected based on the recommendations of the other members of the family. In parallel, two critical care nurses are provided with training about sensory-affective stimulation, ward rules and regulations, and the importance of family members’ scheduled attendance at their patients’ bedside. In ICU admission, either of these two nurses are provided the intended patient’s close family member with training about family-centered affective stimulation.Training is about the rules and regulations of ICU, patient’s condition, the necessity and importance of scheduled attendance at patient’s bedside, hand washing before entering and after leaving ICU, how to establish the relationship with the patient, and how to provide sensory-affective stimulation. The selected family members attended their patients’ bedside and provided family-centered affective stimulation twice a day (at 11:00 and 15:00) for seven consecutive days (fourteen times in total). The length of each session was 30–45 min.During the sessions, the in-charge nurse of the intended patient accompanied the family member in order to ensure the accurate implementation of the intervention and to help and support the family member. At the first session, either of the two trained nurses provided the intended family member with training about the family-centered affective stimulation program and personally implemented the program.Family-centered affective stimulation consisting of sensory-affective stimulation Family-centered affective stimulation is a sensory-affective stimulation program which consist of four main steps as follows. Auditory stimulation for twenty minutes: In this step, the family member gently will be introduced himself/herself to the patient and will call patient’s name for several times. Then, he/she will provided the patient with information about time and place. After that, he/she are talked with the patient for fifteen minutes about happy daily events in the family, pleasant shared memories, and the health status of family members. Sensory stimulation for ten minutes: The family member firmly will be held the patient’s hands and care his/her face and body.Kinetic stimulation for fifteen minutes: In this step, the family member will be massaged the patient’s hands and legs and are performed passive range-of-motion activities for several times under the in-charge nurse’s supervision. Moreover, he/she will change the patient’s position and massage his/her back with the help of the nurse. Affective conversation: During his/her attendance at the patient’s bedside, the family member are speak with the patient about patient’s interests, enjoyable experiences, and other family members’ health status and interests. Intervention group 2: Intervention in the placebo group: A fixed trained person who unfamiliar to all patients in the placebo group will be provided them with 30–45 min pure sensory (auditory, tactile, and kinetic) stimulation twice a day for seven consecutive days as follows: introduction (two minutes); providing information about time and place (three minutes); talking about care services, treatments, and patients’ health status compared with previous days (ten minutes); performing nursing measures such as hemodynamic measurements or vital signs assessments (ten minutes); touching patients, moving their extremities, and changing their positions (twenty minutes). Control group: Intervention in the control group; Patients in the control group are not receive any of the above mentioned sensory or affective stimulation. Rather, they just receive care services and sensory stimulation which routinely will be provided to all patients in the study setting. These services and stimulation include normal lighting of the ICU, noises of the equipment, medication administration, and physical care services such as back and limb massage by nurses, physical therapists, and nurse assistants. These services also will provide to the patients in the placebo and the experimental groups. Patient-family visitation in the control group is also are performed according to the routine of the setting and through the ICU windows. The score of consciousness level is measured by the GCS scale and patients are selected with a score of 5 to 8. Post-intervention level of consciousness score can range from 3 to 15 which is measured and recorded by the research fellow nurses. Timepoint: Twice a day (morning and evening) up to 7 days. Method of measurement: Before and after intervention by a fellow nurse. Cortical activity recorded by EEG is interpreted and analyzed by a neurologist.EEG signals will be recorded with a digital 26-channel scalp EEG device (g.tec, Guger Technologies, Graz, Austria), using the international 10-20 system. The EEG data will be acquired with a linked ear reference, sampled at 256 Hz with filter between 0.1Hz and 40Hz. Timepoint: Once a day every 7 days. Method of measurement: Every day before and after the intervention (morning shift) every 7 days. National Institute of Medical Research Development (NIMAD) Approved 2019-07-30 این طرح همراه پروپوزال اخلاق پژوهش در موسسه ملی تحقیقات علوم پزشکی (نیماد) تصویب و ثبت گردید. No 21, Besat St., West Fatemi St., Tehran Tehran Iran (Islamic Republic of)