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IRCT20111203008286N9 IRCT 2021-01-05 Tehran University of Medical Sciences The effect of interactive communication application on satisfaction and anxiety of intubated patients admitted to intensive care units The effect of interactive communication application on satisfaction and anxiety of intubated patients admitted to intensive care units 2021-05-22 anticipated 54 Complete https://irct.ir/trial/52958 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Designing an application by the researcher that can be installed on mobile phones to facilitate communication of intubated patients hospitalized in intensive care unit, Randomization description: Sampling will be done from the Available samples. Randomized block with quadruple blocks will be used for division of participants. The assignment of the groups will be done by someone out of the study and the investigator won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it, Blinding description: The assignment of the groups will be done by someone out of the study and the investigator won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it. N/A communication of intubated patients. Intervention 1: Intervention group: Alert Intubated patients in intensive care unit that use the application designed by the researcher to communicate with nurses. The target population includes conscious intubated patients admitted to the intensive care units of hospitals affiliated to Qom University of Medical Sciences. The researcher refers to the intensive care units and enrolls patients with inclusion criteria. Sampling will be done from the Available samples. Randomized block with quadruple blocks will be used for division of participants. The assignment of the groups will be done by someone out of the study and the investigator won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it. In the control and intervention group, after obtaining informed consent and completion of HARS questionnaire and researcher-made communication satisfaction questionnaire, eligible patients will be included in the study. In the control group, the nurse will communicate with the patient via the routine communication methods( According to an initial field study in intensive care units affiliated to Qom University of Medical Sciences , the only way to communicate is with the help of yes-no questions and lip-reading) and in the intervention group the desired application will be installed on the nurse's phone and the patient will communicate with the nurse via this application when then need arises. The nurse will use this application every time he/she communicates with the patient and he/she will be required to use this application for the communication during every shift. On fourth day of the study, the mentioned questionnaires will be completed again by the researcher by asking the questions of the questionnaire from the patient without additional explanation about the items. It will be coordinated with the head- nurse how the patients participated in groups will be divided for the nurse so that one nurse does not care for two patients at the same time in the intervention and control groups. Intervention 2: Control group: Alert Intubated patients in intensive care unit that use the routine methods of communication like yes/no question and lip reading, for communicating with nurses. 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 There is no more information
public Mohadese Samimi
Nursing & Midwifery School, East Nosrat st., Tohid sq
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 silvermoon8916@gmail.com Tehran University of Medical Sciences scientific Fatemeh Bahramnezhad
Nursing & Midwifery School, East Nosrat st., Tohid sq.
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 bahramnezhad.f@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Desire for participating in the study age 18-60 years old Orientation to time, person and place Reading, writing and seeing Ability first experience of hospitalization in Intensive Care unit 24 hours after intubation 18 years 60 years Both Hearing, tactile, visual disorders Receiving sedatives, narcotics, benzodiazepines and barbiturates N/A N/A Intervention group: Alert Intubated patients in intensive care unit that use the application designed by the researcher to communicate with nurses. The target population includes conscious intubated patients admitted to the intensive care units of hospitals affiliated to Qom University of Medical Sciences. The researcher refers to the intensive care units and enrolls patients with inclusion criteria. Sampling will be done from the Available samples. Randomized block with quadruple blocks will be used for division of participants. The assignment of the groups will be done by someone out of the study and the investigator won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it. In the control and intervention group, after obtaining informed consent and completion of HARS questionnaire and researcher-made communication satisfaction questionnaire, eligible patients will be included in the study. In the control group, the nurse will communicate with the patient via the routine communication methods( According to an initial field study in intensive care units affiliated to Qom University of Medical Sciences , the only way to communicate is with the help of yes-no questions and lip-reading) and in the intervention group the desired application will be installed on the nurse's phone and the patient will communicate with the nurse via this application when then need arises. The nurse will use this application every time he/she communicates with the patient and he/she will be required to use this application for the communication during every shift. On fourth day of the study, the mentioned questionnaires will be completed again by the researcher by asking the questions of the questionnaire from the patient without additional explanation about the items. It will be coordinated with the head- nurse how the patients participated in groups will be divided for the nurse so that one nurse does not care for two patients at the same time in the intervention and control groups. Control group: Alert Intubated patients in intensive care unit that use the routine methods of communication like yes/no question and lip reading, for communicating with nurses Anxiety score in Hamilton Anxiety Rating Scale(HARS). Timepoint: Before starting the intervention and 4 days after intervention. Method of measurement: Hamilton Anxiety Rating Scale(HARS). Satisfaction score in Researcher-made questionnaire. Timepoint: Before starting the intervention and 4 days after intervention. Method of measurement: Researcher-made questionnaire. Tehran University of Medical Sciences Approved 2020-11-10 Ethics committee of School of Nursing and Midwifery and School of Rehabilitation, Tehran University Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)