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IRCT20111210008359N3 IRCT 2023-09-05 Tabriz University of Medical Sciences The effect of scheduled visit of family caregivers on incidence and severity of delirium among patients admitted in ICU and their caregivers anxiety Comparison of the Effectiveness of Scheduled Visits of Family Caregivers on incidence and severity of Delirium among Patients admitted to ICU and their caregivers' anxiety 2023-09-23 anticipated 40 Complete https://irct.ir/trial/72171 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The participants will be 40 male and female conscious patients hospitalized in Intensive care units and will be selected through convenience sampling. At the beginning of each work shift, the researcher will be informed about the availability of beds and the possible admission of new patients by visiting in person or by calling the officials of the special departments. The participants in the groups will be assigned to the intervention and control groups using the random block method with 4 and 6 blocks and with a ratio of 1:1. Stratification will be done based on the sampling location (Imam Reza, Sinai and Razi Hospital). In order to hide the allocation, the type of allocation will be written on paper and placed in opaque envelopes that are numbered consecutively (Allocation Concealment). The envelopes will be opened in order and by a person not involved in sampling. If the participant is included in the intervention group, a member of the patient's family who meets the family caregiver entry criteria will be selected as the patient's main caregiver to participate in the intervention. Then, the communication protocol and meeting schedule will be taught face-to-face and in writing to the family caregivers of the intervention group. N/A delirium. Intervention 1: Intervention group: After determining the main caregiver, the objectives and method of the study are explained to them. Then, in a briefing session, the necessary training is provided regarding how to perform the intervention, and then the materials are given to them in the form of a booklet. After the coordination of the researcher with the patient's nurse and the shift manager, the family caregivers of the patients are present at the patient's bedside for 15 minutes from 16:00 to 17:00 and from 21:00 to 22:00 and communicate with the patient according to the defined protocol. During the entire duration of the meeting, the researcher is a non-participant observer of the meeting and examines the caregiver's performance during the meeting. If necessary, after the completion of the intervention, training will be given to the caregiver again so that the method of implementing the intervention can be modified in the next meeting. Also, before the presence of the caregiver at the patient's bedside, immediately after leaving the patient's bedside, 60, 120, and 180 minutes after the presence of the caregiver, the patient is checked with the NeeCham scale in terms of the incidence and severity of delirium. Intervention 2: Control group: meeting in this group is done according to routine meetings. The researcher was present at the patient's bedside at the appointed time for the visit and immediately before and after the presence of the caregiver, 60, 120 and 180 minutes after the presence of the caregiver, as in the intervention group, examines the patient with the NeeCham scale in terms of the incidence and severity of delirium. . 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 further information.
public Farnaz Rrahmani
Sought shariate street, Tabriz nursing and midwifery school, Tabriz University of Medical Sciences, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 1479 6770 frahmani@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Farnaz Rrahmani
Sought shariate street, Tabriz nursing and midwifery school, Tabriz University of Medical Sciencesو, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 frahmani@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Conscious patients with Glasgow Coma Index score <13 Willingness and consent to participate in the study Patients who are not completely isolated No delirium and cognitive disorders in the patient before entering the study Not taking anti-anxiety drugs at the time of starting the intervention by the caregiver 18 years 80 years Both Unavailability of primary caregiver F05 Delirium due to known physiological condition N/A N/A Intervention group: After determining the main caregiver, the objectives and method of the study are explained to them. Then, in a briefing session, the necessary training is provided regarding how to perform the intervention, and then the materials are given to them in the form of a booklet. After the coordination of the researcher with the patient's nurse and the shift manager, the family caregivers of the patients are present at the patient's bedside for 15 minutes from 16:00 to 17:00 and from 21:00 to 22:00 and communicate with the patient according to the defined protocol. During the entire duration of the meeting, the researcher is a non-participant observer of the meeting and examines the caregiver's performance during the meeting. If necessary, after the completion of the intervention, training will be given to the caregiver again so that the method of implementing the intervention can be modified in the next meeting. Also, before the presence of the caregiver at the patient's bedside, immediately after leaving the patient's bedside, 60, 120, and 180 minutes after the presence of the caregiver, the patient is checked with the NeeCham scale in terms of the incidence and severity of delirium. Control group: meeting in this group is done according to routine meetings. The researcher was present at the patient's bedside at the appointed time for the visit and immediately before and after the presence of the caregiver, 60, 120 and 180 minutes after the presence of the caregiver, as in the intervention group, examines the patient with the NeeCham scale in terms of the incidence and severity of delirium. . Incidence and severity of Delirium. Timepoint: Before the intervention, 60, 120 and 180 minutes after the intervention for 5 consecutive days. Method of measurement: The Neelon and Champagne Confusion Scale(NeeCham). Anxiety score of the main caregiver. Timepoint: The first day before the intervention, the fifth day after the intervention. Method of measurement: Speilberger State – Trait Anxiety Inventory (STAI). Tabriz University of Medical Sciences Approved 2023-08-07 Ethics Committee of Tabriz University of Medical Sciences, Vice chancellor for research Sought shariatee street, Tabriz nursing and midwifery school, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)