The Effect of Scheduled Appointments on Family Intensive Care Unit Syndrome in the Intensive Care Units (ICU) of Selected Hospitals of Shahid Beheshti University of Medical Sciences.
Design
Semi-experimental study with control group, with parallel groups, without blinding, randomized, on 80 patients. Even and odd case numbers were used for randomization.
Settings and conduct
In the intervention group, family members are present at the patient's bedside and participate in doing daily tasks, and in the control group. The control group will use the routine rules of the intensive care unit of the hospital for visits.
Participants/Inclusion and exclusion criteria
Inclusion criteria: First-degree relatives of patients؛ Voluntary participation.
Exclusion criteria: Lack of doctor's permission for the participation of family members in care; Unwillingness to participate in the study; Self-reported presence of mental disorders; Lack of alertness and full awareness of place, time, person, as well as the ability to speak; The presence of sensory disorders such as vision or hearing problems affecting learning.
Intervention groups
At the beginning and end of the study, the family syndrome check list and the demographic information form will be filled by both intervention and control groups. Intervention Included presence of the patient's family members outside the meeting time (four 20-minute sessions during a week depending on the situation) to participate in daily life activities such as conversation and participating in moving, feeding and massaging the patient, with the presence of researcher. Control group will use the routine rules of the intensive care unit of the hospital for visits.
Main outcome variables
Family Intensive Care Unit Syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210315050712N1
Registration date:2022-08-19, 1401/05/28
Registration timing:prospective
Last update:2022-08-19, 1401/05/28
Update count:0
Registration date
2022-08-19, 1401/05/28
Registrant information
Name
Maedeh Abedi dorcheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2624 4174
Email address
merciful110@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Scheduled Appointments on Family Intensive Care Unit Syndrome
Public title
The Effect of Scheduled Appointments on Family Intensive Care Unit Syndrome
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Family members of patients hospitalized in the intensive care unit for more than 24 hours
First degree relatives of patients
Absence of self-reported mental disorders
Voluntary participation in the study
Absence of sensory disorders such as vision or hearing problems affecting learning
Exclusion criteria:
Lack of doctor's permission for the participation of family members in care
Unwillingness to participate in the study
Self-reported presence of mental disorders
Lack of alertness and full awareness of place, time, person, as well as the ability to speak
The presence of sensory disorders such as vision or hearing problems affecting learning
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the study is done by simple random method. At first, two hospitals or two general ICU departments that have more beds and the same conditions in terms of equipment and the same rules and restrictions are selected. Among the family members of patients hospitalized in the relevant departments and those who meet the criteria for entering the study, two intervention and control groups will be selected according to the odd and even file number. In this way, patients are identified with an even file number in the control group and an odd number in the intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University
At entering the study (before the intervention), at the end of the first week and at the end of the planned visits.
Method of measurement
The incidence of this syndrome is measured by the score that people get from filling out the syndrome list of the special care patient's family. This list has 31 terms in two dimensions of psychological threat with 17 terms and non-psychological dimension with 14 terms. Scoring on a five-point Likert scale is always (five), usually (four), sometimes (three), rarely (two), never (one). Total scores range from 31 to 155. Based on this, the more points a person gets from the family of the special care patient's syndrome list, the more it will indicate an increase in the special care patient's family syndrome.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before entering the ward, hands are washed according to the instructions and gloves and gowns are worn. In the first meeting with the patient, which will be in the presence of the researcher, according to the doctor's opinion, based on the needs and conditions of the patient and the desire of the family members, participation in daily life activities such as position change and massage will be done. In the next session, depending on the patient's needs, participation in mouthwash or patient nutrition is done in addition to the previous two cares. In the remaining sessions, all contributions will be made depending on the patient's needs. Completing the syndrome list of the patient's family in the intensive care unit is designed in person or by press line and is completed by the research sample (one of the family members). After that, according to the opinion of the visiting person, care training sessions will be arranged and face-to-face in one to two sessions based on the needs of the person, and then a phone number will be provided to them to answer questions.
Category
Prevention
2
Description
Control group: This group will use the routine rules of the intensive care unit of the hospital for visits. Four meetings will be held in accordance with the regulations and restrictions of the department and at the time of the meeting in one week. The control group also receives training related to special care department regulations and meeting hours and compliance with health protocols for special care patients in the form of pamphlets and educational clips. Completing the syndrome list of the patient's family in the intensive care unit is designed in person or by press line and is completed by the research sample (one of the family members). After that, according to the opinion of the visiting person, training sessions will be arranged and face-to-face in one to two sessions based on the needs of the person, and then a phone number will be provided to them to answer questions.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modares and Imam Hossein Hospital
Full name of responsible person
Maedeh Abedi Dorcheh
Street address
No. 35, Unit 3, Kerman St., Mousavi St., Majidieh District, Resalat Highway, Tehran