Protocol summary

Summary
(1) Objectives: Determine the effect of artificial airway non-verbal communication on patient satisfaction with artificial airway in the hospitals in Shiraz city in 1394; Determining the demographic characteristics of patients with artificial airway; Determining and comparing patient satisfaction with artificial airway before and after the intervention to separate in the experimental and control groups; Compare the change in the mean patient satisfaction of patients with artificial airway before and after the intervention in the experimental group and the control groups. (2) Design: Random sampling; Placing the samples in both groups was one among; Communication boards were used as the intervention in the experimental group; Control group with no intervention; A multi-center project. (3) How do: Sampling in intensive care units of health centers of Shiraz University of Medical Sciences is done; Placing in the experimental and the control groups is in Odd method; The study population is all patients with artificial airway in hospitals in Shiraz city; samples were 50 patients; Intervention done by a trained nurses under periodic surveillance of researcher for 12 hours and then the satisfaction questionnaire will be available to the patients. (4) Participants: Inclusion criteria included artificial airway for at least 18 hours; GCS of 11; Having read and write. Exclusion criteria included the patient's unwillingness to participate in the study. (5) Interventions: communication boards contain numbers; letters; pictures and words will be shown to the patient by a nurse every 4 hours, then patient, referring her/his requires on the board to notify the nurse and the questionnaire will be complete according to the patient. (6) The main outcome variables: non-verbal communication, satisfaction, education level, marital status, occupation, monthly income, age and gender.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112122466N4
Registration date: 2016-08-27, 1395/06/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-27, 1395/06/06
Registrant information
Name
Shahnaz Pouladi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 374 0061
Email address
sh.pooladi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Bushehr University of Medical Science.
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-06-30, 1395/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the Influence of nonverbal communication method on satisfaction of patients with artificial airway in medical centers in Shiraz in 1394.
Public title
Assessment of the Influence of nonverbal communication method on satisfaction of patients with artificial airway in medical centers in Shiraz in 1394
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for this study include mastered in Persian; Age over 18 years; Having artificial airway for at least 18 hours; The ability to understand and work orders; In other words patients with GCS=11 and There is no audio imperfections. Exclusion criteria include patients' reluctance to participate in the study.
Age
From 18 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics committee of Bushehr University of Medical Science
Street address
Pardis site, Bushehr University of Medical Science, Sabzabad, Bushehr.
City
Bushehr
Postal code
7518759577
Approval date
2015-10-19, 1394/07/27
Ethics committee reference number
bpums.rec.1394.22

Health conditions studied

1

Description of health condition studied
Respiratory disease
ICD-10 code
J38
ICD-10 code description
Paralysis of vocal cords and larynx

Primary outcomes

1

Description
Satisfaction
Timepoint
Befor intervention and 12 hours after intervention
Method of measurement
Satisfaction Questionnaire

2

Description
Nonverbal communication
Timepoint
Befor intervention and 12 hours after intervention
Method of measurement
Satisfaction Questionnaire

Secondary outcomes

1

Description
Unsatisfaction
Timepoint
12 hours after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
the intervention tool is a communication board, including numbers, letters, words and images that are used for12 hours for groups. nurses show this communication board to patients every 4 hours and for 12 hours and ask the patients to meet their needs on the board and show them with hand, to facilitate their communication.
Category
Rehabilitation

2

Description
Nurses care control group with usual non-verbal communication way, such as lip-read, using pen and paper.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Nemazi teaching hospital
Full name of responsible person
Parvin Salehi- Nursing Graduate Student
Street address
Nemazi square- Zand Blvd- Shiraz- Iran
City
Shiraz

2

Recruitment center
Name of recruitment center
Shiraz trauma center
Full name of responsible person
Parvin Salehi- Nursing Graduate Student
Street address
Chamran Blvd- Shiraz-Iran
City
Shiraz

3

Recruitment center
Name of recruitment center
Martyr Faghihi Hospital
Full name of responsible person
Parvin Salehi- Nursing Graduate Student
Street address
Zand Blvd- Shiraz- Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,bushehr university of medical science
Full name of responsible person
Dr. Afshin Ostovar
Street address
First floor, Pardis Site, Salman Farsi Ave, Bahmany, Bushehr
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,bushehr university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Bushehr university of medical science
Full name of responsible person
Shahnaz Pouladi
Position
PHD, Assitant professor of nursing
Other areas of specialty/work
Street address
Pardis site, Salman Farsi Ave, Bahmany,Bushehr
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Fax
+98 77 3345 2228
Email
Research(AT) Bpums.ac.ir; Sh.pooladi@bpums.ac.ir
Web page address
www.bpums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr university of medical science
Full name of responsible person
Shahnaz Pouladi
Position
PHD- Assisstant professor of nursing
Other areas of specialty/work
Street address
Pardise Site, Salman Farsi Avenue, Bahmany, Bushehr.
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Fax
+98 77 3345 2228
Email
Research(AT) Bpums.ac.ir; Sh.pooladi@bpums.ac.ir
Web page address
www.bpums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bushehr university of medical science
Full name of responsible person
Shahnaz Pouladi
Position
PHD-Assistant professor of nursing
Other areas of specialty/work
Street address
Pardis Site, Salman Farsi Ave, Bahmany, Bushehr.
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Fax
+98 77 3345 2228
Email
Research(AT) Bpums.ac.ir; Sh.pooladi@bpums.ac.ir
Web page address
www.bpums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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