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The effects of family presence on pain and pain anxiety dressing of patient in burn intensive care unit in zare hospital

Protocol summary

Summary
The aim of this Randomized Clinical Trial is to determine the effect of family attendance on pain and anxiety arising from the pain of dressing change of patients from intensive care ward in ZARE HOSPITAL of SARI.Inclusion Criteria: All patients over 18 years old, alert, burn more than 10% Grade 2 and 3 with moderate and severe burns.Exclusion Criteria: Drug Addiction, A History of Severe Mental Illness, Mental Retardation and Cognitive, Respiratory Distress, Intubated, Infection of the Wound, Transfer, Discharge and Death. Sample: 110 Patients are in two groups each (n = 55) based on random assignment experimental and control groups. On third day of admission, participants (preferably relative) in the event of dont having severe anxiety entered in the study. Then, training includes the patient's condition, the provisions of section, treatment of patients with wound dehiscence, infection control precautions including hand washing, entry requirements and duration of the clinical evaluation of the patient's manipulation of joints, participation in nutrition as primary care offered by the researcher. In the intervention group, from fourth day of hospitalization, a family member for 5 consecutive days in one-hour meetings and before dressing will be present at bedside of the patient. Control group (without mobile) will be treated. Anxiety and pain caused by burns after pain and 15 minutes before dressing, and intensity immediately before and after dressing for 6 consecutive days (3rd to 8th days) in the two groups will be discussed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201602297494N17
Registration date: 2016-05-18, 1395/02/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-18, 1395/02/29
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2016-03-05, 1394/12/15
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of family presence on pain and pain anxiety dressing of patient in burn intensive care unit in zare hospital
Public title
The effects of family presence on pain and pain anxiety dressing of patient in burn intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: All patients over 18 years old, alert, burn more than 10% Grade 2 and 3 with moderate and severe burns.Exclusion Criteria: Drug Addiction, A History of Severe Mental Illness, Mental Retardation and Cognitive, Respiratory Distress, Intubated, Infection of the Wound, Transfer, Discharge and Death.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
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
Mazandaran University of Medical Sciences
Street address
Start of valiye asr highway, Imam Square, Sari, Mazandaran
City
sari
Postal code
4736131167
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
IR.MAZUMS.REC.94-2126

Health conditions studied

1

Description of health condition studied
Burns and corrosions
ICD-10 code
T20-T32
ICD-10 code description
Burns and corrosions

Primary outcomes

1

Description
Burn pain anxiety
Timepoint
15 minutes before dressing change from the third to the eighth hospitalization day
Method of measurement
Burn specific Pain Anxiety Scale

2

Description
Pain
Timepoint
Immediately before and after dressing change from the third to the eighth hospitalization day
Method of measurement
Visual Analog scale

Secondary outcomes

empty

Intervention groups

1

Description
The one-hour-presence of the patient's desired attendant at bedside for five consecutive days before dressing by observing train cases from 4th to 8th hospitalization day.
Category
Other

2

Description
The absence of attendant in a control group with will perform.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zare Hospital
Full name of responsible person
Masoomeh Koohi
Street address
Zare Hospital,sari
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr.Ahmadali Enayati
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran.
City
Sari
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 Mazandaran University of Medical Sciences.
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
Mazandaran University of Medical Sciences
Full name of responsible person
Masoomeh Koohi
Position
MSC in Critical Care Nursing
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, , Sari
City
Sari
Postal code
48197-53171
Phone
+98 11 3336 7342
Fax
Email
m.koohi61@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masoumeh Bagheri Nesami
Position
PHD in nursing/ faculty member
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Sari, Mazandaran
City
Sari
Postal code
Phone
+98 11 3336 7342
Fax
+98 15 1226 8915
Email
anna30432003@yahoo.com
Web page address

Person responsible for updating data

Contact

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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