The aim of this experiment is to determine the effect of nurse follow up care on burn patients' health. Design of study is RCT with control and intervention groups. Sampling will be purposive and based on inclusion criteria. Random allocation of subjects to control and intervention groups will be based on block randomization at discharge time. So that 6 block of size 4 will be prepared: AABB, ABAB, ABBA, BBAA, BABA, BAAB. Then these blocks will be arranged randomly and subjects will be allocated to two groups based on A and B. This will be repeated continuously. Sample size will be 90 (45 for intervention and 45 for control groups). Intervention group will receive the follow up care (home visit and telephone follow up). If any kind of problem recognizes, the patient will be referred to specialists (surgeon, psychologist, physiotherapist...). Also they will receive education and for prevention of contracture, goniometry will be done for them and ROM exercise will be educated. Control group will receive routine care in burn unit. The duration of follow up care is 6 months. Both control and intervention groups will be assessed at discharge time, 1.5, 3 and 6 months later. At sixth month the health status of both groups will be assessed and compared.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016110630712N2
Registration date:2017-04-14, 1396/01/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-14, 1396/01/25
Registrant information
Name
Nastaran Heydarikhayat
Name of organization / entity
Shahid Beheshti University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
heydarikh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of nurse's follow up care on burn patients' health
Public title
The impact of nurse's follow up care on health status of burn patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age>18 years; severity of burn > 15%; second and third degree burn; orientation to person, place and time for answering to questions.
Exclusion criteria :
No willing to continue the study; past history of admission to burn centers; history of visual and hearing disorder or mental retardation; history of depression and schizophrenia.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Shahid Arabi Avenue, ٰYemen Avenue, Shahid Chamran highway, Tehran
City
Tehran
Postal code
Approval date
2015-11-03, 1394/08/12
Ethics committee reference number
SBMU2.REC.1394.168
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T20-T32
ICD-10 code description
Incl.: burns (thermal) from: electrical heating appliances electricity flame friction hot air and hot gases hot objects lightning radiation chemical burns [corrosions] (external)(internal) scalds Excl.: erythema [dermatitis] ab igne (L59.0) radiation-rela
Primary outcomes
1
Description
Health status
Timepoint
3th and 6th month after discharge
Method of measurement
Burn Specific Health Scale, brief- The Persian version of this tool has 40 questions and 8 dimensions. Dimensions describe patients performance such as sensitivity to heat, hand’s performance and simple abilities, therapeutic regimes, labor, sexual functioning, interpersonal relationships, emotion and body image. Items will be scored based on a 5- degree likert, 0 (severly) to 4 (no/ not at all) and higher scores mean higher performance and quality of life.
Secondary outcomes
1
Description
Psychological Assessment
Timepoint
Discharge time, 1.5, 3 and 6 months after discharge
Method of measurement
General Health Questionnaire 28 (GHQ-28)
2
Description
Pain
Timepoint
Discharge time, 1.5, 3 and 6 months after discharge
Method of measurement
Brief Pain Inventory
3
Description
Pruritus/ Itching
Timepoint
Discharge time, 1.5, 3 and 6 months after discharge
Method of measurement
VAS
4
Description
Scar
Timepoint
Discharge time, 1.5, 3 and 6 months after discharge
Method of measurement
VSS: Vancouver Scar Scale
5
Description
Range Of Motion: ROM
Timepoint
Discharge time, 1.5, 3 and 6 months after discharge
Method of measurement
Goniometry
Intervention groups
1
Description
Intervention group: 1. Oral or written education or education by telephone about wound care, skin graft, donor care. 2-home visit at least 3 times or based on patients' needs. 3-phone call based on patients' needs. The number of phone calls are more during first weeks after discharge from hospital and decrease gradually. 4. goniometery and determination the range of motion and refer to surgeon and physiotherapist if needed.5-problem detection and refer to specialists.
Category
Other
2
Description
Control group: routine of hospital care that always deliver by nurses and doctors.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Kermanshah
Full name of responsible person
Nastaran Heydarikhayat
Street address
Imam Khomeini Hospital, Naghlieh Ave, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences، Shahid Arabi Avenue, ٰYemen Avenue, Shahid Chamran highway, Tehran
City
Tehran
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 of Shahid Beheshti 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
Shahid Beheshti University of Medical Scinces
Full name of responsible person
Nastaran Heydarikhayat
Position
PhD student in nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Shahid Beheshti University of Medical Scinces, Vali Asr street, Niayesh Cross Road, Niayesh highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
heydarikh@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical sciences
Full name of responsible person
Nastaran Heydarikhayat
Position
PhD student in nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Shahid Beheshti University of Medical Scinces, Vali Asr street, Niayesh Cross Road, Niayesh highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
heydarikh@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nastaran Heydarikhayat
Position
PhD student in nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Shahid Beheshti University of Medical Scinces, Vali Asr street, Niayesh Cross Road, Niayesh highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
heydarikh@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)