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The effect of rehabilitation nursing intervention model on the comprehensive health and daily performance of patients with hand burns

Protocol summary

Study aim
Evaluating the effect of rehabilitation nursing intervention model on the comprehensive health and daily performance of patients with hand burns
Design
A clinical trial with a control group, with parallel groups, randomized postoperative care, and outcome assessment on 60 patients. The method of allocating samples in groups is in the form of four random blocks without permutation. The lottery method was used for the randomization of blocks.
Settings and conduct
This study is performed in Shahid Motahari Burns Hospital in Tehran, affiliated to Iran University of Medical Sciences. Patients are divided into experimental and control groups by four random blocks without permutation.
Participants/Inclusion and exclusion criteria
Inclusion criteria; hand burns, Age over 18 years, No history of mental illness, Interested to participate in the study, Being literate. Exclusion criteria: Serious damage to upper limbs muscles, tendons, skeletons and nerves, Patients with severe heart disease who were unconscious before the burn, Patients with heart, lung and brain diseases, Unwillingness to participate the study.
Intervention groups
Intervention group: Receiving rehabilitation nursing model in 3 steps: 1- Acute stage: social support, health education, psychological counseling and passive hand movements. 2- Recovery stage: psychological counseling, intellectual-emotional therapy and active hand exercises. 3- Post-discharge stage: Conversation about re-employment and intellectual-emotional support. The control group receives routine nursing care.
Main outcome variables
The quality of life in patients with hand burn

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201207049634N1
Registration date: 2021-11-28, 1400/09/07
Registration timing: registered_while_recruiting

Last update: 2021-11-28, 1400/09/07
Update count: 0
Registration date
2021-11-28, 1400/09/07
Registrant information
Name
Mahnaz Seyedoshohadaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
saydshohadai@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rehabilitation nursing intervention model on the comprehensive health and daily performance of patients with hand burns
Public title
The effect of rehabilitation nursing intervention on the health of patients with hand burns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
hand burns Deep burns Age over 18 years No history of mental illness Interested to participate in the study Being literate
Exclusion criteria:
Serious damage to the muscles of the upper limbs, tendons, skeletons and nerves Patients with severe heart disease who were unconscious before the burn Patients with heart, lung, and brain diseases Unwillingness to participate in the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of allocating samples in groups is in the form of four random blocks without permutation. The letter A for the control group and the letter B are considered for the test group. Different modes of two groups (ABBA-BABA-ABAB-BAAB-BBAA-AABB) are written on six cards. Each card is placed in a sealed envelope. These envelopes are placed in a box and the researcher does not know in which group the research units will be located until the card is selected. A person who is not aware of the study and the groups, by selecting one of the envelopes from the box, determines in which group the patients will be located. This process is continued until all six cards are taken out of the box and the cards are returned to the box and this random selection is repeated to provide the desired sample size.
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 Iran University of Medical Sciences
Street address
Faculty of Nursing and Midwifery of Iran University of Medical Sciences, Rashid Yasemi St., above Mirdamad, Vali Asr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19967-13883
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IR.IUMS.REC.1399.715

Health conditions studied

1

Description of health condition studied
Hand burns
ICD-10 code
M61.34
ICD-10 code description
Calcification and ossification of muscles associated with burns, hand

Primary outcomes

1

Description
The quality of life in patients with hand burn
Timepoint
At the time of admission, recovery and post discharge from the hospital
Method of measurement
Quality of life questionnaire for burn patients: This questionnaire includes 40 questions in the areas of skin sensitivity to heat, body image, hand function, how to care for burned areas, job-communication, ability to perform simple activities, sexual function and emotional dimension and It has a 5-point Likert scale (severe, high, medium, low and not at all) that scaled from one to five and each question has the minimum score of 1 and the maximum of 5 . Out of 40 questionnaire questions, 18 questions are related to the physical dimension of quality of life, 11 questions are related to the psychological dimension of quality of life and 11 questions are related to the social dimension of quality of life. The quality of life is assessed for each dimension separately and also in all dimensions. The quality of life is based on the scores' average, the higher the mean, the better the quality of life and the lower mean represents lower quality of life.

2

Description
Activities of Daily Living
Timepoint
At the time of admission; recovery: the first four weeks (once a week); post discharge from the hospital: six months post discharge (once a month)
Method of measurement
The Lawton Instrumental Activities of Daily Living Scale (IADL)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in the intervention group, in addition to routine hospital treatment-rehabilitation programs, receive a rehabilitation nursing model in 3 stages: 1- Acute stage: social support, health education, psychological counseling and passive hand movements. 2- Recovery stage: psychological counseling, treatment. Rational-emotional and active hand exercises. 3- Post-discharge stage: 1- Talk about re-employment and intellectual-emotional support.
Category
Rehabilitation

2

Description
Control group: Patients in the control group receive only routine nursing care for 5 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Burns Hospital
Full name of responsible person
Mahnaz Seyedoshohadaee
Street address
Shahid Motahari Burns Hospital, Rashid Yasemi st., Valiasr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19967-13883
Phone
+98 21 8877 0031
Email
seyedoshohadaee.m@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motevalian
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8670 2504
Email
motevalian.a@iums.ac.ir
Web page address
https://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Seyedoshohadaee
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Iran University of Medical Sciences, Rashid yasemi St., above Mirdamad, Vali Asr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19967-13883
Phone
+98 21 8888 2885
Email
seyedoshohadaee.m@iums.ac.ir
Web page address
https://fnm.iums.ac.ir/fa?sid=31

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Seyedoshohadaee
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Iran University of Medical Sciences, Rashid yasemi St., above Mirdamad, Vali Asr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19967-13883
Phone
+98 21 8888 2885
Email
seyedoshohadaee.m@iums.ac.ir
Web page address
https://fnm.iums.ac.ir/fa?sid=31

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahnaz Seyedoshohadaee
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Iran University of Medical Sciences, Rashid yasemi St., above Mirdamad, Vali Asr St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19967-13883
Phone
+98 21 8888 2885
Email
seyedoshohadaee.m@iums.ac.ir
Web page address
https://fnm.iums.ac.ir/fa?sid=31

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data on the primary outcome is for sharing
When the data will become available and for how long
One year after the publication the data will be available.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Meta-analysis is allowed on the data of this study.
From where data/document is obtainable
Ms,Mahnaz Seyedoshohadaee, Faculty of Nursing and Midwifery of Iran University of Medical Sciences, Rashid yasemi St., above Mirdamad, Vali Asr St., Tehran, Iran , Email: seyedoshohadaee.m@iums.ac.ir
What processes are involved for a request to access data/document
After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email.
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