Protocol summary

Summary
The purpose of this study is to determine the effect of self-care education on quality of life for patients with hip replacements is this study is non-randomized clinical trial with a control group. The members of this research are 60 people to detailed replacement surgery in Hazrat Rasoul Akram and Shafa Yahyaian Educational Treatment Center for the first time that this surgery , and in the absence of training sessions in one will be excluded. Study participants randomly based on hospital visit will be in interventional and control groups. First, the demographic questionnaire by the participants before the study is completed. Then, the patients in the intervention group under self-care education using the form of lecture, role playing and question and answer using pre-prepared manual training manual for 5 sessions of 45-30 minutes.The quality of life questionnaire SF - 36 was completed by the patients at the day of clearance from hospital and eight weeks after clearance. After the intervention, to respect ethical training manual will be placed at the disposal of the control group and the test questionnaire by descriptive and inferential statistical analysis will.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016042727629N1
Registration date: 2016-06-18, 1395/03/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-18, 1395/03/29
Registrant information
Name
Seyedkazem Moosavi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 919 466 7497
Email address
kazemmoosavi69@gmail.com
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery, Iran University of Medical Sciences
Expected recruitment start date
2016-05-30, 1395/03/10
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
The effect of self-care education on quality of life for patients with hip joint replacement
Public title
The effect of self-care education on quality of life in patients with hip joint replacement
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the ability to understand and speak Persian؛ have at least read and write؛ age less than 75 years؛ the absence of visual and auditory sensory disorders, especially؛not cancer or other organic disorders (dementia, stroke) or disorders severe psychological؛ clients that are operated for the first time؛ no restrictions on the movements of the upper extremities؛ the accompaniment of the primary caregiver in the educational process Exclusion criteria: Opt out of the study؛ The absence in more than one training session؛ Create an undesirable complication after surgery or the patient died during the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
Iran University of Medical Sciences, Between The Highway Martyr Chamran and Martyr Sheikh Fazlullah Nuri, Martyr Hemmat Highway ,Tehran, Iran.
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.IUMS.REC.1394 .9211196237

Health conditions studied

1

Description of health condition studied
Total hip replacement
ICD-10 code
Z96.6
ICD-10 code description
Presence of orthopaedic joint implants

Primary outcomes

1

Description
Quality of life
Timepoint
2 months after intervention
Method of measurement
SF-36 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In this study, the intervention program consisted of 5 in the form of lecture, role playing and question and answer using pre-prepared manual.Training manual, based on training the patient, using library study, and enjoyment of nursing teachers, one of the orthopedic surgeons, physiotherapists, a nutritionist and expert ulcer produced the first session of the training program the client will take place and to study the topics of each session, before the start of the training session will be emphasized. During the training sessions, research, patient and answer questions and discuss questions and ambiguities will encourage and at the end of each session, the patient will be asked to repeat and practice skills and in subsequent meetings, for role in the training class. In the first session, the investigator after their introduction, description of the training program and the purpose of the intervention and the importance of collaboration will represent the client as well as the anatomy of the hip joint, the need for joint replacement, joint replacement benefits and limitations, types of joint replacement and self-importance and necessity will be described. In the second session, about the possible complications after hip replacement surgery will be discussed. Each of the possible complications of surgery, including infection, implant dislocation, deep venous thrombosis and embolism, nerve damage and limb explained inequalities and ways to prevent and minimize them fully described. The third session will be dedicated to mobility and activities after surgery.will be discussed. In the fourth session, on wound care will be discussed. Time of dressing change, the sterile wound dressing change, signs of possible infection, drugs, the drugs and possible side effects will be explained fully. Finally, the fifth session of the Diet, prevent constipation, prevention of bedsores and admission to the clinic, as well as warning signs for an immediate visit to the doctor, will be discussed. It should be noted that all training sessions will be planned and implemented after the surgery.
Category
Other

2

Description
The control group was not given education and training routine by researchers that included educational pamphlets will receive
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-e-Akram Hospital
Full name of responsible person
Mehri Bozorgnejad
Street address
Iran School of Nursing and Midwifery,Yasami St., Vali Asr Avenue.
City
Tehran

2

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Mehri Bozorgnejad
Street address
Iran School of Nursing and Midwifery,Yasami St., Vali Asr Avenue.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Assistance of Iran University of Medical Sciences
Full name of responsible person
Syed Ali Javad Mousavi
Street address
Iran University of Medical Sciences, Between The Highway Martyr Chamran and Martyr Sheikh Fazlullah Nuri, Martyr Hemmat Highway ,Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistance of Iran 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
Iran School of Nursing and Midwifery, Iran Universityof Medical Science
Full name of responsible person
Mehri Mozorgnejad
Position
MSc
Other areas of specialty/work
Street address
Iran School of Nursing and Midwifery , Yasami St., Vali asr Avenue.
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
mbozorgnejad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran School of Nursing and Midwifery, Iran University of Medical Science
Full name of responsible person
Mehri Bozorgnejad
Position
MSc
Other areas of specialty/work
Street address
Iran School of Nursing and Midwifery , Yasami St., Vali asr Avenue
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
mbozorgnejad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran School of Nursing and Midwifery, Iran Universityof Medical Science
Full name of responsible person
Seyedkazem Moosavi
Position
M.Sc. Nursing Student
Other areas of specialty/work
Street address
Iran School of Nursing and Midwifery , Yasami St., Vali asr Avenue
City
Postal code
Phone
00
Fax
Email
Web page address

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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