Aims: This study aimed to investigate the effect of continuing care on patient quality of life after disc surgery in Neurosurgery and VIP ward in Alzahra hospital in Isfahan, Iran, in 2013. Materials and methods: This study is a clinical trial conducted on 64 patients hospitalized for herniation disk surgery. The patients were selected by simple sampling method and were randomly assigned to two groups (study and control), 32 person in each group. The continuing care programs carry out for 3 month. Including criteria were age 18-65 year, full consciousness, and candidate for disk surgery in first time, and excluding criteria were, psychological disorders and participant in a complementary program. Patients response to Short Form(SF-36)questionnaire before, and 6 weeks and 3 month after continuing care in study group ,and simultaneously, in control group. Primary outcome was dimensions of quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071213039N3
Registration date:2015-08-06, 1394/05/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Hojatollah Yousefi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7543
Email address
yousefi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2013-08-24, 1392/06/02
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuing care on patient quality of life after Lumbar disc surgery
Public title
The effect of continuing care on patient after disc surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Including criteria:
age 18-65 year;
full consciousness;
candidate for disk surgery in first time;
excluding criteria:
psychological disorders;
participant in a complementary program.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
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 Isfahan University of Medical Sciences
Street address
Azadi Square, Hezar-Jerib Street, Isfahan University of Medical Sciences, Isfahan. Postal cod: 81746-73461
City
Isfahan
Postal code
Approval date
2013-11-20, 1392/08/29
Ethics committee reference number
392473
Health conditions studied
1
Description of health condition studied
lumbar herniation disk
ICD-10 code
G55.1
ICD-10 code description
Nerve root and plexus compressions in intervertebral disc disorders
Primary outcomes
1
Description
Quality of life
Timepoint
before,and 6 weeks and 3 month after intervention
Method of measurement
SF36 Quality of Life questionnare
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: continuous care after surgery to 3 months,
and exercise therapy for 2 weeks from 4th to 6th weeks after surgery
Category
Treatment - Surgery
2
Description
Control Group: 2 educational sessions about caring after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Units, Al-Zahra Hospital,
Full name of responsible person
Manijeh Eslami
Street address
Sofe Blv.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Neamatbakhsh
Street address
Azadi Square, Hezar-Jerib street, Isfahan University of Medical Sciences, Isfahan. Postal cod: 81746-73461
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Manijeh Eslami
Position
Staff of Neurosurgery Ward
Other areas of specialty/work
Street address
Sofe Blv. Al Zahra Hospital, Isfahan. Postal cod: 81746-75731
City
Isfahan
Postal code
8174675731
Phone
+98 31 3625 5555
Fax
+98 31 3669 1510
Email
yousefi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Yousefi Hojatollah
Position
PhD
Other areas of specialty/work
Street address
Azadi Square, Hezar Jerib Ave., Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan. Postal cod: 81746-73461
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 7543
Fax
+98 31 3669 9398
Email
yousefi@nm.mui.ac.ir
Web page address
www.nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hojatollah Yousefi
Position
PhD in Nursing/ Academic member
Other areas of specialty/work
Street address
Hezarjerib Av., Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 7543
Fax
+98 36699398
Email
yousefi@nm.mui.ac.ir
Web page address
www.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)