This study is a randomized clinical trial in order to evaluate the effect of specific care programs in the field of activity and resting on anxiety and quality of life of patients with abdominal surgery referred to Imam Reza hospital. The study have two control and intervention groups, sampling was random in even and odd. Intervention was special care program in the field of activity and rest. In this study, data collection were questionnaires. The Spielberger scale and quality of life after abdominal surgery questionnaires were used. Educational intervention and sports activities before the operation was done and exercise was carried out from the first day after surgery up to 15 days to be determined its impact on anxiety and quality of life on patients had abdominal surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010616104N1
Registration date:2015-07-21, 1394/04/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-21, 1394/04/30
Registrant information
Name
Samira Fatahi
Name of organization / entity
Tarbiat Modares Uneversity
Country
Iran (Islamic Republic of)
Phone
+98 918 995 2019
Email address
samira.fatahi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Asseess the effect of program based on specific care plan in motion and rest on anxiety and quality of life in patients with abdominal surgery.
Public title
The impact of training and activity on quality of life and anxiety in patients with abdominal surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: no special physical and mental chronic diseases such as cancer, severe depression and any movement disorder; lack of drug addiction and lack of strong analgesics use; proficiency in Persian; lack of education in the field of medical science; not taking antianxiety drugs. Exclusion criteria: the need for further surgery or readmission to the hospital.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized sampling in intervention and control groups were even and odd.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway, Nasr (Gisha) Bridge, Tehran, Iran
City
Tehran
Postal code
331-14115
Approval date
2013-11-24, 1392/09/03
Ethics committee reference number
د52/ 4917
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention، after intervention,15 days after intervention
Method of measurement
Spielberger questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention, 15 days after intervention
Method of measurement
Short term health related qol after abdominal surgery
Intervention groups
1
Description
Control group: the control group received only the usual of drug treatment protocols in hospital and recommendations of the surgeon and nurses at discharge was done.
Category
Lifestyle
2
Description
Intervention group: for the inetrvention group before surgery training pamphlet about activities to be taught how to do its are given to patients. Then the first day after surgery and 15 days after surgery they perform activities.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital of Kermanshah
Full name of responsible person
Samira Fatahi
Street address
Sayyad-e-shirazi blvd, Kermanshah, Iran
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
tarbiat modares university
Full name of responsible person
Saeed Musavian
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway, Nasr (Gisha) Bridge, 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
tarbiat modares university
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
Tarbiat Modares University
Full name of responsible person
Samira Fatahi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway, Nasr (Gisha) Bridge, Tehran, Iran
City
Tehran
Postal code
Phone
+98 918 995 2019
Fax
Email
samira.fatahi@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sima Mohamad Khan Kermanshahi
Position
PhD in Nursing ( Assisstant Professor)
Other areas of specialty/work
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway, Nasr (Gisha) Bridge, Tehran, Iran
City
Tehran
Postal code
Phone
+98 82883899
Fax
Email
kerman_s@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Samira Fatahi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway, Nasr (Gisha) Bridge, Tehran, Iran
City
Tehran
Postal code
Phone
+98 918 995 2019
Fax
Email
samira.fatahi@modares.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)