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the investigation of Impact of psycho educational intervention on physical and psychological symptoms in patients with inflammatory bowel disease

Protocol summary

Summary
The impact of psycho-educational intervention on physical and psychological symptom in patients with inflammatory bowel disease . A total of 60 patients with a confirmed diagnosis of inflammatory bowel disease will enroll in this study. The experiment will be done in Faghihi Clinic in Shiraz, using a clinical trial. First, the study sample will be selected based on convenient sampling. Then, it will be randomized to one group that will receive the intervention being studied (the experimental group) and another group that will not receive the intervention (the control group). The experimental group will receive regular psychoeducational treatment, including healthy diet plans, regular exercise and stress, anxiety, and depression prevention and management for one month, one day a week for 90 minutes. A series of assessments will be administered before patients begin treatment, after 4 weeks, and after 8 weeks. All the information will be collected via HADS questionnaire, SCCI index and CDAI index. Inclusion criteria for this study will be patients with 18 years old and above, the patients that are diagnosed with “IBD” disease and are in the active phase of the disease, the patients that are able to perform physical activity and the patients with no chronic illnesses. The exclusion criteria of the experiment will be the patient's lack of cooperation during the investigation. It is expected that the experimental group, who has received psychoeducation, shows significantly more symptom’s improvement than the control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015041921850N1
Registration date: 2016-01-12, 1394/10/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-12, 1394/10/22
Registrant information
Name
Fateme Pashootan Yalame
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4554
Email address
pashootan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Shiraz University of Medical Sciences
Expected recruitment start date
2015-08-16, 1394/05/25
Expected recruitment end date
2015-09-01, 1394/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the investigation of Impact of psycho educational intervention on physical and psychological symptoms in patients with inflammatory bowel disease
Public title
impact of psychoeducational intervention on patient with inflammatory bowel disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Willingness to participate in the study; Age over 18 years Patients diagnosed with the disease; Patients in the active phase of the disease Ability to perform physical activity; Not with other chronic illnesses Exclusion criteria: patient's lack of cooperation during the investigation
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
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
Parallel
Other design features
block randomization is used in this study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Shiraz University of Medical Sciences
Street address
Central Building of Medical sciences, Zand Street, Shiraz
City
Shiraz
Postal code
71348-14336
Approval date
2014-10-29, 1393/08/07
Ethics committee reference number
CT-9372-7182

Health conditions studied

1

Description of health condition studied
inflammatory bowel disease
ICD-10 code
k50- k51
ICD-10 code description
crohn disease[reginal enteritis]-ulceritive colitis

Primary outcomes

1

Description
Physicall symptom
Timepoint
before the intervention and 4 weeks and 8 weeks after intervention
Method of measurement
Crohn's Disease Activity Index,Clinical Scoring System for the CLINICAL colitis Activity Index

2

Description
psychological intervention
Timepoint
befor the intervention,4 weeks after intervention,8 weeks after intervention
Method of measurement
HADS Questionary

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group training classes for 4 meeting will be held within one month, training include: training, diet, exercise, stress management, anxiety, depression, learning ways to deal with and get instruction for use drug and receive training booklet and patient follow-up by phone
Category
Other

2

Description
The control group did not receive the intervention at the end of the training manual given to them.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Shahid Faghihi Clinic
Full name of responsible person
Molazem Zahra
Street address
Hazrat-e- Fatemeh nursing and midwifery college, Namazi Squer, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research , Shiraz University of Medical Sciences
Full name of responsible person
Dr.Seyyed Basir Hashemi
Street address
Vice chancellor for research, 7th floor , Central Building of Shiraz University of Medical Sciences,Zand Street, Shiraz
City
Shiraz
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 , Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Molazem
Position
PHD in nursing
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi hospital, Namazi Squer, Shiraz
City
Shiraz
Postal code
1978-71345
Phone
+98 71 3647 4254
Fax
Email
Molazemzah@yahoo.com
Web page address
www.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Molazem
Position
master of nursing
Other areas of specialty/work
Street address
Hazrat-e- Fatemeh nursing and midwifery college, Namazi Hospital, Namazi squer, Shiraz
City
Shiraz
Postal code
1978-71345
Phone
+98 71 3647 4254
Fax
Email
Molazemzah@yahoo.com
Web page address
www.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Pashootan Yalameh
Position
M.Sc.Nursing Student
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Squer,Shiraz
City
Shiraz
Postal code
Phone
+98 71 3621 6083
Fax
Email
pashootanfatima@yahoo.com
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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