The purpose of Biofeedback is that the patient improve or control his or her reaction voluntarily, with the feedback from Physiological processes that is reachable with electrical sensors.
This research is a semi experimental study that is done on 30 women in 15-65 years old with fecal outlet obstruction disorders who have visited surgeon's clinic in Shahrood.
Biofeedback is performed once a week during 8 weeks. according to inclusion and exclusion criteria, the questionnaire is completed for each patients, before Biofeedback is performed.
after 8 weeks patients are visited and the questionnaires are completed again. Eventually the condition of patients will compared before and after biofeedback therapy and data analysis is done to reach results.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022132712N1
Registration date:2017-05-15, 1396/02/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-15, 1396/02/25
Registrant information
Name
Maryam Heydari
Name of organization / entity
Islamic Azad University, Shahrood Branch
Country
Iran (Islamic Republic of)
Phone
+98 23 3236 0080
Email address
maryam.h2017@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Shahrood Branch
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness of Biofeedback Therapy on Women with Fecal Outlet Obstruction Disorders
Public title
Effectiveness of Biofeedback Therapy on Fecal Outlet Obstruction Disorders.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having fecal outlet obstruction disorder; Having history of defecation with excessive straining and normal times of defecation; Constipation is not caused by secondary factors; Muscle weakness is caused by curable reasons like rectocele and rectal prolapse; Lacking of colon's pathology that is creating constipation like Colorectal cancer.Exclusion criteria: Having Serious illnesses that effects on quality of life like sever diabetes, Immunological disorders, psychological disorders and addiction; Patients who have past convalescence over 3 months; The patients under 15 or over 65; Having other disorders like fecal incontinence; Use of any other treatment methods during research.
Age
From 15 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
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
Islamic Azad University, Shahrood
Street address
Islamic Azad University of Shahrood Branch building, Daneshgah Blvd, Shahrood, Semnan Province
City
Shahrood
Postal code
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1395.14
Health conditions studied
1
Description of health condition studied
Fecal outlet obstruction disorders
ICD-10 code
K59
ICD-10 code description
Other functional intestinal disorders
Primary outcomes
1
Description
Evaluate the severity of clinical symptoms before and after biofeedback therapy
Timepoint
Early of intervention and 8 weeks after that
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Evaluate the duration of defecation before and after biofeedback therapy
Timepoint
Early intervention and 8 weeks after that
Method of measurement
Questionnaire
2
Description
Evaiuate the times of defecation before and after biofeedback therapy
Timepoint
Early intervention and 8 weeks after that
Method of measurement
Questionnaire
Intervention groups
1
Description
Biofeedback therapy, Training pelvic muscle exercise and Recommendations for having a correct life style
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Medical Complex
Full name of responsible person
Maryam Heydari
Street address
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Shahrood Branch
Full name of responsible person
Dr.Saheb Ali Manafii
Street address
Islamic Azad University of Shahrood Branch building, Daneshgah Blvd, Shahrood, Semnan Province
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Shahrood Branch
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
Islamic Azad University, Shahrood Barnch
Full name of responsible person
Maryam Heydari
Position
Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahrood Branch building, Daneshgah Blvd, Shahrood, Semnan Province
City
Shahrood
Postal code
Phone
+98 23 3239 0360
Fax
Email
Maryam.H2017@iau-shahrood.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Shahrood
Full name of responsible person
Dr.Fateme Amirkhalili
Position
General Surgeon Specialist
Other areas of specialty/work
Street address
Islamic Azad University of Shahrood Branch building, Daneshgah Blvd, Shahrood, Semnan Province
City
Shahrood
Postal code
Phone
+98 23 3239 0360
Fax
Email
dr.amirkhalili@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Shahrood
Full name of responsible person
Maryam Heydari
Position
Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahrood Branch building, Daneshgah Blvd, Shahrood, Semnan Province
City
Shahrood
Postal code
Phone
+98 23 3239 0360
Fax
Email
Maryam.H2017@iau-shahrood.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)