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The Effect of Biofeedback Therapy (BFT) with Cognitive Behavioral Therapy (CBT) on the Quality of Life, Anxiety, Depression and Somatic Symptoms in Patients with Dyssynergic Defecation.

Protocol summary

Study aim
The effect of of biofeedback therapy and cognitive behavioral therapy on quality of life, psychological and physical symptoms in dyssynergic defecation patients.
Design
A total of 45 patients enrolled between April 2017 and December 2017, were randomly allocated to 3 parallel groups in a controlled clinical trial.
Settings and conduct
The patients were divided in three groups.They received biofeedback therapy with cognitive-behavior therapy, biofeedback therapy, and standard therapy. Assessment were done by questionnaires such as; the Short Form-36 quality of life , Spielberger Anxiety, Beck depression and Constipation scoring system, also digital rectal exam before and after treatment.This study conducted in Physiotherapy clinic of Rehabilitation Faculty in Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion; Patients with defecation disorder, hard stools, incomplete evacuation and digital manipulation in more than 1/4 of bowel movements.Diagnosis of paradoxical function of puborectalis with examination. Exclusion; history of anorectal surgery and tumors, structural anorectal disorders leads to surgery,constipation because of endocrine and metabolic diseases, severe cardiovascular, respiratory, neurological, psychological problems.
Intervention groups
Intervention group ; biofeedback therapy (BFT: correction of defecation pattern by pelvic floor relaxation training using biofeedback device (Enraf.co) during 60 minutes twice a week for 12 sessions; then once a week for 6 sessions) and cognitive behavioral therapy (CBT: identification of self-defeating behavior patterns and thoughts in six sessions.). control 1; BFT (as above) control 2; standard therapy (STT: advise about nutrition and daily exercises and control for three months.)
Main outcome variables
ًQuality of life, physical symptom: constipation, psychological symptoms: anxiety, depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141115019957N2
Registration date: 2019-09-10, 1398/06/19
Registration timing: retrospective

Last update: 2019-09-10, 1398/06/19
Update count: 0
Registration date
2019-09-10, 1398/06/19
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
nikjooy.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-04-19, 1393/01/30
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
2014-04-19, 1393/01/30
Actual recruitment end date
2019-03-16, 1397/12/25
Trial completion date
2019-03-16, 1397/12/25
Scientific title
The Effect of Biofeedback Therapy (BFT) with Cognitive Behavioral Therapy (CBT) on the Quality of Life, Anxiety, Depression and Somatic Symptoms in Patients with Dyssynergic Defecation.
Public title
The effect of cognitive behavioral therapy and biofeedback on physical-psychological symptoms of patients with dyssynergic defecation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with functional chronic constipation and strain for defecation The patients who had hard stools, incomplete evacuation and digital manipulation in more than 1/4 of bowel movements The patients with diagnosis of paradoxical contraction of the puborectalis muscle during straining established by digital rectal examination (DRE) and also diagnostic test such as anorectal manometry or defecography or balloon expulsion test
Exclusion criteria:
History of anorectal surgery Anorectal tumors Structural anorectal disorders leaded to surgery Constipation because of endocrine diseases Severe cardiovascular problems Severe respiratory problems Severe neurologic problems Severe psychological problems Constipation because of metabolic diseases
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed using Excel software that way, we generated random numbers from 1 to 3, and numbers between 0 and 1 was assigned into the first group, numbers between 1 and 2 (except for 1) was assigned into the second group and the numbers between 2 and 3 (except 2) was assigned into the third group of treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Biofeedback with CBT treatment has not been done for the problem of dyssynergic defecation until now

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, Shahid Hemmat Highway,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.IUMS.REC.1394.19397

Health conditions studied

1

Description of health condition studied
Patients with dysfunctional defecation (dyssynergic defecation)
ICD-10 code
K59.09
ICD-10 code description
Other constipation

Primary outcomes

1

Description
Anxiety
Timepoint
before and after intervention
Method of measurement
Spielberger Inventory

2

Description
Depression
Timepoint
before and after intervention
Method of measurement
Beck Inventory

3

Description
Constipation
Timepoint
Before and after intervention
Method of measurement
The symptoms of constipation were checked by the Constipation Scoring System (CSS) before and after the treatment, with a 30-point questionnaire, which points to more severity of constipation.

4

Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
Quality of life questionnaire SF36

5

Description
Paradoxical contraction of Puborectalis muscle
Timepoint
Before and after treatment
Method of measurement
Digital rectal examination

Secondary outcomes

empty

Intervention groups

1

Description
The treatment of the "Intervention group" included biofeedback therapy simultaneously with cognitive behavioral therapy. A physiotherapist specialized in pelvic floor dysfunction conducted the Biofeedback therapy. At the beginning of the first treatment session; the physiology of defecation and pathophysiology of dyssynergic defecation were explained to the patients.The biofeedback was done by simulated defecation which synchronized with visual /verbal feedback method for training the pelvic floor relaxation.This procedure was consisting of inserting a pressure probe into the patient’s rectum, and also a surface electrode on abdominal muscles, to monitor the activity of the muscles.Then, they were taught “Abdominal Recto Anal Coordination Training” method, to coordinate their abdominal push effort and concurrent relaxation of the anal sphincter and the puborectalis muscles which depicted by decreased anal pressure on the monitor. The duration of the biofeedback therapy session was 60 minutes twice a week for 12 sessions; then once a week for 6 sessions, that is, 18 sessions in total. Cognitive behavioral therapy was conducted by a psychologist consisting of six sessions, through which the patients were helped to identify the self-defeating behavior patterns and maladaptive thoughts that could have a harmful effect on mental well-being, life functioning and symptomatic experience. The treatment sessions were held individually, once a week, for 45 minutes, including: 1- History taking and rapport establishing. 2- Clarifying the effectiveness of psychological treatment on reducing physical symptoms. 3- Identifying psychological disorders, training the treatment model and drawing the relationship between thoughts, feelings and behaviours on mental disorder with considering the patient's problem. 4- Teaching a suitable technique for evaluating thoughts (credibility and usefulness). 5- Training for identifying the cognitive errors and providing coping skills and problem solving. 6- Concluding the treatment pathway and providing a solution to prevent recurrence.
Category
Treatment - Other

2

Description
The treatment of the "Control group 1" only included Biofeedback therapy. A physiotherapist specialized in pelvic floor dysfunction conducted the Biofeedback therapy. At the beginning of the first treatment session; the physiology of defecation and pathophysiology of dyssynergic defecation were explained to the patients. The biofeedback was done by simulated defecation which synchronized with visual /verbal feedback method for training the pelvic floor relaxation.This procedure was consisting of inserting a pressure probe into the patient’s rectum, and also a surface electrode on abdominal muscles, to monitor the activity of the muscles. Then, they were taught “Abdominal Recto Anal Coordination Training” method, to coordinate their abdominal push effort and concurrent relaxation of the anal sphincter and the puborectalis muscles which depicted by decreased anal pressure on the monitor. The duration of the Biofeedback therapy session was 60 minutes twice a week for 12 sessions; then once a week for 6 sessions, that is, 18 sessions in total.
Category
Treatment - Other

3

Description
The "Control group 2 " received standard treatment .This group was avoided from medical treatment, and was encouraged to take sufficient fiber, water and taking part in daily exercises. Also, the patients of this group were trained attempting to have a bowel movement twice a day, usually 30 minutes after meals or walking (Timed Toilet Training). During attempted defecation, the straining should not be taken more than 5 minutes. The patients were advised not to use digital maneuvers to disimpact the fecal. Also they were taught the correct position of defecation and diaphragmatic breathing during defecation for increasing intra-abdominal pressure for facilitating the defecation process. Duration of treatment was three months and the patients were controlled once a week on the phone.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Tehra
Full name of responsible person
Afsaneh Nikjooy
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Shah Nazari St, Mother Square, Mirdamad Alley,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
nikjooy.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Deputy of Research of Iran University of Medical Sciences,Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
malakouti.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Nikjooy
Position
Assistant Professor in Iran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
nikjooy.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Nikjooy
Position
Assistant Professor at Iran university of medical sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
nikjooy.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Afsaneh Nikjooy
Position
Assistant Professor at Iran university of medical sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway,
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
nikjooy.a@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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