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IRCT20141115019957N2 IRCT 2019-09-10 Iran University of Medical Sciences The effect of cognitive behavioral therapy and biofeedback on physical-psychological symptoms of patients with dyssynergic defecation 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. 2014-04-19 anticipated 45 Complete https://irct.ir/trial/39397 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: Biofeedback with CBT treatment has not been done for the problem of dyssynergic defecation until now, 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. N/A Patients with dysfunctional defecation (dyssynergic defecation). Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not made a decision to publish yet
public Afsaneh Nikjooy
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 nikjooy.a@iums.ac.ir Iran University of Medical Sciences scientific Afsaneh Nikjooy
Iran University of Medical Sciences, Shahid Hemmat Highway,Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 nikjooy.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 25 years 60 years Both 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 K59.09 Other constipation Treatment - Other Treatment - Other Lifestyle 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. 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. 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. Anxiety. Timepoint: before and after intervention. Method of measurement: Spielberger Inventory. Depression. Timepoint: before and after intervention. Method of measurement: Beck Inventory. 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. Quality of life. Timepoint: Before and after intervention. Method of measurement: Quality of life questionnaire SF36. Paradoxical contraction of Puborectalis muscle. Timepoint: Before and after treatment. Method of measurement: Digital rectal examination. Iran University of Medical Sciences Approved 2015-10-17 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)