Electromyographic Biofeedback Therapy in Patients With Dyssynergic Defecation
ConditionDefecation Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorKocaeli University
About this trial
This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on the quality of life and sleep quality of individuals diagnosed with dyssynergic defecation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of dyssynergic defecation was confirmed by anorectal manometry, which demonstrated paradoxical pelvic floor muscle contraction and/or inadequate relaxation during defecation.
Eligibility for a pelvic floor rehabilitation program was based on a comprehensive evaluation conducted at the Physical Medicine and Rehabilitation Clinic.
Age between 18 and 70 years.
A history of chronic constipation lasting at least six months, in accordance with the Rome IV diagnostic criteria.
Disqualifiers
Presence of communication barriers that may interfere with participation in the study.
Cognitive impairment affects the ability to comply with rehabilitation programs or assessments.
Pregnancy.
Presence of severe depression and/or anxiety disorder.
Trial design
Design model
Parallel
Treatments tested in this trial
Game-Based Electromyographic (EMG) Biofeedback Therapy
DeviceGame-based biofeedback integrates real-time visual feedback with interactive tasks, allowing patients to actively control on-screen elements through appropriate muscle activation and relaxation. This approach supports motor learning principles, promotes neuromuscular adaptation, and may improve treatment compliance.
Sham Control
DeviceSham EMG biofeedback therapy will be administered alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration. Surface electrodes will be placed in the same anatomical locations; however, the biofeedback device will operate in demo mode, and visual feedback will not reflect actual muscle activity.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Biofeedback GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Assessment of Constipation-Quality of Life Questionnaire
The Patient Assessment of Constipation-Quality of Life questionnaire is a validated and reliable patient-reported outcome measure developed to assess the impact of chronic constipation on the quality of life. The scale consists of 28 items grouped into four subdomains. * Physical Discomfort: Assesses constipation-related physical symptoms and bodily discomfort. * Psychosocial Discomfort: Evaluates the impact of the condition on emotional status, social functioning, and psychological well-being. * Worries and Concerns: Assesses anxiety, concerns, and illness-related perceptions associated with constipation. * Satisfaction: Evaluates patients' satisfaction with their current bowel function and treatments. Each item is scored on a 5-point Likert scale, with higher scores indicating a greater negative impact on the quality of life.
Time frame
At baseline, immediately after the intervention, and 2-months after the intervention.Secondary outcomes
1
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index is a self-reported questionnaire that assesses sleep quality over 1-month period. The measure consists of 19 individual items, creating seven components that produce one global score, and takes 5-10 minutes to complete. Each item is weighted on a 0-3 interval scale. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with lower scores denoting healthier sleep quality.
Time frame
At baseline, immediately after the intervention, and 2-months after the intervention.2
Constipation Severity Instrument
Constipation severity will be evaluated using the Constipation Severity Instrument, which assesses the severity of constipation-related symptoms and their impacts on daily life. It uses a five-point Likert scale (0-4), resulting in a total score from 0-73, where higher scores indicate greater severity.
Time frame
At baseline, immediately after the intervention, and 2-months after the intervention.3
Bristol Stool Scale
The Bristol Stool Scale categorizes human feces into seven types based on their shape and consistency, ranging from constipation (types 1-2) to diarrhea (types 5-7). This classification facilitates the objective monitoring of changes in bowel habits by assessing stool form and consistency.
Time frame
At baseline, immediately after the intervention, and 2-months after the intervention.4
Visual Analog Scale
Pain intensity and defecation-related discomfort will be measured using the Visual Analog Scale, a widely used tool for quantifying subjective pain perception. It is resulting in a total score from 0-100 mm, where higher scores indicate severe pain.
Time frame
At baseline, immediately after the intervention, and 2-months after the intervention.Sponsors and contacts
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Source ClinicalTrials.gov