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The goal of this clinical trial is to learn if a combined exercise and abdominal massage program improves bowel function and daily well-being in children with functional constipation. Researchers will compare this program with standard care by measuring bowel symptoms, rectal size, pelvic floor strength, trunk endurance, and quality of life.
This clinical trial includes children with functional constipation. Participants will be randomly assigned to either a combined exercise and abdominal massage program or to standard care and education.
Children in the program group will take part in guided exercise sessions and receive abdominal massage, while the standard care group will receive routine follow-up and advice on bowel habits.
Researchers will measure bowel symptoms, bowel movement patterns, rectal diameter, pelvic floor muscle function, trunk muscle endurance, and quality of life before and after the program.
The results may help improve safe, non-drug treatment options for children with constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Participants in the control group will receive standard care and education related to bowel habits and lifestyle recommendations. |
|
| Intervention Group | Experimental | Participants in the intervention group will receive standard care plus a combined exercise training and abdominal massage program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stretching, Strengthening, and Stabilization Exercises | Other | Children will complete exercises to improve flexibility, muscle strength, and trunk stability. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rectal Diameter (measured by ultrasound) | Rectal diameter will be measured using abdominal ultrasonography to assess rectal distension related to functional constipation. Measurements will be performed before the intervention and at the end of the eight-week program. Changes in rectal diameter will be used to evaluate the effectiveness of the combined exercise and abdominal massage program. | Baseline and after eight weeks |
| Constipation Symptoms (Rome IV Diagnostic Criteria) | Constipation symptoms will be assessed using the Rome IV diagnostic criteria for functional constipation, including bowel movement frequency, fecal incontinence, painful or difficult defecation, stool withholding behavior, and presence of large stools. | Baseline and after eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Function (Bowel Diary + Bristol Stool Scale) | Bowel function will be evaluated using a 7-day bowel diary including stool frequency and stool consistency (Bristol Stool Scale, Types 1-7). The diary will be completed for one week at baseline and for one week after the 8-week program. | Baseline and after eight weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zeynep I sevimli, PT, MSc | Contact | +905063720373 | idilsevimli@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zeynep I sevimli, PT, MSc | Fizyofit Pilates Stüdyosu / Ankara Bilkent City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital - Pediatric Surgery Clinic | Ankara | Ankara | Turkey (Türkiye) |
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Participants will be randomly assigned to either an intervention group or a control group and followed in parallel throughout the study period.
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| Abdominal Massage (I Love You Technique) | Other | Gentle abdominal massage will be applied following the colon pathway to support bowel movement. |
|
| Standard Care and Education | Behavioral | Children and their parents will receive education about bowel function and lifestyle guidance on diet, fluid intake, toileting habits, and physical activity. |
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| Pelvic Floor Muscle Training | Other | Children will practice fast and slow pelvic floor contractions to improve muscle strength and endurance. |
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| Breathing Exercises | Other | Children will perform simple diaphragmatic breathing exercises daily to support abdominal and pelvic muscle coordination. |
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| Pelvic Floor Function |
Pelvic floor muscle function will be evaluated using the Oxford Scale adapted for children. Muscle contraction strength will be graded during a clinical assessment. |
| Baseline and after eight weeks |
| Quality of Life (Visual Analog Scale) | Children's and parents' quality of life will be measured using a Visual Analog Scale ranging from zero to ten, with higher scores indicating greater impact of constipation on daily life. | Baseline and after eight weeks |
| Perceived Improvement (9-Point Patient Global Impression of Change Scale) | Perceived improvement will be evaluated using the 9-point Patient Global Impression of Change Scale. Parents will rate their child's overall change in constipation symptoms compared to the start of the study, with higher scores indicating greater improvement. | After eight weeks |
| Treatment Adherence (Visual Analog Scale) | Adherence to treatment recommendations will be evaluated using a Visual Analog Scale completed by parents, with higher scores indicating better adherence. | After eight weeks |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D004522 | Educational Status |
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
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