## Protocol Section
### Identification Module
**NCT ID:** NCT06414525

**Brief Title:** Effect of Abdominal Massage Versus Visceral Manipulation on Constipation

**Official Title:** Effect of Abdominal Massage Versus Visceral Manipulation on Constipation Status and Quality of Life in Adults

#### Organization Study ID Info
**ID:** constipation
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Mennat Allah Mohamed Ali Ahmed

**Investigator Title:** head of department of physical therapy AboKhalefa hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The study compares the effect of abdominal massage vs. visceral manipulation on constipation status and quality of life in adults.

Chronic idiopathic constipation (CIC) is considered a common functional bowel disorder characterized by difficult, infrequent, and/or incomplete defecation. It has a great impact on the quality of life and on the healthcare system and represents an important financial strain .

### Conditions Module

**Conditions:**

- Constipation Chronic Idiopathic

**Keywords:**

- chronic idiopathic constipation

- abdominal massage

- visceral manipulation

- quality of life

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 75

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The technique involves stroking and kneading the abdomen in a consistent pattern.

**Intervention Names:**

- Other: abdominal massage

**Label:** Abdominal massage

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The technique involves visceral connective tissue manipulation.

**Intervention Names:**

- Other: visceral manipulation

**Label:** visceral manipulation

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** instructions on daily, dietary, toilet, and physical activity habits

**Intervention Names:**

- Other: instructions on daily, dietary , toilet , and physical activity habits

**Label:** control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Abdominal massage

**Description:** It will include patients that will receive abdominal massage; the frequency and duration of the massage will be arranged as 3 sessions per week, with each session lasting an average of 20-25 minutes for 6 weeks.

**Name:** abdominal massage

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- visceral manipulation

**Description:** It will include patients that will receive visceral manipulation; the frequency and duration of the technique will be arranged as 3 sessions per week, with each session lasting an average of 20-25 minutes for 6 weeks.

**Name:** visceral manipulation

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- control

**Description:** It will include patients that will receive behavioral therapy: defecation mechanism and informing about negative attitudes and behaviors towards defecation), lifestyle advice (diet, water consumption, fiber food, etc.), teaching effective defecation posture, and timed toilet training.

**Name:** instructions on daily, dietary , toilet , and physical activity habits

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. The Constipation Severity Instrument is a 16-item patient-reported outcome measure that investigates symptoms of constipation based on frequency, severity, and bother of symptoms. CSI consists of three subscales: obstructive defecation, colonic inertia, and pain.

Higher scores of CSI indicate more severe constipation.

**Measure:** Constipation Severity Instrument (CSI)

**Time Frame:** 6 weeks

**Description:** Constipation assessment scale will be used to evaluate the severity of the constipation. The constipation assessment scale is a eight-item scale that assess the presence and severity of constipation.

The patient rates each constipation item on a three-point scale (no problem to severe problem). Total scores range from 0 (no constipation) to 16 (worst possible constipation).

**Measure:** Constipation Assessment Scale

**Time Frame:** 6 weeks

**Description:** Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. PAC-QOL consists a total of 28 items in four subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life.

**Measure:** Patient Assessment of Constipation- Quality of Life (PAC-QOL) Questionnaire

**Time Frame:** 6 weeks

**Description:** (Scale 0 - 100), will be calculated as the mean of three variables (ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation) was developed to evaluate bowel function.

**Measure:** Bowel Function Index

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients of both sex with age ranges (20-40) years old.
* having a diagnosis of functional constipation according to Rome IV criteria onset of constipation symptoms from 6-12 months .
* having body mass index 18.5-29.9 kg/m2 , waist height ratio \</=0.5
* Subjects bothered by their constipation

Exclusion Criteria:

* Pregnancy.
* Having comorbidities (chronic pelvic pain, neurological (Parkinson's, multiple sclerosis, spinal cord lesion, etc.), metabolic / endocrine (diabetes mellitus, hypercalcemia, hypothyroid, etc.), cardiorespiratory diseases
* Health problems which may prevent standing from sitting, walking (orthopedic, neurological, cardiorespiratory, etc.)
* Malignancy, acute inflammation, intestinal tumor
* History of gastrointestinal and pelvic surgery or spinal surgery other than cholecystectomy, appendectomy, or hysterectomy
* Visual, auditory or cognitive problems which may prevent participation to the study.
* Tumor, presence of skin problems in the application area
* Presence of laxative use for functional constipation in the last four weeks or patients on laxative therapy.
* Alarm symptoms (unexplained, more than 10% weight loss in 3 months, hemorrhoids and anal fissures, rectal bleeding, family history of colon cancer)

**Maximum Age:** 40 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mennamohamed309@gmail.com

**Name:** Mennat Allah Ahmed

**Phone:** 01228423121

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ismailia

**Country:** Egypt

**Facility:** Abo Khalefa emergency hospital

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M6472

- Name: Constipation

- Relevance: HIGH

- As Found: Constipation

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003248

- Term: Constipation

### Misc Info Module

- Version Holder: 2024-05-31
