Effect of Acupressure in The Management of Postmenopausal Constipation

NCT06720077 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/004870
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to investigate the effect of acupressure in the management of constipation in postmenopausal women.

Conditions

Constipation

Outcome Measures

Primary Outcomes (2)

• Patient Assessment of Constipation Symptom (PAC - SYM)

  It is a reliable and valid tool to measure the patient's perspective constipation symptoms in terms of frequency and severity, It is a 12- item that is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Like scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.

  6 weeks

• Patient Assessment of Constipation quality of life (PAC - QOL)

  The PAC-QOL questionnaire is used to evaluate the quality of life of patients having constipation. It is a brief but comprehensive tool which evaluates constipation through daily individual health assessment and functioning. This questionnaire consists of 28 self-reported items which sub-categorized to 4 items on physical discomfort, 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. Lower scores indicate higher quality of life.

  6 weeks

Study Arms (2)

acupressure + diaphragmatic breathing exercises + general bowel care advise

EXPERIMENTAL

It consisted of 30 postmenopausal women. Each of them received acupressure on the (san jio 6/ stomach 25/ spleen 15/ joining vally " large intestine 4 ") acupoints, 1 minute for each point with 3 repetitions on both sides (about 30 minutes as total time), 3 times per week in addition to diaphragmatic breathing exercises for 15 minutes and general bowel care advise, for 6 weeks.

Other: Acupressure; Other: Diaphragmatic breathing exercises; Other: General bowel care advise

diaphragmatic breathing exercises + general bowel care advise

ACTIVE COMPARATOR

It consisted of 30 postmenopausal women who performed diaphragmatic breathing exercises for 15 minutes 3 times per week in addition to general bowel care advice only, for 6 weeks.

Other: Diaphragmatic breathing exercises; Other: General bowel care advise

Interventions

Acupressure OTHER

It will be applied for the experimental group only. Before starting the first treatment session, the participants will be instructed briefly about the nature of the treatment to gain their confidence and cooperation. Each participant in this group will be asked to lie in supine position and the acupressure will be applied by using the therapist's fingers on the following acupoints (san jio 6/ spleen 15/ stomach 25/ joining vally " intestine 4") 1 minute for each point with 3 repetitions on both sides (about 30 minutes as total time), 3 times per week for 6 weeks.

acupressure + diaphragmatic breathing exercises + general bowel care advise

Diaphragmatic breathing exercises OTHER

A modified exercise will be used to achieve normal diaphragmatic breathing while the woman is lying on her back, with one hand placed on her abdomen and the other on her thorax. She will then be instructed to breathe in deeply, slowly, and gradually for 4 seconds, hold the air for 2 seconds, and exhale slowly through pursed lips for 6 seconds. Three series of ten repetitions will be completed with rest in between; the woman will be advised to rest longer if she feels dizzy or lightheaded. The patient will ensure the exercise is performed successfully if the hand placed on the abdomen shows greater mobility compared to minimal or no mobility of the hand on the thorax. From that point, the series of repetitions will begin.

acupressure + diaphragmatic breathing exercises + general bowel care advise; diaphragmatic breathing exercises + general bowel care advise

General bowel care advise OTHER

All women in both groups will receive bowel care advice, including encouraging fiber intake (20-35 g/day) from sources like whole grains, fruits, vegetables, and legumes, with a focus on soluble fiber. They will be advised to limit meat, dairy, and low-fiber foods and avoid caffeine-containing products like chocolate and coffee. Adequate hydration (1.5-2.0 L/day) with water or juices will be recommended, along with daily exercise, such as 20-30 minutes of walking. Proper toilet posture will be emphasized, including sitting with knees higher than hips (using a stool if needed), leaning forward, placing elbows on knees, relaxing, and maintaining a straight spine.

acupressure + diaphragmatic breathing exercises + general bowel care advise; diaphragmatic breathing exercises + general bowel care advise

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sixty postmenopausal women who were clinically diagnosed as having functional constipation after menopause (at least one year after the stoppage of the last menstrual cycle)
• Their ages ranged from 50 to 60 years old.
• Their body mass index didn't exceed 30 kg/m2.
• All of them should have at least two criteria of Rome III diagnostic criteria of constipation.
• They should stop laxatives intake during the treatment program.

You may not qualify if:

• Irritable bowel syndrome or anal fissures.
• Genital organ prolapse as rectocele.
• Any neurological diseases, spinal diseases or spinal deformities.
• History of bowel surgery.
• Congenital anorectal malformation, stoma in situ.
• Diabetes mellitus and sever distal venous insufficiency.
• Skin eruption at the site of stimulation.
• Implanted pacemaker or defibrillator.
• Metalic implant in lower limb.
• Recent surgery at the lower limb.
• Peripheral neuropathy and neurological disorders.
• Psychological distress.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Constipation

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Azza Barmoud Nashed Kassab, PhD

  Professor, Cairo university

  STUDY CHAIR

Central Study Contacts

Samar Gamal Mohamed Gab Allah, B.Sc

CONTACT

01111660110; samargamalpt91@gmail.com

Manal Ahmed El-Shafei, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 7, 2024
• Primary Completion: February 20, 2025
• Study Completion: March 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

EG (1)