Effect of Acupressure in The Management of Postmenopausal Constipation

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

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation
• Intervention / Treatment: Other: Acupressure; Other: Diaphragmatic breathing exercises; Other: General bowel care advise

Detailed Description

Constipation is prevalent in menopause, affecting 4-29% of women globally, and can lead to serious complications like hemorrhoids, anal fissures, and colorectal cancer. While laxatives can help, long-term use may cause dependency and side effects. Alternative therapies are needed.

Deep breathing, particularly diaphragmatic breathing, may improve constipation by activating the parasympathetic system and promoting relaxation. Acupressure has also shown potential in managing constipation by stimulating intestinal activity, improving blood circulation, and regulating Qi flow.

Despite existing studies on acupressure and constipation, no research has specifically examined its effect on postmenopausal women. This study aims to investigate acupressure's impact on functional constipation in this population, offering potential insights for non-pharmacological management.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manal Ahmed El-Shafei, PhD
• Study Contact Backup: Name: Samar Gamal Mohamed Gab Allah, B.Sc; Phone Number: 01111660110; Email: samargamalpt91@gmail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of physical therapy, Cairo University
    • Contact: Manal Ahmed El-Shafei, PhD
    • Contact: Samar Gamal Mohamed Gab Allah, B.Sc; Phone Number: 01111660110; Email: samargamalpt91@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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)
2. Their ages ranged from 50 to 60 years old.
3. Their body mass index didn't exceed 30 kg/m2.
4. All of them should have at least two criteria of Rome III diagnostic criteria of constipation.
5. They should stop laxatives intake during the treatment program.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupressure + diaphragmatic breathing exercises + general bowel care advise; 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; 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.; Other: Diaphragmatic breathing exercises; 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.; Other: General bowel care advise; 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.
Active Comparator: diaphragmatic breathing exercises + general bowel care advise; 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; 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.; Other: General bowel care advise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Azza Barmoud Nashed Kassab, PhD, Professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): December 7, 2024
• Primary Completion (Estimated): February 20, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: P.T.REC/012/004870

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No