Effect of Acupressure in The Management of Postmenopausal Constipation
NCT ID: NCT06720077
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-12-07
2025-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
50 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Samar Gamal Mohamed Gab Allah
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Azza Barmoud Nashed Kassab, PhD
Role: STUDY_CHAIR
Professor, Cairo university
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of physical therapy, Cairo University
Giza, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Manal Ahmed El-Shafei, PhD
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Samar Gamal Mohamed Gab Allah, B.Sc
Role: primary
Manal Ahmed El-Shafei, PhD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P.T.REC/012/004870
Identifier Type: -
Identifier Source: org_study_id