ConstipationNCT06720077
Effect of Acupressure in The Management of Postmenopausal Constipation
A study testing Acupressure, Diaphragmatic breathing exercises and General bowel care advise in people with Constipation, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to investigate the effect of acupressure in the management of constipation in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- Acupressure, Diaphragmatic breathing exercises and General bowel care advise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Dec 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Manal Ahmed El-Shafei, PhD contact
Egypt1 site
Faculty of physical therapy, Cairo University
Giza
Samar Gamal Mohamed Gab Allah, B.Sc, 01111660110, samargamalpt91@gmail.com
Manal Ahmed El-Shafei, PhD
About this study
This study was conducted to investigate the effect of acupressure in the management of constipation in postmenopausal women.
Read the 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.
- Conditions
- Constipation
- Being tested
- Acupressure, Diaphragmatic breathing exercises, General bowel care advise
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
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 exercisesOther
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 adviseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Diaphragmatic breathing exercises; Other: General bowel care advise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start7 Dec 2024 (estimated)
- Primary completion20 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Gamal Mohamed Gab Allah, Cairo University
- Investigators
- Azza Barmoud Nashed Kassab, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720077
- Sponsor's protocol ID
- P.T.REC/012/004870
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure in The Management of Postmenopausal Constipation
- ClinicalTrials.gov ID
- NCT06720077
- Acronym / sponsor ID
- P.T.REC/012/004870
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Dec 2024 (estimated)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to investigate the effect of acupressure in the management of constipation in postmenopausal women.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupressure + diaphragmatic breathing exercises + general bowel care advise | Experimental | Other: Acupressure, Other: Diaphragmatic breathing exercises, Other: General bowel care adviseIt 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. |
| diaphragmatic breathing exercises + general bowel care advise | Active comparator | Other: Diaphragmatic breathing exercises, Other: General bowel care adviseIt 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. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureIt 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 | acupressure + diaphragmatic breathing exercises + general bowel care advise |
| Diaphragmatic breathing exercisesA 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 | acupressure + diaphragmatic breathing exercises + general bowel care advise, diaphragmatic breathing exercises + general bowel care advise |
| General bowel care adviseAll 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. | Other | acupressure + diaphragmatic breathing exercises + general bowel care advise, diaphragmatic breathing exercises + general bowel care advise |
Primary outcome
Patient Assessment of Constipation Symptom (PAC - SYM)
Time frame: 6 weeks
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.
Patient Assessment of Constipation quality of life (PAC - QOL)
Time frame: 6 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manal Ahmed El-Shafei, PhD contact
Azza Barmoud Nashed Kassab, PhD study chair
Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure, Diaphragmatic breathing exercises and General bowel care advise in people with Constipation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samar Gamal Mohamed Gab Allah, B.Sc (01111660110, samargamalpt91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Assessment of Constipation Symptom (PAC - SYM) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.