ConstipationNCT07039448
Effectiveness of Self-Administered Acupressure Intervention in Managing Constipation of Adult Psychiatric In-Patient
A study testing Acupressure in people with Constipation and Psychiatric Drug Induced Constipation, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial summary
Constipation is a common gastrointestinal condition characterized by unsatisfactory defaecation as a result of infrequent stools, difficult stool passage, or both. Overall, the average prevalence of constipation was estimated at 16% worldwide. It affects about 14.3% of the population in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Psychiatric Drug Induced Constipation, Constipation Drug Induced
- What is being tested?
- Acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2025to May 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong Chinese residents, aged 18 or above
- Meet the diagnostic criteria of Rome III for constipation
- Mentally stable and competent for self-care and learning acupressure, as recommended by their attending psychiatrists and
- Able to understand the questionnaire and follow instructions for training will be eligible to participate in this study
Who cannot join
- Anatomical and physiological disorders of gastrointestinal tract such as malrotation, fistula and colonic neuropathies
- Metabolic and endocrine diseases
- Lead poisoning and vitamin D intoxication
- Previous training in acupressure
- Physical disability involved the upper limbs
- Planned surgery undergoing during study period and pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Castle Peak Hospital
Tuenmen, New Territories
Bonnie SIU, +852-2456-7111, cph_enquiry@ha.org.hk
Kelvin Wai Kit Wong
About this study
Constipation is a common gastrointestinal condition characterized by unsatisfactory defaecation as a result of infrequent stools, difficult stool passage, or both. Overall, the average prevalence of constipation was estimated at 16% worldwide. It affects about 14.3% of the population in Hong Kong. The condition incurs significant costs, with over £162 million in the UK National Health Service from 2017 to 2018. Similar high expenses are reported in Hong Kong and many Western countries. Studies have shown that constipation can lead to serious health complications, including paralytic ileus, fecal impaction, bowel obstruction, and even premature death. It not only causes patient discomfort and reduces quality of life, but also increases treatment costs.
Psychiatric patients, particularly those on psychotropic drugs such as antipsychotics and antidepressants, are more susceptible to constipation, with over a third affected in Europe. This high prevalence may be due to the side effects of antipsychotics and antidepressant drugs, as well as factors like limited physical activity, sedentary lifestyle, negative symptoms, poor mental state, unhealthy diet, and insufficient fiber intake. The physical health of individuals with severe mental illness, including constipation, has become a major concern in recent years. However, these issues are often overlooked and under-researched, making its management a critical aspect of mental health care.
Read more
Common treatments of constipation include pharmacological and non-pharmacological interventions. While pharmacological intervention can effectively alleviate symptoms, it is a short-term solution but long-term use of laxatives can cause serious side effects such as bloating, allergic reaction, abdominal pain, metabolic disturbances, and hepatotoxicity that can far outweigh the therapeutic effects of symptom reduction. Alternative non-traumatic interventions like auriculotherapy and behavioral therapy have been found to be ineffective. Only one RCT study of abdominal massage therapy to 60 elderlies with constipation in Sweden has shown decrease severity of constipation and increased bowel movement but did not lead to decrease in laxative intake, also the intervention requires a therapist to perform. This may reduce the accessibility and sustainability of the intervention to manage constipation. Therefore, the investigators propose to test a simpler and less expensive intervention to manage constipation to adult psychiatric patient. This intervention incorporates the concept of self-help, acupressure into the project.
Self-help concept: Since the 19th century, self-care has been a crucial element within healthcare systems. It is characterized as a deliberate action undertaken by an individual to enhance health or manage disease. Florence Nightingale underscored the significance of personal hygiene and environmental factors in health, thereby establishing self-care as a fundamental principle in public health nursing. Orem further developed the notion of self-care, classifying it into three categories: universal self-care requisites, developmental self-care requisites, and health-deviation self-care requisites. Barofsky divided self-care activities into four types: regulatory, preventive, reactive, and restorative self-care. Both the World Health Organization and Pender accentuated the function of self-care in health enhancement, disease prevention, and health restoration. In Orem's self-care model, nursing therapeutics are divided into five categories, with patients perceived as active contributors to their own care.
Acupressure: Acupressure involves the application of constant pressure by fingertip, thumb or palm to specific acupoints for stimulating the flow of 'Qi' in the meridians. In TCM, health problems are deemed to be due to pathogenic changes in 'Qi' and imbalance of 'Yin' and 'Yang'. Dysfunction of the viscera and bowels is induced by a deficiency or excess of 'Qi' in the body. The acupressure is based on the Meridian theory that a life force called 'Qi' flows through the body along certain channels (meridians), which if blocked can cause illness. Stimulation at precise locations (acupoints) along these channels by healthcare provider or patients themselves can unblock the flow of 'Qi', relieving pain and restoring health. Acupressure is able to influence autonomic functions, which can affect the functioning of defecation. In addition, Some studies found that acupressure improved symptoms of constipation in elderly, stroke, and vegetative status patients. Acupressure might have positive effect of improving constipation in patients. Unfortunately, there is no trails (RCT or non-RCT) on psychiatric patient. Therefore this intervention will be tested among the psychiatric in-patients in this study.
- Being tested
- Acupressure, Sham Comparator
- Keywords
- constipation, psychiatric in-patient
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureBehavioural
The acupressure intervention including the five acupoints. The acupressure will be performed once a day for 10 days in a group setting with same sex, supervised by a trained psychiatric nurse and preferably at least 2 hours after a meal.
Sham ComparatorBehavioural
The sham group will be trained to perform acupressure in a similar way to the intervention group, except that they will use five sham acupoints. After completion of the project, patients in the sham group will receive the same interventions as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The acupressure intervention including the five acupoints are Zhongwan (RN12), which are located on the upper abdomen and on the anterior midline 4 cun (just over 10 cm) above the center of the umbilicus; the right and left Tianshu (ST25), located in the central abdominal region and 2 cun (just over 5 cm) lateral to the umbilicus; and the right and left Quchi (LI11), located at the lateral end of the transverse elbow crease when the forearm is flexed and at the midpoint of the line connecting Chize (LU5) to the lateral epicondyle of the humerus. The acupressure will be performed once a day for 10 days in a group setting with same sex, supervised by a trained psychiatric nurse and preferably at least 2 hours after a meal. Receives: Behavioral: Acupressure |
| Sham Control Group | Sham comparator | The sham group will be trained to perform acupressure in a similar way to the intervention group, except that they will use five sham acupoints. After completion of the project, patients in the sham group will receive the same interventions as the intervention group. Receives: Behavioral: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of constipation symptoms
Chinese version of Constipation Assessment Scale (C-CAS) will be used to assess the severity of constipation symptom: The 8-item C-CAS has been commonly used with 3-point Likert scale, including '0= no problem', '1= some problem', and '2= severe problem'.
Measured: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention
Number of Complete Spontaneous Bowel Movements
The number of Complete Spontaneous Bowel Movements (CSBM) will be used to measure symptom severity of constipation which is recorded in the Patient's Bowel Movement Chart (MR402351/NTWC).
Measured: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention
Stool form
Bristol Stool Form Scale (BSFS) will be used to measure symptom severity of constipation. The Bristol Stool Form Scale (BSFS), a graded visual scale of stool type from type 1 (hard lumps) to type 7 (watery diarrhea) which is recorded in the Patient's Bowel Movement Chart (MR402351/NTWC), will be used to assess the patient's stool form.
Measured: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention
Use of medication to relieve constipation symptoms
The reduction of using medication to to relive constipation symptoms
Measured: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention
Secondary outcomes (1)
Patient's quality of life
Chinese version of Patient Assessment Constipation Quality of Life Questionnaire (C-PAC-QoL) will be used to assess the specific disease related patient quality of life: The PAC-QoL consists of 28 items categorised into four subscales, including dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items) with 5-point Likert scale, ranging from '0 = none of the time or not at all' to '4 = all of the time or extremely'. The lower average total score indicates the better the person's health-related quality of life.
Measured: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (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.
- 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
- Participant
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Dr Kelvin WONG Wai Kit, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039448
- Sponsor's protocol ID
- IRB-2024-301
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Self-Administered Acupressure Intervention in Managing Constipation of Adult Psychiatric In-Patient
- ClinicalTrials.gov ID
- NCT07039448
- Acronym / sponsor ID
- IRB-2024-301
- Keywords
- constipation, psychiatric in-patient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- Jul 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Jun 2025 (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.
Constipation is a common gastrointestinal condition characterized by unsatisfactory defaecation as a result of infrequent stools, difficult stool passage, or both. Overall, the average prevalence of constipation was estimated at 16% worldwide. It affects about 14.3% of the population in Hong Kong. The condition incurs significant costs, with over £162 million in the UK National Health Service from 2017 to 2018. Similar high expenses are reported in Hong Kong and many Western countries. Studies have shown that constipation can lead to serious health complications, including paralytic ileus, fecal impaction, bowel obstruction, and even premature death. It not only causes patient discomfort and reduces quality of life, but also increases treatment costs.
Psychiatric patients, particularly those on psychotropic drugs such as antipsychotics and antidepressants, are more susceptible to constipation, with over a third affected in Europe. This high prevalence may be due to the side effects of antipsychotics and antidepressant drugs, as well as factors like limited physical activity, sedentary lifestyle, negative symptoms, poor mental state, unhealthy diet, and insufficient fiber intake. The physical health of individuals with severe mental illness, including constipation, has become a major concern in recent years. However, these issues are often overlooked and under-researched, making its management a critical aspect of mental health care.
Common treatments of constipation include pharmacological and non-pharmacological interventions. While pharmacological intervention can effectively alleviate symptoms, it is a short-term solution but long-term use of laxatives can cause serious side effects such as bloating, allergic reaction, abdominal pain, metabolic disturbances, and hepatotoxicity that can far outweigh the therapeutic effects of symptom reduction. Alternative non-traumatic interventions like auriculotherapy and behavioral therapy have been found to be ineffective. Only one RCT study of abdominal massage therapy to 60 elderlies with constipation in Sweden has shown decrease severity of constipation and increased bowel movement but did not lead to decrease in laxative intake, also the intervention requires a therapist to perform. This may reduce the accessibility and sustainability of the intervention to manage constipation. Therefore, the investigators propose to test a simpler and less expensive intervention to manage constipation to adult psychiatric patient. This intervention incorporates the concept of self-help, acupressure into the project.
Self-help concept: Since the 19th century, self-care has been a crucial element within healthcare systems. It is characterized as a deliberate action undertaken by an individual to enhance health or manage disease. Florence Nightingale underscored the significance of personal hygiene and environmental factors in health, thereby establishing self-care as a fundamental principle in public health nursing. Orem further developed the notion of self-care, classifying it into three categories: universal self-care requisites, developmental self-care requisites, and health-deviation self-care requisites. Barofsky divided self-care activities into four types: regulatory, preventive, reactive, and restorative self-care. Both the World Health Organization and Pender accentuated the function of self-care in health enhancement, disease prevention, and health restoration. In Orem's self-care model, nursing therapeutics are divided into five categories, with patients perceived as active contributors to their own care.
Acupressure: Acupressure involves the application of constant pressure by fingertip, thumb or palm to specific acupoints for stimulating the flow of 'Qi' in the meridians. In TCM, health problems are deemed to be due to pathogenic changes in 'Qi' and imbalance of 'Yin' and 'Yang'. Dysfunction of the viscera and bowels is induced by a deficiency or excess of 'Qi' in the body. The acupressure is based on the Meridian theory that a life force called 'Qi' flows through the body along certain channels (meridians), which if blocked can cause illness. Stimulation at precise locations (acupoints) along these channels by healthcare provider or patients themselves can unblock the flow of 'Qi', relieving pain and restoring health. Acupressure is able to influence autonomic functions, which can affect the functioning of defecation. In addition, Some studies found that acupressure improved symptoms of constipation in elderly, stroke, and vegetative status patients. Acupressure might have positive effect of improving constipation in patients. Unfortunately, there is no trails (RCT or non-RCT) on psychiatric patient. Therefore this intervention will be tested among the psychiatric in-patients in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: AcupressureThe acupressure intervention including the five acupoints are Zhongwan (RN12), which are located on the upper abdomen and on the anterior midline 4 cun (just over 10 cm) above the center of the umbilicus; the right and left Tianshu (ST25), located in the central abdominal region and 2 cun (just over 5 cm) lateral to the umbilicus; and the right and left Quchi (LI11), located at the lateral end of the transverse elbow crease when the forearm is flexed and at the midpoint of the line connecting Chize (LU5) to the lateral epicondyle of the humerus. The acupressure will be performed once a day for 10 days in a group setting with same sex, supervised by a trained psychiatric nurse and preferably at least 2 hours after a meal. |
| Sham Control Group | Sham comparator | Behavioral: Sham ComparatorThe sham group will be trained to perform acupressure in a similar way to the intervention group, except that they will use five sham acupoints. After completion of the project, patients in the sham group will receive the same interventions as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hong Kong Chinese residents, aged 18 or above
- Meet the diagnostic criteria of Rome III for constipation
- Mentally stable and competent for self-care and learning acupressure, as recommended by their attending psychiatrists and
- Able to understand the questionnaire and follow instructions for training will be eligible to participate in this study
Key exclusion criteria (6 listed)
- Anatomical and physiological disorders of gastrointestinal tract such as malrotation, fistula and colonic neuropathies
- Metabolic and endocrine diseases
- Lead poisoning and vitamin D intoxication
- Previous training in acupressure
- Physical disability involved the upper limbs
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 |
|---|---|---|
| AcupressureThe acupressure intervention including the five acupoints. The acupressure will be performed once a day for 10 days in a group setting with same sex, supervised by a trained psychiatric nurse and preferably at least 2 hours after a meal. | Behavioural | Treatment Group |
| Sham ComparatorThe sham group will be trained to perform acupressure in a similar way to the intervention group, except that they will use five sham acupoints. After completion of the project, patients in the sham group will receive the same interventions as the intervention group. | Behavioural | Sham Control Group |
Primary outcome
Severity of constipation symptoms
Time frame: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention
Chinese version of Constipation Assessment Scale (C-CAS) will be used to assess the severity of constipation symptom: The 8-item C-CAS has been commonly used with 3-point Likert scale, including '0= no problem', '1= some problem', and '2= severe problem'.
Number of Complete Spontaneous Bowel Movements
Time frame: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention
The number of Complete Spontaneous Bowel Movements (CSBM) will be used to measure symptom severity of constipation which is recorded in the Patient's Bowel Movement Chart (MR402351/NTWC).
Stool form
Time frame: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention
Bristol Stool Form Scale (BSFS) will be used to measure symptom severity of constipation. The Bristol Stool Form Scale (BSFS), a graded visual scale of stool type from type 1 (hard lumps) to type 7 (watery diarrhea) which is recorded in the Patient's Bowel Movement Chart (MR402351/NTWC), will be used to assess the patient's stool form.
Use of medication to relieve constipation symptoms
Time frame: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention
The reduction of using medication to to relive constipation symptoms
1 secondary outcome
Patient's quality of life
Time frame: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention
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 26 Jun 2025.
- Individual participant dataSharing planned: No
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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.
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 in people with Constipation and Psychiatric Drug Induced Constipation, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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 Kelvin Wai Kit WONG, Assistant Professor (+852-3970-8752, kwkwong@hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of constipation symptoms (time frame: Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention). The study lists 4 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 26 Jun 2025.