Effectiveness of Self-Administered Acupressure Intervention in Managing Constipation of Adult Psychiatric In-Patient

NCT07039448 | Recruiting

• 1 other identifier: IRB-2024-301
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Constipation; Psychiatric Drug Induced Constipation; Constipation Drug Induced

Keywords

constipation; psychiatric in-patient

Outcome Measures

Primary Outcomes (4)

• 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'.

  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).

  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.

  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

  Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention

Secondary Outcomes (1)

• Patient's quality of life

  Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention

Other Outcomes (2)

• Participants' perceptions of the benefits of the intervention

  8-weeks after post-intervention

• Nurses' perceptions of the intervention

  8-weeks after post-intervention

Study Arms (2)

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.

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.

Behavioral: Sham Comparator

Interventions

Acupressure BEHAVIORAL

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.

Treatment Group

Sham Comparator BEHAVIORAL

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.

Sham Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

Castle Peak Hospital

Tuenmen, New Territories, Hong Kong

RECRUITING

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

Central Study Contacts

Kelvin Wai Kit WONG, Assistant Professor

CONTACT

+852-3970-8752; kwkwong@hkmu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Nursing and Health Sciences

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 26, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)