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临床试验/NCT07039448
NCT07039448招募中不适用

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

Hong Kong Metropolitan University1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
154
试验地点
1
主要终点
Severity of constipation symptoms

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Acupressure (Behavioral)

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.

干预措施: Sham Comparator (Behavioral)

结局指标

主要结局

Severity of constipation symptoms

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • Patient's quality of life(Pre-intervention, Immediately after intervention, 4-weeks after post-intervention, 8-week after post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Kelvin WONG Wai Kit

Assistant Professor, School of Nursing and Health Sciences

Hong Kong Metropolitan University

研究点 (1)

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