Spinal Cord Injuries Clinical Trial
Official title:
Effect of Home-based Acupressure on Constipation in People With Spinal Cord Injury: a Study Protocol for a Randomized Controlled Trial With a Mixed-method Approach
Verified date | January 2024 |
Source | The Hong Kong Polytechnic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Spinal cord injury is a multi-sensory, motor and autonomic dysfunction, caused by various types of acute and chronic central nervous system injuries. And it will affect patient's ability to live normally and return to society. Due to lack of physical activity and psychological and environmental factors, the feces remain in the intestine for too long, and there will be excessive water absorption and lead to dryness and difficulty in excretion and it will be constipation. Chinese medicine, acupuncture and acupressure are the treatments of constipation in Traditional Chinese Medicine. Acupressure is a non- invasive intervention which is easy to learn and apply. We have carried out a number of studies on spinal cord injury rehabilitation support and acupressure to solve chronic problems such as constipation and anxiety. And this study aims to investigate the effects of acupressure combined with nursing intervention on constipation and quality of life in community-dwelling spinal cord injury patients.
Status | Active, not recruiting |
Enrollment | 78 |
Est. completion date | April 30, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. being Hong Kong residents between the ages of 18 or older, 2. having an SCI diagnosis for over 6 months and living in the community, 3. demonstrating the willingness and ability to learn and engage in acupressure (or having a caregiver to assist if self-operating is not feasible), 4. experiencing difficulties with defecation or having concerns related to defecation. Exclusion Criteria: 1. currently undergoing other TCM treatments or receiving interventions related to defecation or bowel functions, 2. being unable to attend the training sessions due to personal reasons, 3. having a history of gastrointestinal organic disease, 4. having severe metabolic diseases, cardiovascular, cerebrovascular, or mental illnesses |
Country | Name | City | State |
---|---|---|---|
Hong Kong | School of Nursing, The Hong Kong Polytechnic Unviersity | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The severity of constipation at baseline | Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation. | The severity of constipation will be assessed at baseline assessment. | |
Primary | The severity of constipation at post-intervention | Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation. | The severity of constipation will be assessed after 10 days intervention. | |
Primary | The severity of constipation at one month follow-up | Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation. | The severity of constipation will be assessed after one month follow-up. | |
Secondary | Quality of life at baseline | The Patient Assessment of Constipation Quality of Life Questionnaire will be used to measure the quality of life of Spinal cord injury participants. The scale investigates the quality of life of people in the past two weeks, using a 5-point Likert scale, assigning 0-4 points for various discomforts from "not at all" to "extremely". Each domain score and total score are the average scores of the domain items and all items, respectively. Higher scores indicate poorer quality of life. | Quality of life will be assessed at baseline assessment. | |
Secondary | Quality of life at post-intervention | The Patient Assessment of Constipation Quality of Life Questionnaire will be used to measure the quality of life of Spinal cord injury participants. The scale investigates the quality of life of people in the past two weeks, using a 5-point Likert scale, assigning 0-4 points for various discomforts from "not at all" to "extremely". Each domain score and total score are the average scores of the domain items and all items, respectively. Higher scores indicate poorer quality of life. | Quality of life will be assessed after 10 days intervention. | |
Secondary | Quality of life at one month follow-up | The Patient Assessment of Constipation Quality of Life Questionnaire will be used to measure the quality of life of Spinal cord injury participants. The scale investigates the quality of life of people in the past two weeks, using a 5-point Likert scale, assigning 0-4 points for various discomforts from "not at all" to "extremely". Each domain score and total score are the average scores of the domain items and all items, respectively. Higher scores indicate poorer quality of life. | Quality of life will be assessed after one month follow-up. | |
Secondary | Psychosocial well-being at baseline | The Depression Anxiety Stress Scale (DASS) will be used to measure participants' psychosocial well-being. The scale investigates the negative emotional experience or the corresponding physiological response in the last week. | Psychosocial well-being will be assessed at baseline assessment. | |
Secondary | Psychosocial well-being at post-intervention | The Depression Anxiety Stress Scale (DASS) will be used to measure participants' psychosocial well-being. The scale investigates the negative emotional experience or the corresponding physiological response in the last week. | Psychosocial well-being will be assessed after 10 days intervention. | |
Secondary | Psychosocial well-being at one month follow-up | The Depression Anxiety Stress Scale (DASS) will be used to measure participants' psychosocial well-being. The scale investigates the negative emotional experience or the corresponding physiological response in the last week. | Psychosocial well-being will be assessed after one month follow-up | |
Secondary | Bowel habit at baseline | Bowel habits will be assessed during each visit by recording the frequency of laxative and glycerine enema use, as well as the frequency and duration of defecation in the past week. | Bowel habit will be assessed at baseline assessment. | |
Secondary | Bowel habit at post-intervention | Bowel habits will be assessed during each visit by recording the frequency of laxative and glycerine enema use, as well as the frequency and duration of defecation in the past week. | Bowel habit will be assessed after 10 days intervention. | |
Secondary | Bowel habit at one month follow-up | Bowel habits will be assessed during each visit by recording the frequency of laxative and glycerine enema use, as well as the frequency and duration of defecation in the past week. | Bowel habit will be assessed after one month follow-up. |
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