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Effect of Acupressure on Constipation in Community-dwelling Spinal Cord Injury Patients: a Randomized Controlled Trial

Not Applicable
Completed
Conditions
Spinal Cord Injuries
Traditional Chinese Medicine
Interventions
Other: Home-based, manual light touch of the abdomen combined with nursing education
Other: Home-based, acupressure combined with nursing education
Registration Number
NCT05558657
Lead Sponsor
The Hong Kong Polytechnic University
Brief Summary

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.

Detailed Description

This study will use an open-label, double-group, randomized controlled trial to compare the effect of the intervention group with the control group. Study participants will be recruited from the "Hong Kong Direction Association for the Handicapped, a non-governmental organization dedicated to serving severely disabled Hong Kong people such as SCI. The sociodemographic data, disease status and outcome indicators of the study subjects were measured before the intervention, after the intervention and one month after the intervention. Research assistants (RA1) were trained to evaluate data and data, blinded to group assignments.

We will have the focus group interviews (semi-structured) with participants after the the intervention (post-intervention). The interviews will be conducted online to further understand the benefits and limitations of the research intervention.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control group: Home-based sham group , acupressure combined with nursing interventionsHome-based, manual light touch of the abdomen combined with nursing educationThe control group will receive home-based, manual light touch of the abdomen combined with nursing education.
Intervention groupHome-based, acupressure combined with nursing educationThe intervention group will receive home-based acupressure and nursing education.
Primary Outcome Measures
NameTimeMethod
The severity of constipation at baselineThe severity of constipation will be assessed at baseline assessment.

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 at post-interventionThe severity of constipation will be assessed after 10 days 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 at one month follow-upThe severity of constipation will be assessed after 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.

Secondary Outcome Measures
NameTimeMethod
Quality of life at baselineQuality of life will be assessed at baseline assessment.

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 at post-interventionQuality of life will be assessed after 10 days 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 at one month follow-upQuality of life will be assessed after 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.

Psychosocial well-being at baselinePsychosocial well-being will be assessed at baseline assessment.

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 at post-interventionPsychosocial well-being will be assessed after 10 days 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 at one month follow-upPsychosocial well-being will be assessed after 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.

Bowel habit at baselineBowel habit will be assessed at baseline assessment.

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 at post-interventionBowel habit will be assessed after 10 days 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 at one month follow-upBowel habit will be assessed after 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.

Trial Locations

Locations (1)

School of Nursing, The Hong Kong Polytechnic Unviersity

🇭🇰

Hong Kong, Hong Kong

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