Effect of Acupressure on Constipation in Community-dwelling Spinal Cord Injury Patients: a Randomized Controlled Trial
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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2022
CompletedFirst Posted
Study publicly available on registry
September 28, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedOctober 10, 2024
September 1, 2024
1.6 years
September 6, 2022
October 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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 Outcomes (9)
Quality of life at baseline
Quality of life will be assessed at baseline assessment.
Quality of life at post-intervention
Quality of life will be assessed after 10 days intervention.
Quality of life at one month follow-up
Quality of life will be assessed after one month follow-up.
Psychosocial well-being at baseline
Psychosocial well-being will be assessed at baseline assessment.
Psychosocial well-being at post-intervention
Psychosocial well-being will be assessed after 10 days intervention.
- +4 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALThe intervention group will receive home-based acupressure and nursing education.
Control group: Home-based sham group , acupressure combined with nursing interventions
ACTIVE COMPARATORThe control group will receive home-based, manual light touch of the abdomen combined with nursing education.
Interventions
The intervention group will focus on 11 acupoints on the abdomen (RN12, RN4, ST25), back (BL20, BL21, BL22, BL23, BL24, BL25), and limbs (LI4, ST36). The participants or their caregivers can perform acupressure 30 minutes after meals and twice a day. Participants can choose between two sets of acupressure: (1) Acupressure of the abdominal and back acupoints in a seated position, or (2) Acupressure of the abdominal and limb acupoints in a supine position. Each session lasts approximately 15 minutes. Besides, the intervention group will also receive nursing education on the basis of receiving acupressure intervention including (1) dietary guidance: help patients to formulate a reasonable diet plan, (2) cultivate regular defecation habits, (3) understand appropriate defecation environments and postures, and (4) Moderate exercise to increase gastrointestinal motility.
Control group or their caregivers will apply the manual light touch to the abdomen in any direction or body position at home. In keeping consistent with the intervention group, abdomen touching will also be administered twice daily for approximately 15 minutes each for 10 days. Participants will also receive nursing education.
Eligibility Criteria
You may qualify if:
- being Hong Kong residents between the ages of 18 or older,
- having an SCI diagnosis for over 6 months and living in the community,
- demonstrating the willingness and ability to learn and engage in acupressure (or having a caregiver to assist if self-operating is not feasible),
- experiencing difficulties with defecation or having concerns related to defecation.
You may not qualify if:
- currently undergoing other TCM treatments or receiving interventions related to defecation or bowel functions,
- being unable to attend the training sessions due to personal reasons,
- having a history of gastrointestinal organic disease,
- having severe metabolic diseases, cardiovascular, cerebrovascular, or mental illnesses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Nursing, The Hong Kong Polytechnic Unviersity
Hong Kong, Hong Kong
Related Publications (36)
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PMID: 40846520DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Li, Dr
School of Nursing, The Hong Kong Polytechnic University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2022
First Posted
September 28, 2022
Study Start
March 1, 2023
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
October 10, 2024
Record last verified: 2024-09