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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The severity of constipation at baseline
研究概览
简要总结
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.
详细描述
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.
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
- None
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
- •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.
排除标准
- •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
结局指标
主要结局
The severity of constipation at baseline
时间窗: The 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-intervention
时间窗: The 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-up
时间窗: The 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.
次要结局
- 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.)
- Psychosocial well-being at one month follow-up(Psychosocial well-being will be assessed after one month follow-up)
- Bowel habit at baseline(Bowel habit will be assessed at baseline assessment.)
- Bowel habit at post-intervention(Bowel habit will be assessed after 10 days intervention.)
- Bowel habit at one month follow-up(Bowel habit will be assessed after one month follow-up.)