The Effect of Information About Constipation Via a Podcast for Patients Prior to Planned Orthopaedic Surgery - a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- ROME IV Diagnostic Criteria for functional constipation
研究概览
简要总结
In this study, the investigators will evaluate the effect of a podcast on constipation on the number of patients with constipation. It is hypothesised that the podcast on constipation, will prevent constipation in the period leading up to and after surgery.
This is a randomised controlled trial. The population of the study will consist of patients with planned orthopaedic surgery (knee, hip, shoulder, and back) at the Elective Surgery Centre, Silkeborg Regional Hospital. The sample of the study will consist of patients 18 years or older, who are able to understand, read and write Danish, has an email address, has access to and is able to navigate a computer, tablet or smartphone, does not have severe hearing loss, does not have cognitive dysfunction or other mental illness that would make participation difficult, is not participating in other trials at the Elective Surgery Centre, is not diagnosed with a gastrointestinal condition (Crohns, Colitis ulcerosa or celiac disease), and does not previously have received a colostomy or ileostomy.
Patients will be randomised to either a control group or an intervention group. Both groups will receive the standard information at the preoperative consultation and after randomisation. The intervention group will also receive a podcast.
The study will collect data using an online questionnaire, that includes The ROME IV Diagnostic Criteria for functional constipation and "The Patient Assessment of Constipation Quality of Life (PAC-QOL)". Data will be collected at 4 times: (1) after the preoperative consultation (baseline), (2) 1-2 days prior to surgery, (3) 1 week after surgery, and (4) 4 weeks after surgery.
详细描述
Objective:
Primary aim: to evaluate the effect of a podcast on the number of patients with constipation at admission to surgery.
Secondary aim: to evaluate the effect of a podcast on the number of patients with constipation in the period after surgery.
Method: This is a randomised controlled trial, which will be conducted at the Silkeborg Regional Hospital, Denmark, between March and October 2025.
The study population will include patients scheduled for knee, hip, shoulder, and back surgery at the Elective Surgery Centre, Silkeborg Regional Hospital. The study population will consist of patients 18 years or older, who are able to understand, read and write Danish, has an email address, has access to and is able to navigate a computer, tablet or smartphone, does not have severe hearing loss, does not have cognitive dysfunction or other mental illness that would make participation difficult, is not participating in other trials at the Elective Surgery Centre, is not diagnosed with a gastrointestinal condition (Crohns, Colitis ulcerosa or celiac disease), and does not previously have received a colostomy or ileostomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Patients cannot be blinded to whether they receive access to the podcast but will be blinded to the study hypothesis. They will be informed that the study compares two types of preoperative information on constipation. Staff involved in recruitment will be blinded to randomisation, which will be carried out using the secure online system REDCap, and researchers conducting the analyses will remain blinded.
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
- •Is 18 years or older.
- •Has a scheduled back, shoulder, knee, or hip operation at the Elective Surgery Centre
- •Is able to read, speak and understand Danish.
- •Has an email address and gives consent to contact via email
- •Has access to and is able to navigate a computer, tablet or smartphone
排除标准
- •Is unable to listen to the podcast, due to severe hearing loss.
- •Is affected by cognitive dysfunction or mental illness that makes participation difficult.
- •Is participating in other trials at the Elective Surgery Centre.
- •Is diagnosed with a gastrointestinal condition, this being Crohns, Colitis ulcerosa, or celiac disease.
- •Has previously received a colostomy or ileostomy.
研究组 & 干预措施
Podcast Group
Participants in the experimental group will in addition to the standard information also receive a podcast.
The standard information is provided by a nurse at the preoperative consultation. Patients also receive a card with access to an online platform with information about constipation, the specific surgery, preparations for surgery, and the period after surgery.
干预措施: Constipation information via Podcast (Behavioral)
Control Group
Participants in the control group will receive the standard information. The information is provided by a nurse at the preoperative consultation. Patients also receive a card with access to an online platform with information about constipation, the specific surgery, preparations for surgery, and the period after surgery.
结局指标
主要结局
ROME IV Diagnostic Criteria for functional constipation
时间窗: Measured at baseline (after preparatory consultation) and 1-3 days prior to surgery.
The ROME IV criteria consists of 6 diagnostic criteria. To diagnose constipation using ROME IV criteria in this study, two or more of the criteria must have been fulfilled the last 3 months or since last measured.
次要结局
- The Patient Assessment of Constipation Quality of Life (PAC-QOL)(Measured at baseline (after preparatory consultation), 1-3 days prior to surgery, and 1 week and 4 weeks after surgery.)
- ROME IV Diagnostic Criteria for functional constipation(Measured at baseline (after preparatory consultation) and 1 week and 4 weeks after surgery.)
- Number of hospitalizations after surgery(30 days and 6 months after surgery)
- Number of contacts to general practitioner after surgery(30 days and 6 months after surgery)
- Number of outpatient visits after surgery(30 days and 6 months after surgery)
研究者
Charlotte Appel
Research nurse
Central Jutland Regional Hospital