Effect of Pre-Surgery Constipation Podcast: A RCT

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.

Sample size: Based on calculations, 600 patients are needed to achieve 80% power at a 5% significance level, assuming 30% constipation in the control group and 10 percentage points fewer in the intervention group (ROME IV criteria).

Eligible participants will be randomised into a control group and an intervention group. Both groups will receive the standard information related to their respective surgeries. The intervention group will however also be receiving a podcast about constipation in relation to surgery. The podcast is 30 minutes long, and includes information on constipation explained by a gastroenterologist specialised in defecation disorders, as well as patients' experience with constipation after surgery. The podcast is developed in a collaboration between Elective Surgery Centre, Medical Diagnostic Centre (Silkeborg Regional Hospital) and the Central Denmark Region's Centre for Competence Development.

The outcomes are measured using online questionnaires at (1) baseline after preoperative consultation (2-6 weeks before surgery), (2) 1-3 days before surgery, (3) 1 week after surgery, and (4) 4 weeks after surgery. Primary and secondary outcome is the prevalence of constipation measured using questionnaires with ROME IV criteria. Questionnaires will also be used to collect data on quality of life (The Patient Assessment of Constipation Quality of Life (PAC-QOL)), use of laxatives (frequency and type), education level, employment, living situation, use of the standard patient information and its usefulness, and use of the podcast and its usefulness. Data will also be collected from patient records using The Region of Central Denmark's data warehouse. This will be data on hospitalisations and length of stay, rehospitalisation, type of surgery, diagnoses, contact with general practitioner, and contact with the clinic due to issues with bowel movements.

Inclusion criteria

• 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

Exclusion criteria

• 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.