Clinical trial NCT06877078: Effect of Pre-Surgery Constipation Podcast: A RCT
Official title: The Effect of Information About Constipation Via a Podcast for Patients Prior to Planned Orthopaedic Surgery - a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constipation
Orthopedic Disorder
Keywords: podcast
patient information
constipation
orthopedic surgery
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: ROME IV Diagnostic Criteria for functional constipation
timeFrame: Measured at baseline (after preparatory consultation) and 1-3 days prior to surgery.
Secondary outcomes:
measure: The Patient Assessment of Constipation Quality of Life (PAC-QOL)
timeFrame: Measured at baseline (after preparatory consultation), 1-3 days prior to surgery, and 1 week and 4 weeks after surgery.
measure: ROME IV Diagnostic Criteria for functional constipation
timeFrame: Measured at baseline (after preparatory consultation) and 1 week and 4 weeks after surgery.
measure: Number of hospitalizations after surgery
timeFrame: 30 days and 6 months after surgery
measure: Number of contacts to general practitioner after surgery
timeFrame: 30 days and 6 months after surgery
measure: Number of outpatient visits after surgery
timeFrame: 30 days and 6 months after surgery
Other outcomes:
measure: Use of podcast and information material, and the usefulness of these.
timeFrame: Measured 1-3 days prior to surgery, and at 1 week and 4 weeks after surgery.
measure: Use of laxantia, frequency (regularly or as needed) and type.
timeFrame: Measured at baseline, 1-3 days prior to surgery, and at 1 week and 4 weeks after surgery.
measure: Days of hospitalization after surgery
timeFrame: From time for admission to surgery to discharge
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
Study officials:
affiliation: Regional Hospital Central Jutland, Medical Diagnostic Centre
name: Charlotte Weiling Appel, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References: