Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
600 participants
INTERVENTIONAL
2025-04-01
2027-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Technology-based Constipation Prevention Training
NCT06234865
Prevention of Constipation: Systematic Nursing Interventions to Reduce Postoperative Constipation After Thoracic Surgery
NCT00364169
Ear Massage Effect on Bowel Activity After Surgery
NCT06862986
Effect of Preoperative Abdominal Effleurage on Postoperative Constipation
NCT07344532
Evaluation of a Preoperative Education Class for Colorectal Surgery Patients
NCT03237897
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Constipation information via Podcast
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 collaboration with Silkeborg Regional Hospital and the Central Denmark Region's Centre for Competence Development.
Patients will get access to the podcast after randomisation, and will be able to listen to it throughout the study period.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Constipation information via Podcast
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 collaboration with Silkeborg Regional Hospital and the Central Denmark Region's Centre for Competence Development.
Patients will get access to the podcast after randomisation, and will be able to listen to it throughout the study period.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Central Jutland Regional Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Charlotte Appel
Research nurse
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charlotte Weiling Appel, Ph.d.
Role: PRINCIPAL_INVESTIGATOR
Regional Hospital Central Jutland, Medical Diagnostic Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Silkeborg Regional Hospital
Silkeborg, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1-16-02-6-25
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.