NCT06877078 Effect of Pre-Surgery Constipation Podcast: A RCT
| NCT ID | NCT06877078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Jutland Regional Hospital |
| Condition | Constipation |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2025-10-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-04-01 with a primary completion date of 2025-10-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Charlotte Weiling Appel, Ph.d.
PRINCIPAL INVESTIGATOR
Regional Hospital Central Jutland, Medical Diagnostic Centre
Frequently Asked Questions
Who can join the NCT06877078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Constipation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06877078 currently recruiting?
Yes, NCT06877078 is actively recruiting participants. Contact the research team at chaapp@rm.dk for enrollment information.
Where is the NCT06877078 trial being conducted?
This trial is being conducted at Silkeborg, Denmark.
Who is sponsoring the NCT06877078 clinical trial?
NCT06877078 is sponsored by Central Jutland Regional Hospital. The principal investigator is Charlotte Weiling Appel, Ph.d. at Regional Hospital Central Jutland, Medical Diagnostic Centre. The trial plans to enroll 600 participants.