Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06877078

The Effect of Information About Constipation Via a Podcast for Patients Prior to Planned Orthopaedic Surgery - a Randomised Controlled Trial.

Led by Central Jutland Regional Hospital · Updated on 2025-05-08

600

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of a podcast about constipation on patients undergoing planned orthopedic surgeries such as knee, hip, shoulder, and back operations. This randomized controlled trial aims to see if the podcast can reduce the number of patients experiencing constipation before and after surgery. The study includes adults 18 years or older who can use digital devices and do not have certain gastrointestinal conditions or severe hearing or cognitive impairments. Participants will be randomly assigned to either a control group or an intervention group. Both groups receive standard preoperative information, but the intervention group also gets access to a 30-minute podcast featuring expert explanations and patient experiences related to constipation around surgery. The podcast is accessible throughout the study period. Data will be collected through online questionnaires at four points: after the preoperative consultation, shortly before surgery, one week after surgery, and four weeks after surgery. During the study, participants will complete questionnaires assessing constipation using the ROME IV Diagnostic Criteria and quality of life related to constipation via the PAC-QOL tool. Additional information will be gathered about laxative use, educational and living situations, and healthcare contacts from patient records. The researchers will monitor hospitalizations, outpatient visits, and general practitioner contacts up to six months after surgery to evaluate the overall impact. Participation lasts from pre-surgery consultation through four weeks after surgery, with some data extending to six months post-surgery.

CONDITIONS

Brief Title

Effect of Pre-Surgery Constipation Podcast: A RCT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at the preoperative consultation

Treatment

Duration - 2 to 6 weeks before surgery

Participants receive standard pre-surgery information; those in the intervention group also listen to a 30-minute podcast about constipation related to surgery.

1 baseline visit after preoperative consultation and 1 visit 1-3 days before surgery

Post-operative Follow-up

Duration - 4 weeks after surgery

Participants complete online questionnaires to monitor constipation and quality of life after surgery.

2 online questionnaire assessments at 1 week and 4 weeks after surgery

Trial Site Locations

Total: 1 location

1

Silkeborg Regional Hospital

Silkeborg, Denmark, 8600

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Research Team

C

Charlotte Weiling Appel, Ph.d.

A

Anne Mette Schmidt, Ph.d.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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