Effect of Pre-Surgery Constipation Podcast: A RCT

NCT06877078 | Recruiting

• 1 other identifier: 1-16-02-6-25
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Orthopedic Disorder

Keywords

podcast; patient information; constipation; orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• ROME IV Diagnostic Criteria for functional constipation

  The ROME IV criteria consists of 6 diagnostic criteria. To diagnose constipation using ROME IV criteria in this study, two or more of the criteria must have been fulfilled the last 3 months or since last measured.

  Measured at baseline (after preparatory consultation) and 1-3 days prior to surgery.

Secondary Outcomes (5)

• The Patient Assessment of Constipation Quality of Life (PAC-QOL)

  Measured at baseline (after preparatory consultation), 1-3 days prior to surgery, and 1 week and 4 weeks after surgery.

• ROME IV Diagnostic Criteria for functional constipation

  Measured at baseline (after preparatory consultation) and 1 week and 4 weeks after surgery.

• Number of hospitalizations after surgery

  30 days and 6 months after surgery

• Number of contacts to general practitioner after surgery

  30 days and 6 months after surgery

• Number of outpatient visits after surgery

  30 days and 6 months after surgery

Other Outcomes (3)

• Use of podcast and information material, and the usefulness of these.

  Measured 1-3 days prior to surgery, and at 1 week and 4 weeks after surgery.

• Use of laxantia, frequency (regularly or as needed) and type.

  Measured at baseline, 1-3 days prior to surgery, and at 1 week and 4 weeks after surgery.

• Days of hospitalization after surgery

  From time for admission to surgery to discharge

Study Arms (2)

Podcast Group

EXPERIMENTAL

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.

Behavioral: Constipation information via Podcast

Control Group

NO INTERVENTION

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.

Interventions

Constipation information via Podcast BEHAVIORAL

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.

Podcast Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

RECRUITING

MeSH Terms

Conditions

Constipation; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlotte Weiling Appel, Ph.d.

  Regional Hospital Central Jutland, Medical Diagnostic Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Weiling Appel, Ph.d.

CONTACT

+45 61263630; chaapp@rm.dk

Anne Mette Schmidt, Ph.d.

CONTACT

anne.mette.schmidt@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients cannot be blinded to whether they receive access to the podcast but will be blinded to the study hypothesis. They will be informed that the study compares two types of preoperative information on constipation. Staff involved in recruitment will be blinded to randomisation, which will be carried out using the secure online system REDCap, and researchers conducting the analyses will remain blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research nurse

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 14, 2025
• Study Start: April 1, 2025
• Primary Completion: October 17, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)