ConstipationNCT06877078
Effect of Pre-Surgery Constipation Podcast: A RCT
A study testing Constipation information via Podcast in people with Constipation and Orthopedic Disorder, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Orthopedic Disorder
- What is being tested?
- Constipation information via Podcast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne Mette Schmidt, Ph.d. contact
Denmark1 site, 1 recruiting
- Recruiting
Silkeborg Regional Hospital
Silkeborg, 8600
About this study
Official title: The Effect of Information About Constipation Via a Podcast for Patients Prior to Planned Orthopaedic Surgery - a Randomised Controlled Trial.
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.
Read more
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.
Read the 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.
- Conditions
- Constipation, Orthopedic Disorder
- Being tested
- Constipation information via Podcast
- Keywords
- podcast, patient information, constipation, orthopedic surgery
- Medical subject headings
- Constipation, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constipation information via PodcastBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
The Patient Assessment of Constipation Quality of Life is a questionnaire that measures quality of life of patients with constipation. It contains 28 items grouped into 4 subscales covering: Worries and concerns (11 items), Physical discomfort (4 items), Psychosocial discomfort (8 items), and Satisfaction (5 items). A 5-point Likert response scale, ranging from 0 (Not at all / None of the time) to 4 (Extremely / All of the time), is used over a 2-week recall period. Minimum score: 0 (none of the time), maximum score 112 (all of the time/extremely).
Measured: 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
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: Measured at baseline (after preparatory consultation) and 1 week and 4 weeks after surgery.
Number of hospitalizations after surgery
Number of hospitalizations after surgery
Measured: 30 days and 6 months after surgery
Number of contacts to general practitioner after surgery
Number of contacts to general practitioner after surgery
Measured: 30 days and 6 months after surgery
Number of outpatient visits after surgery
Number of outpatient visits after surgery (all and contact to surgery department and gastroenterology department)
Measured: 30 days and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Apr 2025
- Primary completion17 Oct 2025 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Appel, Central Jutland Regional Hospital
- Investigators
- Charlotte Weiling Appel, Ph.d., Principal investigator, Regional Hospital Central Jutland, Medical Diagnostic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877078
- Sponsor's protocol ID
- 1-16-02-6-25
- Status last verified
- May 2025
- First submitted
- 7 Mar 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Information About Constipation Via a Podcast for Patients Prior to Planned Orthopaedic Surgery - a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06877078
- Acronym / sponsor ID
- 1-16-02-6-25
- Conditions
- Constipation, Orthopedic Disorder
- Keywords
- podcast, patient information, constipation, orthopedic surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 17 Oct 2025 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Podcast Group | Experimental | Behavioral: Constipation information via PodcastParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constipation information via PodcastThe 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. | Behavioural | Podcast Group |
Primary outcome
ROME IV Diagnostic Criteria for functional constipation
Time frame: Measured at baseline (after preparatory consultation) and 1-3 days prior to surgery.
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.
5 secondary outcomes
The Patient Assessment of Constipation Quality of Life (PAC-QOL)
Time frame: 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
Time frame: Measured at baseline (after preparatory consultation) and 1 week and 4 weeks after surgery.
Number of hospitalizations after surgery
Time frame: 30 days and 6 months after surgery
Number of contacts to general practitioner after surgery
Time frame: 30 days and 6 months after surgery
Number of outpatient visits after surgery
Time frame: 30 days and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Mette Schmidt, Ph.d. contact
Charlotte Weiling Appel, Ph.d. principal investigator
Regional Hospital Central Jutland, Medical Diagnostic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constipation information via Podcast in people with Constipation and Orthopedic Disorder, run by Central Jutland Regional Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Weiling Appel, Ph.d. (+45 61263630, chaapp@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROME IV Diagnostic Criteria for functional constipation (time frame: Measured at baseline (after preparatory consultation) and 1-3 days prior to surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.