Effect of Pre-Surgery Constipation Podcast: A RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Jutland Regional Hospital
About this 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.
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Constipation information via Podcast
BehavioralThe 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Podcast GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Measured at baseline (after preparatory consultation) and 1-3 days prior to surgery.Secondary outcomes
1
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).
Time frame
Measured at baseline (after preparatory consultation), 1-3 days prior to surgery, and 1 week and 4 weeks after surgery.2
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.
Time frame
Measured at baseline (after preparatory consultation) and 1 week and 4 weeks after surgery.3
Number of hospitalizations after surgery
Number of hospitalizations after surgery
Time frame
30 days and 6 months after surgery4
Number of contacts to general practitioner after surgery
Number of contacts to general practitioner after surgery
Time frame
30 days and 6 months after surgeryOther outcomes
1
Use of podcast and information material, and the usefulness of these.
In the online questionnaire, all patients will be asked about their use of the information an if they found it useful. The intervention group will also be asked if they have listened to the podcast, and if they found it useful.
Time frame
Measured 1-3 days prior to surgery, and at 1 week and 4 weeks after surgery.2
Use of laxantia, frequency (regularly or as needed) and type.
In the online questionnaire patients will be asked whether they use laxantia, and if so what type and how often (regularly or as needed).
Time frame
Measured at baseline, 1-3 days prior to surgery, and at 1 week and 4 weeks after surgery.3
Days of hospitalization after surgery
Days of hospitalization after surgery
Time frame
From time for admission to surgery to dischargeSponsors and contacts
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Source ClinicalTrials.gov