Orthopedic SurgeryNEUPANONCT03428035
The Impact of a Neutral Formulated and Designed Package Insert on Nocebo-effect.
A study testing Package Insert in people with Orthopedic Surgery, run by University of Witten/Herdecke at 1 site in Germany.
Trial summary
Background The nocebo effect describes the association between the expectation of negative effects, (e.g. side effects) and the actual occurrence of negative effects. Studies have shown that the nocebo effect can be influenced by (risk) communication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- Package Insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- elective orthopaedic surgery
- planned intake of ibuprofen 600 mg to treat postoperative pain
- postoperative pain medication other than Ibuprofen 600 (Opioids, Opiate, Paracetamol) no longer than 1-2 days postoperative (until discharge)
- at least 18 years
- able to speak German
- no cognitive deficits
- written informed consent
Who cannot join
- serious comorbidity
- pain medication prior to surgery
- other medication with similar side effects
- polytrauma
- planned inpatient rehabilitation > one week after hospital discharge
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim
Cologne, North-Rhine-Westfalia, 51109
About this study
Official title: Neutral Formulated and Designed Package Insert or Only Verbal Information Compared to Package Insert According EU-directive: a Pilot Randomised Controlled Trial to Analyse the Influence on the Nocebo Effect and Non-adherence
Background The nocebo effect describes the association between the expectation of negative effects, (e.g. side effects) and the actual occurrence of negative effects. Studies have shown that the nocebo effect can be influenced by (risk) communication. Till today there is no study that compares different types of information on adverse events regarding the strength of the nocebo effect.
Aim The aim of this pilot randomized controlled trial is to analyse the influence of different communication types on the frequency and intensity of adverse events and adherence. To increase the relevance and applicability of the results the study intervention builds up on package inserts because these are the most widespread form of information on side effects.
Read more
Methods Patients It is planned to include 60 patients in the study.
Intervention
- Modified package insert: simplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements.
- Verbal information about side effects: The patient is informed verbally about side effects and does not receive any package insert.
Control Package insert according to EU (European Union) Directive 2001/83 / EC (European Commission) (usual package insert).
Outcomes
- Number of patient reported adverse events (primary outcome).
- Adherence (correct initiation of therapy, correct intake amount, premature discontinuation of therapy).
- Resource use (e.g. provider contacts).
Type of study Monocentric, outcome assessor, three-arm, randomised controlled pilot trial.
- Conditions
- Orthopedic Surgery
- Being tested
- Package Insert
- Keywords
- Randomized controlled trial, package insert, nocebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Package InsertOther
Also called Patient Education
Modified package insert of Ibuprofen given postprocedural as pain medication
| Study group | Role | What they receive |
|---|---|---|
| Modified Package Insert | Experimental | Simplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements. Receives: Other: Package Insert |
| Verbal Information | No intervention | The patient is informed verbally about side effects and does not receive any package insert. |
| Control | Active comparator | Package insert according to EU Directive 2001/83 / EC (usual package insert) Receives: Other: Package Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient reported adverse events
Any reported adverse events
Measured: 6-9 days after surgery
Secondary outcomes (2)
Adherence
Correct initiation of therapy, correct intake amount, premature discontinuation of therapy
Measured: 6-9 days after surgery
Resource use
e.g. provider contacts
Measured: 6-9 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Apr 2018
- Primary completion30 Sep 2018
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic SurgeryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Tim Mathes, University of Witten/Herdecke
- Investigators
- Tim Mathes, Dr., Principal investigator, Witten/Herdecke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428035
- Sponsor's protocol ID
- V01-01
- Acronym
- NEUPANO
- Status last verified
- Oct 2018
- First submitted
- 2 Feb 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and clinical study report will be shared as supplement with the journal publication
Publications
Prediger B, Meyer E, Buchter R, Mathes T. Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial. Trials. 2019 Jul 26;20(1):458. doi: 10.1186/s13063-019-3565-3.
PubMed 31349865
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutral Formulated and Designed Package Insert or Only Verbal Information Compared to Package Insert According EU-directive: a Pilot Randomised Controlled Trial to Analyse the Influence on the Nocebo Effect and Non-adherence
- ClinicalTrials.gov ID
- NCT03428035
- Acronym / sponsor ID
- NEUPANO / V01-01
- Conditions
- Orthopedic Surgery
- Keywords
- Randomized controlled trial, package insert, nocebo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 Feb 2018 (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.
Background The nocebo effect describes the association between the expectation of negative effects, (e.g. side effects) and the actual occurrence of negative effects. Studies have shown that the nocebo effect can be influenced by (risk) communication. Till today there is no study that compares different types of information on adverse events regarding the strength of the nocebo effect.
Aim The aim of this pilot randomized controlled trial is to analyse the influence of different communication types on the frequency and intensity of adverse events and adherence. To increase the relevance and applicability of the results the study intervention builds up on package inserts because these are the most widespread form of information on side effects.
Methods Patients It is planned to include 60 patients in the study.
Intervention
- Modified package insert: simplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements.
- Verbal information about side effects: The patient is informed verbally about side effects and does not receive any package insert.
Control Package insert according to EU (European Union) Directive 2001/83 / EC (European Commission) (usual package insert).
Outcomes
- Number of patient reported adverse events (primary outcome).
- Adherence (correct initiation of therapy, correct intake amount, premature discontinuation of therapy).
- Resource use (e.g. provider contacts).
Type of study Monocentric, outcome assessor, three-arm, randomised controlled pilot trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Modified Package Insert | Experimental | Other: Package InsertSimplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements. |
| Verbal Information | No intervention | –The patient is informed verbally about side effects and does not receive any package insert. |
| Control | Active comparator | Other: Package InsertPackage insert according to EU Directive 2001/83 / EC (usual package insert) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- elective orthopaedic surgery
- planned intake of ibuprofen 600 mg to treat postoperative pain
- postoperative pain medication other than Ibuprofen 600 (Opioids, Opiate, Paracetamol) no longer than 1-2 days postoperative (until discharge)
- at least 18 years
- able to speak German
Key exclusion criteria (5 listed)
- serious comorbidity
- pain medication prior to surgery
- other medication with similar side effects
- polytrauma
- planned inpatient rehabilitation > one week after hospital discharge
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 |
|---|---|---|
| Package InsertAlso: Patient EducationModified package insert of Ibuprofen given postprocedural as pain medication | Other | Control, Modified Package Insert |
Primary outcome
Number of patient reported adverse events
Time frame: 6-9 days after surgery
Any reported adverse events
2 secondary outcomes
Adherence
Time frame: 6-9 days after surgery
Resource use
Time frame: 6-9 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 31349865Prediger B, Meyer E, Buchter R, Mathes T. Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial. Trials. 2019 Jul 26;20(1):458. doi: 10.1186/s13063-019-3565-3.
- Individual participant dataSharing planned: Yes. Study protocol and clinical study report will be shared as supplement with the journal publication
Related trials for Orthopedic Surgery
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PPP Versus Corticosteroid for Thigh Muscle Injuries
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Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
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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. This study is not recruiting at the moment.
Tim Mathes, Dr. principal investigator
Witten/Herdecke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Package Insert in people with Orthopedic Surgery, run by University of Witten/Herdecke at 1 site in Germany.
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 7 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient reported adverse events (time frame: 6-9 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03428035, which also lists 1 linked publication.
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 9 Oct 2018.