Cancer of ColonMU-PRIORNCT05982184
Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery
A study testing Music in people with Cancer of Colon and Surgery, run by Erasmus Medical Center at 5 sites in Netherlands.
Trial summary
The goal of this multicenter randomized controlled trial is to investigate the effect of music prehabilitation on preoperative anxiety in patients undergoing elective oncological colorectal resection. Patients will be asked to listen to music three times a day starting one week before day of surgery. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer of Colon, Surgery, Anxiety
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 5 sitesNetherlands
- Study dates
- 3 Oct 2023to 12 Dec 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged ≥ 16 years
- Patients undergoing elective oncological colorectal surgery at participating center
- Minimal hospital stay of 2 days postoperatively.
- Sufficient knowledge of the Dutch language
- Communicable and able to assess the questionnaires
- Patients who have access to personal music playing device and headphones/earphones. - Written informed consent acquired from the patient
Who cannot join
- Patients with severe hearing impairment (defined as no or barely verbal communication possible).
- Patients with an expected stay of less than two nights in the hospital
- Patients who are professional musicians.
- Active music players or singers who may play or sing every week
- Patients who actively listen to music with a duration of > 30 minutes daily. Active listening is defined as music listening with headphones/earphones, while this is not combined with any other activity (e.g. exercising, working, driving or religious activities).
- Patients who have a preoperative waiting period of less than five days.
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- Participation in another study that may possibly intervene with the outcome measures. (e.g. use of psychiatric medication during inclusion or prehabilitation interventions or similar procedures according to the judgement of the research team)
- Assessment of primary outcome is not possible.
- Patients with mental disorders influencing their ability to adhere to the study protocol and/or assess the questionnaires.
- Inability or unwillingness to receive the music intervention.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Amphia Ziekenhuis
Breda, North Brabant
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, 3318 AT
Admiraal de Ruyter Ziekenhuis
Goes, Zeeland
Franciscus Gasthuis
Rotterdam, South Holland, 3045 PM
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079 DZ
About this study
Official title: Effect of Music Prehabilitation on Preoperative Anxiety in Patients Undergoing Colorectal Oncological Resection: a Multicentre Randomized Controlled Trial
The goal of this multicenter randomized controlled trial is to investigate the effect of music prehabilitation on preoperative anxiety in patients undergoing elective oncological colorectal resection. Patients will be asked to listen to music three times a day starting one week before day of surgery. Anxiety levels will be compared with the control group that is not explicitly instructed to listen to music by using validated questionnaires
Read the detailed description
Perioperative music interventions have been proven to have a positive effect on surgical patients regarding postoperative pain, anxiety and stress. Preoperative anxiety is a predictor for postoperative pain. It is hypothesized that preoperative anxiety develops at home. Unfortunately, data on this subject is scarce. Prehabilitation is a relatively new concept, which improves the patient's condition at home waiting for a surgical intervention. No studies exist in which music is implemented as a prehabilitation method. Music interventions are relatively simple low cost, sustainable and know no side effects. The researchers hypothesize that the use of pre-admittance music interventions as a prehabilitation modality in oncological colorectal surgical patients will decrease preoperative anxiety.
- Conditions
- Cancer of Colon, Surgery, Anxiety
- Being tested
- Music
- Keywords
- Music, Colon cancer, Surgery, Anxiety, Perioperative care, Prehabilitation, Non pharmacological intervention
- Medical subject headings
- Colonic Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Also called Music medicine, music intervention
Patient preferred music listened to through earpieces or headphones using patients' own hardware and software.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Music intervention at home. Patients will be asked to listen to music using their own equipment three times a day. Starting approximately a week prior to surgery up to the day of surgery. Receives: Other: Music |
| Standard Care | No intervention | Treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission.
The STAI-6 questionnaire is a validated and frequently used six item questionnaire to assess anxiety. Six questions regarding feelings of anxiety are scored on a four point Likert scale. Scoring is achieved by reverse scoring of the positive items, sum all six scores, and multiplying the score by 20 divided by 6. The score ranges between 20 and 80, in which a higher score correlates with a higher anxiety level.
Measured: Baseline and day of admittance to hospital
Secondary outcomes (9)
Patient reported pain on a 1-10 numeric scale.
Pain scores are gathered thrice daily by nurses as part of standard care
Measured: Thrice daily on each post-operative day until discharge
Incidence of delirium diagnosis made by geriatricians or psychiatrists
Diagnosis of delirium by geriatricians or psychiatrists as noted in the electronic health report were considered as a confirmed diagnosis of delirium
Measured: Post-operative until discharge
Delirium observation scale scores (DOS).
The DOS is a 13-point screen for delirium, based on Diagnostic and statistical manual of mental disorders version 4 (DSM-IV) delirium criteria, designed to be completed by a nurse. Responses are dichotomous. Scores ≥ 3 were considered positive delirium screens.
Measured: Post-operative until discharge
Subjective stress, measured with the 10-item perceived stress scale (PSS-10) questionnaire at baseline, day of admittance and at discharge.
The PSS-10 is a validated questionnaire which assess subjective stress. It is a 10-item, comprehensive, reliable and valid instrument which is created and validated in the American population and widely used in medical/psychological studies. The items are each scored on a five-point Likert scale (ranging from 0 = never to 4 = very often). A Dutch translation of the PSS-10 was created according to the principles of good translation (the existing English version was translated to Dutch by a native Dutch speaker, afterwards the translated Dutch version was compared to the original validated English version by a native English speaker)(
Measured: Baseline, day of admittance and discharge
Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire.
The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: 30 days postoperatively
Rate, timing and total dosages of medication given to the patient (sedatives, analgetics etc.)
Every medication and dose provided to the patient is recorded in the EHR and will be extracted to assess possible differences in medication requirements between intervention and control group
Measured: From admission to discharge
A self-made questionnaire assessing patient satisfaction regarding music intervention
A 5-item questionnaire comprised of dichotomous and open ended questions regarding the patients satisfaction with the music intervention.
Measured: 4 weeks postoperatively at follow-up
Rate of complications
Complication documentation as provided my medical staff and associated Clavien-Dindo score
Measured: Postoperatively until 30 days follow-up
Quality of recovery is a comprehensive 40-item questionnaire (QoR-40) used to assess the rate of recovery after surgery.
The quality of recovery will be assessed using de QoR-40 questionnaire, assessed at 30 days postoperatively. This is a questionnaire which assesses five subscales, including emotional state, physical independence, psychological support, pain and physical comfort. The questionnaire uses a five-point Likert scale.
Measured: 4 weeks postoperatively at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start3 Oct 2023
- Primary completion22 Nov 2025
- Study completion12 Dec 2025
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 Cancer of ColonStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Klimek, Erasmus Medical Center
- Investigators
- Markus Klimek, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982184
- Sponsor's protocol ID
- 9411
- Acronym
- MU-PRIOR
- Status last verified
- Dec 2025
- First submitted
- 14 Jul 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verhoeven JG, Geensen R, Dirven TLA, Rietdijk WJR, Birnie E, Jeekel J, Klimek M. Study protocol for a multicentre randomised controlled trial using music prehabilitation to reduce preoperative anxiety before oncological colorectal surgery: the MU-PRIOR trial. BMJ Open. 2025 Apr 29;15(4):e095239. doi: 10.1136/bmjopen-2024-095239.
PubMed 40306915
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Prehabilitation on Preoperative Anxiety in Patients Undergoing Colorectal Oncological Resection: a Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05982184
- Acronym / sponsor ID
- MU-PRIOR / 9411
- Conditions
- Cancer of Colon, Surgery, Anxiety
- Keywords
- Music, Colon cancer, Surgery, Anxiety, Perioperative care, Prehabilitation, Non pharmacological intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 22 Nov 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 8 Aug 2023 (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.
The goal of this multicenter randomized controlled trial is to investigate the effect of music prehabilitation on preoperative anxiety in patients undergoing elective oncological colorectal resection. Patients will be asked to listen to music three times a day starting one week before day of surgery. Anxiety levels will be compared with the control group that is not explicitly instructed to listen to music by using validated questionnaires
Detailed description
Perioperative music interventions have been proven to have a positive effect on surgical patients regarding postoperative pain, anxiety and stress. Preoperative anxiety is a predictor for postoperative pain. It is hypothesized that preoperative anxiety develops at home. Unfortunately, data on this subject is scarce. Prehabilitation is a relatively new concept, which improves the patient's condition at home waiting for a surgical intervention. No studies exist in which music is implemented as a prehabilitation method. Music interventions are relatively simple low cost, sustainable and know no side effects. The researchers hypothesize that the use of pre-admittance music interventions as a prehabilitation modality in oncological colorectal surgical patients will decrease preoperative anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: MusicMusic intervention at home. Patients will be asked to listen to music using their own equipment three times a day. Starting approximately a week prior to surgery up to the day of surgery. |
| Standard Care | No intervention | –Treatment as usual. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged ≥ 16 years
- Patients undergoing elective oncological colorectal surgery at participating center
- Minimal hospital stay of 2 days postoperatively.
- Sufficient knowledge of the Dutch language
- Communicable and able to assess the questionnaires
Key exclusion criteria (10 listed)
- Patients with severe hearing impairment (defined as no or barely verbal communication possible).
- Patients with an expected stay of less than two nights in the hospital
- Patients who are professional musicians.
- Active music players or singers who may play or sing every week
- Patients who actively listen to music with a duration of > 30 minutes daily. Active listening is defined as music listening with headphones/earphones, while this is not combined with any other activity (e.g. exercising, working, driving or religious activities).
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 |
|---|---|---|
| MusicAlso: Music medicine, music interventionPatient preferred music listened to through earpieces or headphones using patients' own hardware and software. | Other | Music |
Primary outcome
Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission.
Time frame: Baseline and day of admittance to hospital
The STAI-6 questionnaire is a validated and frequently used six item questionnaire to assess anxiety. Six questions regarding feelings of anxiety are scored on a four point Likert scale. Scoring is achieved by reverse scoring of the positive items, sum all six scores, and multiplying the score by 20 divided by 6. The score ranges between 20 and 80, in which a higher score correlates with a higher anxiety level.
9 secondary outcomes
Patient reported pain on a 1-10 numeric scale.
Time frame: Thrice daily on each post-operative day until discharge
Incidence of delirium diagnosis made by geriatricians or psychiatrists
Time frame: Post-operative until discharge
Delirium observation scale scores (DOS).
Time frame: Post-operative until discharge
Subjective stress, measured with the 10-item perceived stress scale (PSS-10) questionnaire at baseline, day of admittance and at discharge.
Time frame: Baseline, day of admittance and discharge
Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire.
Time frame: 30 days postoperatively
Rate, timing and total dosages of medication given to the patient (sedatives, analgetics etc.)
Time frame: From admission to discharge
A self-made questionnaire assessing patient satisfaction regarding music intervention
Time frame: 4 weeks postoperatively at follow-up
Rate of complications
Time frame: Postoperatively until 30 days follow-up
Quality of recovery is a comprehensive 40-item questionnaire (QoR-40) used to assess the rate of recovery after surgery.
Time frame: 4 weeks postoperatively at follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Derived from this study: PubMed 40306915Verhoeven JG, Geensen R, Dirven TLA, Rietdijk WJR, Birnie E, Jeekel J, Klimek M. Study protocol for a multicentre randomised controlled trial using music prehabilitation to reduce preoperative anxiety before oncological colorectal surgery: the MU-PRIOR trial. BMJ Open. 2025 Apr 29;15(4):e095239. doi: 10.1136/bmjopen-2024-095239.
- 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. This study is not recruiting at the moment.
Markus Klimek, MD, PhD principal investigator
Erasmus Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Cancer of Colon and Surgery, run by Erasmus Medical Center at 5 sites in Netherlands.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission. (time frame: Baseline and day of admittance to hospital). 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 NCT05982184, 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 6 Jan 2026.