Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery
MU-PRIOR
1 other identifier
interventional
116
1 country
5
Brief 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. Anxiety levels will be compared with the control group that is not explicitly instructed to listen to music by using validated questionnaires
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2023
CompletedFirst Posted
Study publicly available on registry
August 8, 2023
CompletedStudy Start
First participant enrolled
October 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2025
CompletedJanuary 6, 2026
December 1, 2025
2.1 years
July 14, 2023
December 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and day of admittance to hospital
Secondary Outcomes (9)
Patient reported pain on a 1-10 numeric scale.
Thrice daily on each post-operative day until discharge
Incidence of delirium diagnosis made by geriatricians or psychiatrists
Post-operative until discharge
Delirium observation scale scores (DOS).
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.
Baseline, day of admittance and discharge
Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire.
30 days postoperatively
- +4 more secondary outcomes
Other Outcomes (8)
Age
At moment of surgery
Sex
at baseline
BMI
At admittance
- +5 more other outcomes
Study Arms (2)
Music
EXPERIMENTALMusic 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 INTERVENTIONTreatment as usual.
Interventions
Patient preferred music listened to through earpieces or headphones using patients' own hardware and software.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Amphia Ziekenhuis
Breda, North Brabant, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, 3318 AT, Netherlands
Franciscus Gasthuis
Rotterdam, South Holland, 3045 PM, Netherlands
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079 DZ, Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, Zeeland, Netherlands
Related Publications (1)
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.
PMID: 40306915DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus Klimek, MD, PhD
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 14, 2023
First Posted
August 8, 2023
Study Start
October 3, 2023
Primary Completion
November 22, 2025
Study Completion
December 12, 2025
Last Updated
January 6, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share