Clinical trial · Interventional
Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery
Effect of Music Prehabilitation on Preoperative Anxiety in Patients Undergoing Colorectal Oncological Resection: a Multicentre Randomized Controlled Trial
NCT05982184CI-TRIAL-00100195MU-PRIORcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer of Colon | Malignant Colon Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Music | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Music
- description
- 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.
- interventionNames
- Other: Music
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- Treatment as usual.
Primary outcomes (1)
- measure
- Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission.
- timeFrame
- Baseline and day of admittance to hospital
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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.
References
Publications (1)
- DERIVEDVerhoeven 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 40306915