Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery

NCT ID: NCT05982184

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2025-12-12

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music

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.

Group Type: EXPERIMENTAL

Music

Intervention Type: OTHER

Patient preferred music listened to through earpieces or headphones using patients' own hardware and software.

Standard Care

Treatment as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music

Patient preferred music listened to through earpieces or headphones using patients' own hardware and software.

Intervention Type: OTHER

Other Intervention Names

Music medicine; music intervention

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Markus Klimek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Klimek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Amphia Ziekenhuis

Breda, North Brabant, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Netherlands

Franciscus Gasthuis

Rotterdam, South Holland, Netherlands

Maasstad Ziekenhuis

Rotterdam, South Holland, Netherlands

Admiraal de Ruyter Ziekenhuis

Goes, Zeeland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 40306915 (View on PubMed)

Other Identifiers

9411

Identifier Type: -

Identifier Source: org_study_id