Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery (MU-PRIOR)

Erasmus University

Status: Completed

Conditions: Cancer of Colon; Surgery; Anxiety

Treatments: Other: Music

Study type: Interventional

Funder types: Other

Identifiers

NCT05982184

9411

Details and patient eligibility

About

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

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Music

Experimental group

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.

Treatment:

Other: Music

Standard Care

No Intervention group

Description:

Treatment as usual.