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Trial Title:
Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery
NCT ID:
NCT05982184
Condition:
Cancer of Colon
Surgery
Anxiety
Conditions: Official terms:
Colonic Neoplasms
Anxiety Disorders
Conditions: Keywords:
Music
Colon cancer
Surgery
Anxiety
Perioperative care
Prehabilitation
Non pharmacological intervention
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Music
Description:
Patient preferred music listened to through earpieces or headphones using patients' own
hardware and software.
Arm group label:
Music
Other name:
Music medicine
Other name:
music intervention
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.
Criteria for 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.
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Albert Schweitzer Ziekenhuis
Address:
City:
Dordrecht
Zip:
3318 AT
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Eric Belt, Dr.
Facility:
Name:
Franciscus Gasthuis
Address:
City:
Rotterdam
Zip:
3045 PM
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marijn Poelman, Dr.
Facility:
Name:
Maasstad Ziekenhuis
Address:
City:
Rotterdam
Zip:
3079 DZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Erwin van der Harst, Dr
Start date:
October 3, 2023
Completion date:
September 2024
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05982184
