Clinical trial NCT05982184: Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery
Official title: Effect of Music Prehabilitation on Preoperative Anxiety in Patients Undergoing Colorectal Oncological Resection: a Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer of Colon
Surgery
Anxiety
Keywords: Music
Colon cancer
Surgery
Anxiety
Perioperative care
Prehabilitation
Non pharmacological intervention
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 116
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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
Secondary outcomes:
measure: Patient reported pain on a 1-10 numeric scale.
timeFrame: Thrice daily on each post-operative day until discharge
measure: Incidence of delirium diagnosis made by geriatricians or psychiatrists
timeFrame: Post-operative until discharge
measure: Delirium observation scale scores (DOS).
timeFrame: Post-operative until discharge
measure: Subjective stress, measured with the 10-item perceived stress scale (PSS-10) questionnaire at baseline, day of admittance and at discharge.
timeFrame: Baseline, day of admittance and discharge
measure: Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire.
timeFrame: 30 days postoperatively
measure: Rate, timing and total dosages of medication given to the patient (sedatives, analgetics etc.)
timeFrame: From admission to discharge
measure: A self-made questionnaire assessing patient satisfaction regarding music intervention
timeFrame: 4 weeks postoperatively at follow-up
measure: Rate of complications
timeFrame: Postoperatively until 30 days follow-up
measure: Quality of recovery is a comprehensive 40-item questionnaire (QoR-40) used to assess the rate of recovery after surgery.
timeFrame: 4 weeks postoperatively at follow-up
Other outcomes:
measure: Age
timeFrame: At moment of surgery
measure: Sex
timeFrame: at baseline
measure: BMI
timeFrame: At admittance
measure: Surgery characteristics
timeFrame: Intraoperatively
measure: Prior medical history
timeFrame: At baseline
measure: Music preferences in daily life. An 8-item researcher made questionnaire.
timeFrame: At baseline
measure: Length of sedation in minutes
timeFrame: Perioperatively
measure: Rate and type of complications during surgery as recorded in the EHR
timeFrame: From entering the operation room to exit to postoperative nursing ward of post-anesthesia care unit (PACU)
Locations:
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
state: Noord-Brabant
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Ziekenhuis
state: Zeeland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Markus Klimek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: