Effect of Music Prehabilitation on Preoperative Anxiety in Patients Undergoing Colorectal Oncological Resection: a Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 5
- 主要终点
- Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Music (Other)
Standard Care
Treatment as usual.
结局指标
主要结局
Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission.
时间窗: Baseline and day of admittance to hospital
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.
次要结局
- Incidence of delirium diagnosis made by geriatricians or psychiatrists(Post-operative until discharge)
- Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire.(30 days postoperatively)
- Patient reported pain on a 1-10 numeric scale.(Thrice daily on each post-operative day until discharge)
- Delirium observation scale scores (DOS).(Post-operative until discharge)
- Subjective stress, measured with the 10-item perceived stress scale (PSS-10) questionnaire at baseline, day of admittance and at discharge.(Baseline, day of admittance and discharge)
- Rate, timing and total dosages of medication given to the patient (sedatives, analgetics etc.)(From admission to discharge)
- Quality of recovery is a comprehensive 40-item questionnaire (QoR-40) used to assess the rate of recovery after surgery.(4 weeks postoperatively at follow-up)
- A self-made questionnaire assessing patient satisfaction regarding music intervention(4 weeks postoperatively at follow-up)
- Rate of complications(Postoperatively until 30 days follow-up)
研究者
Markus Klimek
Principal Investigator
Erasmus Medical Center