Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Pain Intensity (EVA Pain) in the recovery room (SSPI).
研究概览
简要总结
The study, "Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery," aims to evaluate the impact of preoperative listening to standardized music sequences on postoperative pain in patients undergoing proctologic surgery (for hemorrhoids, fistulas, or anal fissures).
This research will assess the influence of preoperative music on postoperative pain management, the use of analgesics after surgery and during the following month, and its effect on the quality of life post-surgery.
MUSICO-PROCTO is an interventional, randomized study involving two groups (patients will be randomly assigned to either the music intervention or control group). The study is monocentric, conducted at Clinique Saint Vincent in France, and includes 550 participants.
Participants will be followed for 28 days, while the overall study duration will span 28 months.
To participate, individuals must:
Be aged 18 or older. Be affiliated with a social security system. Provide signed informed consent. Undergo proctologic surgery for hemorrhoids, fistulas, or anal fissures. This study seeks to explore the potential of music as a complementary method to improve postoperative outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged over 18 years.
- •Patient who has signed an informed consent form.
- •Patient scheduled to undergo proctological surgery (for hemorrhoids, fistula, or anal fissure) at the participating institution.
- •Must be affiliated with a social security system or be a beneficiary of such a system.
- •Patient must have access to the necessary technical means (smartphone, computer, tablet) to use the Music Care® application.
排除标准
- •Refusal to consent.
- •Patient unable to read, write, or understand French.
- •Vulnerable patient according to Article L1121-6 of the French Public Health Code (CSP).
- •Adult patient under guardianship or curatorship or under legal protection (safeguard of justice).
- •Patient unable to personally give informed consent according to Article L.1121-8 of the CSP or an adult protected by law.
- •Pregnant or breastfeeding women according to Article L1121-5 of the CSP.
- •Patient who has already participated in a study within the last 12 months.
研究组 & 干预措施
Standardized Music Listening
Participants assigned to this arm will benefit from standardized music listening sessions via the Music Care® application.
Pre-surgery: At the entrance to the operating room, participants will spend 20 minutes lying on a stretcher in a dedicated room, listening to relaxing music sequences through a tablet and headphones provided by the research team. Participants can select their preferred musical style, tempo, and tracks.
Post-surgery: Participants will continue listening to music sequences daily for 20 minutes at home using their own devices (smartphone, tablet, or computer) until day 28 post-surgery.
干预措施: Standardized Music Listening Therapy (Other)
Standard Care
Participants assigned to this arm will not benefit from standardized music listening sessions.
Pre-surgery: Participants will proceed directly from their hospital room to the operating room without a music listening session.
Post-surgery: Participants will be managed according to standard care practices, with no additional interventions related to music therapy.
结局指标
主要结局
Pain Intensity (EVA Pain) in the recovery room (SSPI).
时间窗: Immediately post-surgery in the recovery room.
First postoperative pain measurement using the EVA (Visual Analog Scale), scored from 0 to 10, in the recovery room (SSPI).
次要结局
- Medico-Economic Impact(During the hospital stay.)
- Successive Pain and Anxiety Scores (EVA Pain and EVA Anxiety)(From hospitalization to Day 28 post-surgery.)
- State Anxiety Score (STAI-Y-ETAT)(From hospitalization to Day 28 post-surgery.)
- Kess Score(From hospitalization to Day 28 post-surgery)
- Total Time in SSPI and Hospitalization Duration(During the hospital stay.)
- Total Analgesic Consumption During Hospital Stay(Measured from hospital admission to hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure).)
- Time to Healing(From surgery to Day 28 post-surgery.)
- Quality of Life Scores (HEMO-FISS-QoL and EQ5D-5L)(From hospitalization to Day 28 post-surgery.)
- Patient Satisfaction(Immediately post-surgery, upon discharge from SSPI.)