The Efficacy of Music as an Adjunct Analgesic in Reducing Pain and Anxiety During Ultrasound-guided Manual Vacuum Aspiration (USG-MVA): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- To assess the change in post operatively pain score with or without MT at different time points
研究概览
简要总结
Manual vacuum aspiration (MVA) is one of the surgical treatment options for managing early pregnancy loss. When compared to traditional surgical method; MVA is safer, more cost-effective, due to its shorter hospitalisation period and not undergo the risk of general anaesthesia. The MVA procedure is performed under local anaesthesia and analgesics is given prior the procedure. However, majority of patients still complaint significant pain during the procedure.
In our previous study, the investigator found women had high anxiety and stress levels when undergo miscarriage and the operation. Pain perception may further be affected by one's psychological state at the time of the procedure. Therefore reducing the patient's anxiety during the USG-MVA may further improve the patient's pain control and overall acceptance of the procedure.
Music can act as a distracter and has a calming effect which turn the patient's attention away from negative stimuli. Yet, there has been no RCTs to investigate the beneficial effect of music therapy in pain control or reducing anxiety levels during USG-MVA.
The investigator hypothesis the intervention of music therapy to our current pain control will reduce the pain and anxiety levels experienced by our patients during USG-MVA. Thus, there is a need to conduct an RCT to test our hypothesis.
The study is conducted in an university affilated hospital for women undergo the USG-MVA procedure. The primary outcome is to evaluate in between group difference in the pain intensity after the USG-guided MVA procedure. The secondary outcome is to evaluate the difference in anxiety level . Case is randomized to music and non music group, Bluetooth headphone are provided during the procedure and case can choose their favourite songs. The outcome are measured by the self rated instrument: Visual analogue scale and the STAI trait anxiety score and the physiological measure salivary alpha amylase (sAA )score. The pain score and the anxiety level is measured pre operatively, immediate after the procedure and 2 hours post operatively. The SPSS-26 will be used for statistics analysis.
详细描述
Title: The efficacy of music as an adjunct analgesic in reducing pain and anxiety during ultrasound-guided manual vacuum aspiration (USG-MVA): A randomized controlled trial.
Approximately one in four women will experience an early pregnancy loss in her lifetime. Manual vacuum aspiration (MVA) is one of the treatment options for managing early pregnancy loss. USG-MVA is safer, more cost-effective, and is associated with shorter hospital stay and cost than traditional surgical method. However, majority of patients experience significant pain during the procedure.
At present, there is no consensus on the optimal pain control regimen for USG-MVA. The pain generated from USG-MVA may be due to the dilatation of the cervix or insertion of the catheter or due to uterine contraction. Various analgesic methods have been used to reduce the pain including the use of paracervical block (PCB), non-steroidal anti-inflammatory drugs (NSAIDs), lidocaine gel and conscious sedation but the procedure is still not absolutely painless. Pain management remains an important factor in its success and patient acceptance.
In our previous study, the investigator evaluated the effectiveness of adding Buscopan®, an anti-spasmodic agent, as pain control regimen for women undergone the USG-MVA. Result found that the intervention group were more satisfied to the procedure than the placebo group. They had 15% and 21% lower pain score immediately after the operation as well as two hours post operatively. The investigator postulated the women receiving Buscopan® is being relieved from experiencing uterine spasms. However, the investigator found that the women had higher anxiety levels as reflected by the high anxiety scores in their Hospital Anxiety Depression Scale. Pain perception maybe affected by one's psychological state at the time of the procedure. And undergo a surgical procedure plus the diagnosis of miscarriage further increases their anxiety and stress levels. Therefore to reduce the patient's anxiety during the USG-MVA may further improve the patient's pain control and overall acceptance of the procedure.
Music is known to have a calming effect; previous studies have postulated that music can act as a distracter which turns the patient's attention away from negative stimuli. Another theory is that music activates brain as rewarding region which is responsible for pleasant experiences and happiness and induces dopamine release in striatal system. A systematic review of 42 randomized controlled trials of music interventions in the preoperative setting found music significantly reduced anxiety and pain. Previous studies also showed music as an auxiliary analgesic during first trimester surgical abortion but only with small sample size and mixed results. There has not been any RCTs to investigate the beneficial effect of music therapy in pain control or reducing anxiety levels during USG-MVA.
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
盲法说明
For those who consented to the study, they will be randomly assigned to receive music therapy or no according to a computer generated random number series. Each number will be placed in an opaque envelope labelled serially: (i) intervention group: routine care plus music given via headphone (ii) control group- routine care with no music or headphones.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years old or above
- •hospitalized for termination of first trimester pregnancy under local anaesthesia
排除标准
- •being a minor or adult protected by law
- •not feasible for MVA procedure
- •Partial or total hearing impairment
- •on anxiolytics and analgesics before arriving at the hospital
- •refusal to participate
研究组 & 干预措施
Control
Routine Care
MVA case undergone music therapy
case undergone manual vacuum aspiration are randomised to receive music therapy during the procedure.
干预措施: music therapy (Behavioral)
结局指标
主要结局
To assess the change in post operatively pain score with or without MT at different time points
时间窗: During one day
The case self rated the VAS score, VAS scores ranged from 0 to 100, where 0 indicated no pain and 100 indicated the worst pain imaginable. (T0) when entering the department, (T1) 30 minutes after administration of misoprostol, (T2) during the procedure, (T3) at the end of the procedure and (T4) 2 hours after the procedure.
次要结局
- To assess the impact of MT on anxiety level(During one day)
- To assess the psychological distress during the past few weeks(1 hour before the procedure)
- To measure the patient's physiological stress level.(Saliva samples were collected 1 hour before the procedure and 30 minutes after MVA procedure)
- To assess the patient's satisfaction and acceptance(2 hours after the procedure)
研究者
Chung Pui Wah Jacqueline
Associate Professor
Chinese University of Hong Kong
