The Effect of Music Therapy Under Ultrasound Guided Manual Vacuum Aspiration
Recruiting · NCT04708808 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Women 18 years old or above
- hospitalized for termination of first trimester pregnancy under local anaesthesia
Exclusion criteria
- 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
Where it is running
1 location listed.
- Chinese University of Hong Kong - Hong Kong, Shatin, Hong Kong