RecruitingNot ApplicableNCT04708808

The Effect of Music Therapy Under Ultrasound Guided Manual Vacuum Aspiration

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


Sponsor

Chinese University of Hong Kong

Enrollment

176 participants

Start Date

Aug 30, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether playing music during an ultrasound-guided manual vacuum aspiration (MVA) procedure — a method for ending a first-trimester pregnancy — can reduce anxiety and pain for patients who are awake under local anesthesia. **You may be eligible if...** - You are 18 or older - You are having a first-trimester pregnancy termination using manual vacuum aspiration under local anesthesia - You are hospitalized for this procedure **You may NOT be eligible if...** - You are a minor or a legally protected adult - The MVA procedure is not appropriate or feasible for you - You have partial or complete hearing loss - You are already taking anxiety-reducing or pain medications before arriving at the hospital - You do not wish to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALmusic therapy

cases will randomly assigned to receive music therapy group with routine care, plus music given via headphone, or assign to control group with no music given.


Locations(1)

Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

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NCT04708808


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