The Effect of Music Therapy Under Ultrasound Guided Manual Vacuum Aspiration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChinese University of Hong Kong
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Women 18 years old or above
hospitalized for termination of first trimester pregnancy under local anaesthesia
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
music therapy
Behavioralcases 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.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: MVA case undergone music therapyExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
To assess the change in post operatively pain score with or without MT at different time points
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.
Time frame
During one daySecondary outcomes
1
To assess the impact of MT on anxiety level
The client self rated the Chinese version of STAI-S subscore. It is a 20 item scale with a 4 point likert ranging from almost never to almost always. the total scores range from 20 to 80, with higher scores correlate with greater anxiety.
Time frame
During one day2
To assess the psychological distress during the past few weeks
The client self rated the Chinese version General Health Questionnaire, it consists of 12 questions with 4 likert point rating. It aims to evaluate whether there are any baseline psychological distress, higher score indicates a higher level of psychological morbidity.
Time frame
1 hour before the procedure3
To assess the patient's satisfaction and acceptance
The client self rated the Client Satisfaction Questionnaire, it consists of 12 questions with 4 likert point rating. Higher score indicates greater acceptance and satisfaction
Time frame
2 hours after the procedure4
To measure the patient's physiological stress level.
Saliva samples were collected via the passive drooling method , using a dedicated SaliCap collection device. All patients were asked not to eat or drink 1 hour before collection. The level is determined using the Indiko (Thermo Fisher Scientific) random access analyser to measure the physiological stress.
Time frame
Saliva samples were collected 1 hour before the procedure and 30 minutes after MVA procedureOther outcomes
1
To assess any post operative physical discomfort
The case will complete the questionnaire of 4-likert point, with no, mild, moderate and severe for symptoms of nausea, vomiting, dizziness, tiredness, shortness of breath
Time frame
immediate after post operative and 2 hours post operativelySponsors and contacts
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Source ClinicalTrials.gov