The Effect of Music Therapy Under Ultrasound Guided Manual Vacuum Aspiration

NCT04708808 | Recruiting

• 1 other identifier: 2020.0503
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

First Trimester Abortion; Surgical Abortion; Music Intervention; Local Anesthesia; Pain

Keywords

music; termination of pregnancy; suction curettage; evacuation of gestational product; anxiety; abortion; pain; surgical abortion; aspiration abortion

Outcome Measures

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.

  During one day

Secondary Outcomes (4)

• 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 assess the patient's satisfaction and acceptance

  2 hours after 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

Other Outcomes (1)

• To assess any post operative physical discomfort

  immediate after post operative and 2 hours post operatively

Study Arms (2)

MVA case undergone music therapy

EXPERIMENTAL

case undergone manual vacuum aspiration are randomised to receive music therapy during the procedure.

Behavioral: music therapy

Control

NO INTERVENTION

Routine Care

Interventions

music therapy BEHAVIORAL

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.

Also known as: No music therapy, Routine Care

MVA case undergone music therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: First trimester miscarriage women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 years old or above
• hospitalized for termination of first trimester pregnancy under local anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Pui Wah Jacqueline Chung, MBBS, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiu Tan Margaret Lee

CONTACT

(852)35051764; margaretlee@cuhk.edu.hk

Pui Wah Jacqueline Chung, MBBS

CONTACT

(852)35051764; jacquelinechung@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: First trimester miscarriage case undergo the manual vaccum procedure.

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: January 14, 2021
• Study Start: August 30, 2020
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)