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Completed

NCT Number: NCT04232930

The Use of Music in Reducing Pain During Outpatient Hysteroscopy

The aim of this study is to demonstrate the value of music in outpatient hysteroscopy on patients' level of pain and satisfaction. This may have a role in our daily practice in providing a better patient care in outpatient hysteroscopy.

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pamela Youde Nethersole Eastern Hospital

Hong Kong, HongKong, 00000

About this study

Outpatient hysteroscopy is nowadays a commonly used procedure in Gynaecology in order to evaluate the uterine cavity and to diagnose different intrauterine diseases. It is a safe, convenient and cost-effective procedure in aiding the management of abnormal uterine bleeding. However, outpatient hysteroscopy can be associated with significant pain which would have impact on the woman's satisfaction and pain is one of the most common reasons for failure of the procedure.

Listening to music could be an easy and non-invasive way to reduce pain. A meta-analysis conducted on the effects of music on pain revealed that music interventions had statistically significant effects in decreasing pain on 0-10 pain scales. Researches on this topic in gynaecological office procedures, however, showed variation in the results. Some showed no positive effect of music on patient's level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. On the other hand, some studies showed a positive effect of the use of music with a reduction of pain and anxiety during office hysteroscopy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • indication for hysteroscopy (abnormal uterine bleeding, abnormal findings on ultrasound, and infertility)
  • signed informed consent
  • ability to read Chinese or English.

Exclusion criteria

  • hearing impairment
  • known anatomical abnormalities which would make performing the procedure more difficult
  • use of premedication for cervical ripening

Treatment and study plan

Music

Other

Four types of music will be provided, including pop, classical, jazz or spa music which are prepared by the study team. They contain instrumental songs only without vocal.

Primary outcomes

  1. Intensity of pain

    Time frame: Anticipated pain before hysteroscopy

    Pain measured using visual analog scale (VAS) on a 0-10 scale, with 0 indicating "no pain" and 10 indicating "worst pain possible".

  2. Intensity of pain

    Time frame: Actual pain experienced during hysteroscopy

    Pain measured using visual analog scale (VAS) on a 0-10 scale, with 0 indicating "no pain" and 10 indicating "worst pain possible".

Secondary outcomes

  1. Systolic blood pressure

    Time frame: Systolic blood pressure before hysteroscopy

    Systolic blood pressure

  2. Systolic blood pressure

    Time frame: Systolic blood pressure during hysteroscopy

    Systolic blood pressure

  3. Diastolic blood pressure

    Time frame: Diastolic blood pressure before hysteroscopy

    Diastolic blood pressure

  4. Diastolic blood pressure

    Time frame: Diastolic blood pressure during hysteroscopy

    Diastolic blood pressure

  5. Heart rate

    Time frame: Heart rate before hysteroscopy

    Heart rate

  6. Heart rate

    Time frame: Heart rate during hysteroscopy

    Heart rate

Sponsors and collaborators

Lead sponsor

Pamela Youde Nethersole Eastern Hospital

Other

Registry information

Official study title

The Use of Music in Reducing Pain During Outpatient Hysteroscopy: Prospective Randomized Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2020
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.