The Use of Music in Reducing Pain During Outpatient Hysteroscopy

NCT ID: NCT04232930

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

This is not a blinded study as both the participant and the care provider will be able to listen to the music if the subject is assigned into the music group.

Study Groups

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Music group

In the music group, music that chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphone in order to maintain a good communication and interaction between the participant and the doctor.

Group Type ACTIVE_COMPARATOR

Music

Intervention Type 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.

Non-music group

Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pamela Youde Nethersole Eastern Hospital

OTHER

Sponsor Role lead

Responsible Party

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Law Ho Ying

Resident, Department of Obstetrics and Gynaecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ho Ying Law

Role: PRINCIPAL_INVESTIGATOR

Pamela Youde Nethersole Eastern Hospital

Locations

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Pamela Youde Nethersole Eastern Hospital

Hong Kong, HongKong, Hong Kong

Site Status

Countries

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Hong Kong

References

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Morgan M, Dodds W, Wolfe C, Raju S. Women's views and experiences of outpatient hysteroscopy: implications for a patient-centered service. Nurs Health Sci. 2004 Dec;6(4):315-20. doi: 10.1111/j.1442-2018.2004.00202.x.

Reference Type BACKGROUND
PMID: 15507052 (View on PubMed)

Amer-Cuenca JJ, Marin-Buck A, Vitale SG, La Rosa VL, Caruso S, Cianci A, Lison JF. Non-pharmacological pain control in outpatient hysteroscopies. Minim Invasive Ther Allied Technol. 2020 Feb;29(1):10-19. doi: 10.1080/13645706.2019.1576054. Epub 2019 Feb 22.

Reference Type BACKGROUND
PMID: 30794005 (View on PubMed)

Mak N, Reinders IMA, Slockers SA, Westen EHMN, Maas JWM, Bongers MY. The effect of music in gynaecological office procedures on pain, anxiety and satisfaction: a randomized controlled trial. Gynecol Surg. 2017;14(1):14. doi: 10.1186/s10397-017-1016-2. Epub 2017 Aug 9.

Reference Type BACKGROUND
PMID: 28890676 (View on PubMed)

Angioli R, De Cicco Nardone C, Plotti F, Cafa EV, Dugo N, Damiani P, Ricciardi R, Linciano F, Terranova C. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):454-9. doi: 10.1016/j.jmig.2013.07.020. Epub 2013 Aug 17.

Reference Type BACKGROUND
PMID: 23962572 (View on PubMed)

Chan YM, Lee PW, Ng TY, Ngan HY, Wong LC. The use of music to reduce anxiety for patients undergoing colposcopy: a randomized trial. Gynecol Oncol. 2003 Oct;91(1):213-7. doi: 10.1016/s0090-8258(03)00412-8.

Reference Type BACKGROUND
PMID: 14529684 (View on PubMed)

Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19.

Reference Type BACKGROUND
PMID: 27760797 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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Other Identifiers

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HKECREC-2019-034

Identifier Type: -

Identifier Source: org_study_id

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