The Use of Music in Reducing Pain During Outpatient Hysteroscopy

NCT04232930 | Completed

• 1 other identifier: HKECREC-2019-034
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hysteroscopy

Outcome Measures

Primary Outcomes (2)

• Intensity of pain

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

  Anticipated pain before hysteroscopy

• Intensity of pain

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

  Actual pain experienced during hysteroscopy

Secondary Outcomes (6)

• Systolic blood pressure

  Systolic blood pressure before hysteroscopy

• Systolic blood pressure

  Systolic blood pressure during hysteroscopy

• Diastolic blood pressure

  Diastolic blood pressure before hysteroscopy

• Diastolic blood pressure

  Diastolic blood pressure during hysteroscopy

• Heart rate

  Heart rate before hysteroscopy

Study Arms (2)

Music group

ACTIVE COMPARATOR

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.

Other: Music

Non-music group

NO INTERVENTION

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

Interventions

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.

Music group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pamela Youde Nethersole Eastern Hospital: lead

Study Sites (1)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, HongKong, 00000, Hong Kong

Location

Related Publications (6)

• 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.

  PMID: 15507052 BACKGROUND

• 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.

  PMID: 30794005 BACKGROUND

• 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.

  PMID: 28890676 BACKGROUND

• 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.

  PMID: 23962572 BACKGROUND

• 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.

  PMID: 14529684 BACKGROUND

• 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.

  PMID: 27760797 BACKGROUND

Related Links

• Best Practice in Outpatient Hysteroscopy

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ho Ying Law

  Pamela Youde Nethersole Eastern Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Obstetrics and Gynaecology

Model Details: Prospective randomized trial

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: June 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The personal data will be kept for 3 years after the study. All the personal data will be discarded and destroyed after the storage period.
• Access Criteria: When a third party is interested to reanalyze study data or to combine data from multiple studies.

Locations

HK (1)