HysteroscopyNCT04232930
The Use of Music in Reducing Pain During Outpatient Hysteroscopy
A study testing Music in people with Hysteroscopy, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysteroscopy
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- indication for hysteroscopy (abnormal uterine bleeding, abnormal findings on ultrasound, and infertility)
- signed informed consent
- ability to read Chinese or English.
Who cannot join
- hearing impairment
- known anatomical abnormalities which would make performing the procedure more difficult
- use of premedication for cervical ripening
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Pamela Youde Nethersole Eastern Hospital
Hong Kong, HongKong, 00000
About this study
Official title: The Use of Music in Reducing Pain During Outpatient Hysteroscopy: Prospective Randomized Trial
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.
Read the detailed description
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
- Hysteroscopy
- Being tested
- Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: Actual pain experienced during hysteroscopy
Secondary outcomes (6)
Systolic blood pressure
Systolic blood pressure
Measured: Systolic blood pressure before hysteroscopy
Systolic blood pressure
Systolic blood pressure
Measured: Systolic blood pressure during hysteroscopy
Diastolic blood pressure
Diastolic blood pressure
Measured: Diastolic blood pressure before hysteroscopy
Diastolic blood pressure
Diastolic blood pressure
Measured: Diastolic blood pressure during hysteroscopy
Heart rate
Heart rate
Measured: Heart rate before hysteroscopy
Heart rate
Heart rate
Measured: Heart rate during hysteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jun 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized trial
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamela Youde Nethersole Eastern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Law Ho Ying, Pamela Youde Nethersole Eastern Hospital
- Investigators
- Ho Ying Law, Principal investigator, Pamela Youde Nethersole Eastern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232930
- Sponsor's protocol ID
- HKECREC-2019-034
- Status last verified
- May 2020
- First submitted
- 14 Jan 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following individual participant data will be shared: * Background characteristics including age, body mass index, occupation, religion, education, marital status, parity and number of vaginal deliveries and history of hysteroscopic surgery * Details of the outpatient hysteroscopy including time, procedure and level of performing surgeon
Publications
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.
PubMed 15507052Amer-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.
PubMed 30794005Mak 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.
PubMed 28890676Angioli 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.
PubMed 23962572Chan 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.
PubMed 14529684Lee 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.
PubMed 27760797
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Music in Reducing Pain During Outpatient Hysteroscopy: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04232930
- Acronym / sponsor ID
- HKECREC-2019-034
- Conditions
- Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Pamela Youde Nethersole Eastern HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized trial
| Arm | Type | Receives |
|---|---|---|
| Music group | Active comparator | Other: MusicIn 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- indication for hysteroscopy (abnormal uterine bleeding, abnormal findings on ultrasound, and infertility)
- signed informed consent
- ability to read Chinese or English.
Key exclusion criteria (3 listed)
- hearing impairment
- known anatomical abnormalities which would make performing the procedure more difficult
- use of premedication for cervical ripening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicFour 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. | Other | Music group |
Primary outcome
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".
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".
6 secondary outcomes
Systolic blood pressure
Time frame: Systolic blood pressure before hysteroscopy
Systolic blood pressure
Time frame: Systolic blood pressure during hysteroscopy
Diastolic blood pressure
Time frame: Diastolic blood pressure before hysteroscopy
Diastolic blood pressure
Time frame: Diastolic blood pressure during hysteroscopy
Heart rate
Time frame: Heart rate before hysteroscopy
Heart rate
Time frame: Heart rate during hysteroscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 15507052Morgan 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.
- Background: PubMed 30794005Amer-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.
- Background: PubMed 28890676Mak 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.
- Background: PubMed 23962572Angioli 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.
- Background: PubMed 14529684Chan 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.
- Background: PubMed 27760797Lee 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.
- Best Practice in Outpatient HysteroscopyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The following individual participant data will be shared: * Background characteristics including age, body mass index, occupation, religion, education, marital status, parity and number of vaginal deliveries and history of hysteroscopic surgery * Details of the outpatient hysteroscopy including time, procedure and level of performing surgeon
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Ying Law principal investigator
Pamela Youde Nethersole Eastern Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Hysteroscopy, run by Pamela Youde Nethersole Eastern Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (time frame: Anticipated pain before hysteroscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04232930, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.