Hip FracturesNCT06277102
Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture
A study testing music listening in people with Hip Fractures, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial summary
Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- music listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Jan 2024to 1 Jun 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Emergency admitted to QEH/G9 due to fragility hip fracture (#NOF or # TOF) within the study period
- Plan for surgical intervention
- Able to provide written informed consent
- Able to communicate in Cantonese/ Putonghua/ English
Who cannot join
- History of dementia
- Acute delirium upon admission
- Disorientated to time, person or place
- Concurrent fracture at other sites
- Utilization of other analgesics on top of pain protocol
- Appreciable deficits in hearing or vision
- Hemodynamically unstable
- Plan for neurolysis/ nerve block as definite treatment or opt for conservative treatment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Ward G9, Queen Elizabeth Hospital
Hong Kong
Kwan Yiu Jeffrey Lau, 62017014, lky194a@ha.org.hk
Kwan Yiu Jeffrey Lau
About this study
Official title: Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture: A Randomized Controlled Trial
Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. No study has been conducted focusing on pain control among cases with fragility hip fractures in an acute ward setting with non-schedule non-elective orthopaedic operation.
In Queen Elizabeth Hospital a standardized analgesic protocol is used for all fragility hip fracture cases unless contraindicated, a suboptimal post-operative pain control is not uncommonly seen. Stepping up analgesics is usually a concern in the elderly with a higher rate of side effects, a safe and simple non-pharmacological intervention for pain control is therefore needed.
The aim of this study is to study the effectiveness of incorporating music on pain intensity and mobility with the standard postoperative rehabilitation care of fragility hip fracture in Queen Elizabeth Hospital.
- Conditions
- Hip Fractures
- Being tested
- music listening
- Keywords
- pain control, music, fragility hip fracture
- Medical subject headings
- Hip Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music listeningOther
Music listening at postoperative day 1 and 2, 1 session per day, 20 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Music listening at postoperative day 1 and 2, 1 session per day, 20 minutes per session. Receives: Other: music listening |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by 11-point pain intensity numerical rating scale after music listening in postoperative Day 1 - 2 among subjects with fragility hip fracture
Measured: postoperative day 1 and 2
Secondary outcomes (2)
Modified functional ambulatory classification (MFAC) in postoperative Day 3 among subjects with fragility hip fracture
Measured: postoperative day 3
New mobility score (NMS) in postoperative Day 3 among subjects with fragility hip fracture
Measured: postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start26 Jan 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lau Kwan Yiu Jeffrey, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277102
- Sponsor's protocol ID
- Music pain FHF
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06277102
- Acronym / sponsor ID
- Music pain FHF
- Conditions
- Hip Fractures
- Keywords
- pain control, music, fragility hip fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 26 Feb 2024 (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.
Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. No study has been conducted focusing on pain control among cases with fragility hip fractures in an acute ward setting with non-schedule non-elective orthopaedic operation.
In Queen Elizabeth Hospital a standardized analgesic protocol is used for all fragility hip fracture cases unless contraindicated, a suboptimal post-operative pain control is not uncommonly seen. Stepping up analgesics is usually a concern in the elderly with a higher rate of side effects, a safe and simple non-pharmacological intervention for pain control is therefore needed.
The aim of this study is to study the effectiveness of incorporating music on pain intensity and mobility with the standard postoperative rehabilitation care of fragility hip fracture in Queen Elizabeth Hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: music listeningMusic listening at postoperative day 1 and 2, 1 session per day, 20 minutes per session. |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Emergency admitted to QEH/G9 due to fragility hip fracture (#NOF or # TOF) within the study period
- Plan for surgical intervention
- Able to provide written informed consent
- Able to communicate in Cantonese/ Putonghua/ English
Key exclusion criteria (8 listed)
- History of dementia
- Acute delirium upon admission
- Disorientated to time, person or place
- Concurrent fracture at other sites
- Utilization of other analgesics on top of pain protocol
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 |
|---|---|---|
| music listeningMusic listening at postoperative day 1 and 2, 1 session per day, 20 minutes per session. | Other | Music |
Primary outcome
Pain intensity measured by 11-point pain intensity numerical rating scale after music listening in postoperative Day 1 - 2 among subjects with fragility hip fracture
Time frame: postoperative day 1 and 2
2 secondary outcomes
Modified functional ambulatory classification (MFAC) in postoperative Day 3 among subjects with fragility hip fracture
Time frame: postoperative day 3
New mobility score (NMS) in postoperative Day 3 among subjects with fragility hip fracture
Time frame: postoperative day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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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.
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 listening in people with Hip Fractures, run by Hospital Authority, Hong Kong 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwan Yiu Jeffrey Lau (62017014, lky194a@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured by 11-point pain intensity numerical rating scale after music listening in postoperative Day 1 - 2 among subjects with fragility hip fracture (time frame: postoperative day 1 and 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024.