Closed Fracture of Shaft of FemurNCT04175574
Effects of Music on Post-operative Pain and Anxiety
A study testing Music in people with Closed Fracture of Shaft of Femur and Postoperative Pain, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
It has been hypothesized that because music has the ability to motivate, promote relaxation, alleviate pain and anxiety levels, to distract, and facilitate positive emotional states; thus it will enable healing by reducing anxiety levels which are associated with expected pain, hence patients are more unperturbed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Closed Fracture of Shaft of Femur, Postoperative Pain, Postoperative Anxiety
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2021to 31 Dec 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Consent to having the surgery and general anaesthesia
- Free from cognitive impairment
- Free from non-communicable diseases
- Mentally stable
- No appreciable deficits in vision and hearing
- American Society of Anaesthesiology (ASA) physical status classification of 1, 2, or 3
Show all 9Show fewer
- Able to communicate either in English or Bahasa Malaysia
- Admitted to the Orthopaedic ward post-operatively
- Alert and cognizant to complete the pain and anxiety scores
Who cannot join
- Patient refusal for surgery and anaesthesia
- Patients anticipated to have difficult airway and planned for higher level airway management such as awake fibreoptic intubation, tracheostomy under local anaesthetic.
- Patients who are cognitively impaired
- Women under hormonal treatment
- Diagnosed with auto immune disease
- Deaf and vision impaired
- Current use of anti-psychotic medication
- Haemodynamically not stable
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Serdang Hospital
Serdang, Selangor, 43400
Pri H. Chaskar, PhD
About this study
Official title: Effects of Music on Pain and Anxiety During Post-operative Period in Closed Shaft Femur Fracture Patients in Serdang Hospital and University Malaya Medical Centre
It has been hypothesized that because music has the ability to motivate, promote relaxation, alleviate pain and anxiety levels, to distract, and facilitate positive emotional states; thus it will enable healing by reducing anxiety levels which are associated with expected pain, hence patients are more unperturbed. In addition, several studies in the past have also identified that music listening can reduce the need for analgesics before surgery and after surgery to alleviate pain, reduce the period of post-operative pain and aid in the recovery period. While most studies which had administered music listening in the post-anaesthesia care unit (PACU), had found significant findings compared to patients that did not listen to music; there are few others which found otherwise.
Over decades, time and again, researchers have tried to understand how non-pharmacological interventions have been utilized in a spectrum of rehabilitation settings in populations to stimulate convalesces. This is because non-pharmacological interventions have been recognised as valuable, simple, safe, and inexpensive adjuvants to pharmacological approaches in pain management and therefore is valuable during post-operative rehabilitation especially.
Read more
This research is necessary because it hopes to address the gap of knowledge concerning the effects of music in post-operative pain, anxiety objectively in a specific population, and during an explicit time frame in a public hospital setting in Malaysia and whether by listening to music, the patients will require lesser amount of opioids analgesics.
The purpose of this study is to examine the effects of music on pain and anxiety during post-operative period in patients with closed shaft femur fracture at University of Malaya Medical Centre.
Read the detailed description
The administration of music as an adjuvant to medicine during the recovery after surgery especially should be further explored by examining the physiological parameters of what takes place in the human body when pain and anxiety are present.
Permision to conduct this study have been granted by the National Medical Research Registry of the Ministry of Health of Malaysia, the Medical Research Ethics Committee from Universiti Putra Malaysia as well as University of Malaya.
During the intervention, the standard course of treatment by the attending physician will not be interrupted. The patients have the liberty to drop out from the study at any point of time without any repercussion.
The Standard Operating Procedure for all information obtained in this study will be kept and handled in a confidential manner, and destroyed thereafter analysis in accordance with applicable laws and regulations by the Ethics Committee of Universiti Putra Malaysia. When publishing or presenting the study results, the identity of the patients will not be revealed. Only individuals involved in this study such as the researchers, attending physicians, qualified monitors and auditors, Universiti Putra Malaysia or its affiliates and governmental or regulatory authorities can access the data from this study.
The sample size assessment to specify the number of participants was necessary to demonstrate an effect.
Data collected will be coded and transferred into the SPSS (Version 25.0) for analyses. Appropriate tests will be selected based on whether the data is normally distributed or not. P-value will be set to 0.05 to indicate level of significance with confidence interval of 95%. Depending on the distribution of the data, the appropriate statistical analysis will be determined to compare pre- and post-test results. Descriptive statistical analysis will be performed on all study variable at each time point. Spearman correlation coefficient will be used to determine the correlation of the main study outcomes, which are pain and anxiety. Inferential statistical analysis such as t-test and Chi-square will be used to determine the existence of significance differences in demography of the patients. Paired t-test will be used to differentiate the results between the pre- and post-test for the pain and anxiety scores. A normality test, Kolmogorov-Smirnov test, will be performed to look at the distribution of the data. For comparison between the experimental and control group, the Mann-Whitney U and one-way analysis of variance (ANOVA) tests will be performed to using the median and mean scores from both groups and as well the dosage of analgesia prescribed to both groups.
Missing information will be recorded but not included in the data analysis. Data collected, processed and churned for results and reported by the researcher will be closely monitored by a certified medical statistician who has been appointed to advice the research team. The supervisory committee will retain all rights to advise on the development of the research.
- Being tested
- Music
- Keywords
- post-operative pain relief, post-operative anxiety, non-pharmacological adjuvant, closed shaft femur fracture, randomised controlled trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
The music has no lyrics, has a sustained melodic quality, has no strong rhythms and percussion or base, rate of 60-80 beats per minute, promotes relaxation, calming and soothing, neutral and is unbiased towards any culture or age. The volume of the music will be pre-adjusted to the patients' preference (preferable 30 dB) by the research assistant.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention consist of the patients in the experimental group listening to pre-recorded music played through a set of noise cancelling Sony headphones which are padded for extra comfort from a Sony Digital Walkman. The duration of the intervention is 30 minutes without interruption, such as eating, talking and being on their mobile phones. Receives: Other: Music |
| Control group | No intervention | Whereas, patients in the control group will be given similar headphones but without any music. They will also be briefed not to eat, talk and being on their mobile phones. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score using the Numeric Rating Scale (NRS)
Mean score of pain level (1-3 = mild; 4-6 = moderate; 7-10 = severe)
Measured: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.
Brief Pain Inventory (BPI)
Worst, least and average pain in the last 24 hours
Measured: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.
Anxiety score using the Generalized Anxiety Disorder-7 (GAD-7)
Mean score of anxiety level (0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 severe anxiety)
Measured: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.
Secondary outcomes (7)
Opioid dosage
Average amount of opioids (mg) ingested between the intervention and control group
Measured: 48 hours post surgery
Pro-inflammatory cytokine Interleukin 6 (IL-6)
Pro-inflammatory cytokine Interleukin 6 (IL-6) (pg)
Measured: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Cortisol level
Cortisol level (microlitres)
Measured: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Heart Rate
Heart rate (bpm)
Measured: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Respiratory Rate
Respiratory rate (breaths per minute)
Measured: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Systolic and diastolic Blood pressure
Systolic and diastolic Blood pressure (mmHg)
Measured: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Oxygen saturation
Oxygen saturation (%)
Measured: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Dec 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Fracture of Shaft of FemurStudies 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
- The design of this study is a randomised controlled trial based on the CONSORT 2010 flow diagram. Patients warded at the orthopaedics wards in two government hospitals, who have been hospitalized following a closed midshaft femur fracture and planned for surgery. Patients who fulfill the inclusion criteria will be invited to participate in this study. Recruitment to participate is based on voluntary and they will be given the patient information sheet, written informed consent and briefed on the protocol of the study. The patients will be randomised either in the intervention or control group by selecting an opaque envelope.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya
- Responsible party
- Principal investigator, PRI CHASKAR, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175574
- Sponsor's protocol ID
- UPM2019MUSICINMEDICINE
- Status last verified
- Dec 2021
- First submitted
- 2 Sep 2019
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music on Pain and Anxiety During Post-operative Period in Closed Shaft Femur Fracture Patients in Serdang Hospital and University Malaya Medical Centre
- ClinicalTrials.gov ID
- NCT04175574
- Acronym / sponsor ID
- UPM2019MUSICINMEDICINE
- Keywords
- post-operative pain relief, post-operative anxiety, non-pharmacological adjuvant, closed shaft femur fracture, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- University of Malaya
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Nov 2019 (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.
It has been hypothesized that because music has the ability to motivate, promote relaxation, alleviate pain and anxiety levels, to distract, and facilitate positive emotional states; thus it will enable healing by reducing anxiety levels which are associated with expected pain, hence patients are more unperturbed. In addition, several studies in the past have also identified that music listening can reduce the need for analgesics before surgery and after surgery to alleviate pain, reduce the period of post-operative pain and aid in the recovery period. While most studies which had administered music listening in the post-anaesthesia care unit (PACU), had found significant findings compared to patients that did not listen to music; there are few others which found otherwise.
Over decades, time and again, researchers have tried to understand how non-pharmacological interventions have been utilized in a spectrum of rehabilitation settings in populations to stimulate convalesces. This is because non-pharmacological interventions have been recognised as valuable, simple, safe, and inexpensive adjuvants to pharmacological approaches in pain management and therefore is valuable during post-operative rehabilitation especially.
This research is necessary because it hopes to address the gap of knowledge concerning the effects of music in post-operative pain, anxiety objectively in a specific population, and during an explicit time frame in a public hospital setting in Malaysia and whether by listening to music, the patients will require lesser amount of opioids analgesics.
The purpose of this study is to examine the effects of music on pain and anxiety during post-operative period in patients with closed shaft femur fracture at University of Malaya Medical Centre.
Detailed description
The administration of music as an adjuvant to medicine during the recovery after surgery especially should be further explored by examining the physiological parameters of what takes place in the human body when pain and anxiety are present.
Permision to conduct this study have been granted by the National Medical Research Registry of the Ministry of Health of Malaysia, the Medical Research Ethics Committee from Universiti Putra Malaysia as well as University of Malaya.
During the intervention, the standard course of treatment by the attending physician will not be interrupted. The patients have the liberty to drop out from the study at any point of time without any repercussion.
The Standard Operating Procedure for all information obtained in this study will be kept and handled in a confidential manner, and destroyed thereafter analysis in accordance with applicable laws and regulations by the Ethics Committee of Universiti Putra Malaysia. When publishing or presenting the study results, the identity of the patients will not be revealed. Only individuals involved in this study such as the researchers, attending physicians, qualified monitors and auditors, Universiti Putra Malaysia or its affiliates and governmental or regulatory authorities can access the data from this study.
The sample size assessment to specify the number of participants was necessary to demonstrate an effect.
Data collected will be coded and transferred into the SPSS (Version 25.0) for analyses. Appropriate tests will be selected based on whether the data is normally distributed or not. P-value will be set to 0.05 to indicate level of significance with confidence interval of 95%. Depending on the distribution of the data, the appropriate statistical analysis will be determined to compare pre- and post-test results. Descriptive statistical analysis will be performed on all study variable at each time point. Spearman correlation coefficient will be used to determine the correlation of the main study outcomes, which are pain and anxiety. Inferential statistical analysis such as t-test and Chi-square will be used to determine the existence of significance differences in demography of the patients. Paired t-test will be used to differentiate the results between the pre- and post-test for the pain and anxiety scores. A normality test, Kolmogorov-Smirnov test, will be performed to look at the distribution of the data. For comparison between the experimental and control group, the Mann-Whitney U and one-way analysis of variance (ANOVA) tests will be performed to using the median and mean scores from both groups and as well the dosage of analgesia prescribed to both groups.
Missing information will be recorded but not included in the data analysis. Data collected, processed and churned for results and reported by the researcher will be closely monitored by a certified medical statistician who has been appointed to advice the research team. The supervisory committee will retain all rights to advise on the development of the research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The design of this study is a randomised controlled trial based on the CONSORT 2010 flow diagram. Patients warded at the orthopaedics wards in two government hospitals, who have been hospitalized following a closed midshaft femur fracture and planned for surgery. Patients who fulfill the inclusion criteria will be invited to participate in this study. Recruitment to participate is based on voluntary and they will be given the patient information sheet, written informed consent and briefed on the protocol of the study. The patients will be randomised either in the intervention or control group by selecting an opaque envelope.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: MusicThe intervention consist of the patients in the experimental group listening to pre-recorded music played through a set of noise cancelling Sony headphones which are padded for extra comfort from a Sony Digital Walkman. The duration of the intervention is 30 minutes without interruption, such as eating, talking and being on their mobile phones. |
| Control group | No intervention | –Whereas, patients in the control group will be given similar headphones but without any music. They will also be briefed not to eat, talk and being on their mobile phones. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Consent to having the surgery and general anaesthesia
- Free from cognitive impairment
- Free from non-communicable diseases
- Mentally stable
- No appreciable deficits in vision and hearing
Key exclusion criteria (8 listed)
- Patient refusal for surgery and anaesthesia
- Patients anticipated to have difficult airway and planned for higher level airway management such as awake fibreoptic intubation, tracheostomy under local anaesthetic.
- Patients who are cognitively impaired
- Women under hormonal treatment
- Diagnosed with auto immune disease
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 |
|---|---|---|
| MusicThe music has no lyrics, has a sustained melodic quality, has no strong rhythms and percussion or base, rate of 60-80 beats per minute, promotes relaxation, calming and soothing, neutral and is unbiased towards any culture or age. The volume of the music will be pre-adjusted to the patients' preference (preferable 30 dB) by the research assistant. | Other | Intervention group |
Primary outcome
Pain score using the Numeric Rating Scale (NRS)
Time frame: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.
Mean score of pain level (1-3 = mild; 4-6 = moderate; 7-10 = severe)
Brief Pain Inventory (BPI)
Time frame: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.
Worst, least and average pain in the last 24 hours
Anxiety score using the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.
Mean score of anxiety level (0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 severe anxiety)
7 secondary outcomes
Opioid dosage
Time frame: 48 hours post surgery
Pro-inflammatory cytokine Interleukin 6 (IL-6)
Time frame: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Cortisol level
Time frame: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Heart Rate
Time frame: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Respiratory Rate
Time frame: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Systolic and diastolic Blood pressure
Time frame: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Oxygen saturation
Time frame: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: No
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 in people with Closed Fracture of Shaft of Femur and Postoperative Pain, run by Universiti Putra Malaysia at 1 site in Malaysia.
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 9 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 2 Dec 2021. 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 Malaysia. 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 Pri H. Chaskar, MMedSc (+601111110600, prichaskar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score using the Numeric Rating Scale (NRS) (time frame: The change between the baseline and post-intervention will be assessed. The intervention is for 30 minutes long and will be administered 24 hours post surgery.). The study lists 3 primary outcomes in all. 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 2 Dec 2021.