PainNCT05515302
Effect of Playing an Audio Clip for Pain and Anxiety Control in Patients While Dressing Burn Wounds
A study testing Audio Clip in people with Pain and Anxiety, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The aim of this clinical trial is to assess the effect of playing patient preferred audio clip for controlling the pain and anxiety in patients while dressing burn wounds. The age group to be selected for this explicit examination is 18 years and above. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Audio Clip
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteQatar
- Study dates
- 1 Aug 2022to 30 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients aged 18 years and above.
- Fit the diagnostic standard of severe burn injury as per the clinical guidelines with burns up to10%
- 30% the total body surface area. (TBSA).
- Hospitalized burn patients with an expected stay in hospital for 10 days at the time of signing the informed consent.
- Patient needs to be literate to understand the instruction and the audio clip and provide response for the questionnaire.
- Pain score before intervention >=4 NRS (moderate pain
Who cannot join
- Burn patients who are critically ill with ventilator support,
- Burn patient with respiratory problem or hearing impairment,
- Burn patients with cognitive impairments.
- Burn patient with diabetic neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Playing an Audio Clip for Pain and Anxiety Control for Burn Patients While Dressing Burn Wounds: Randomized Controlled Trial
The aim of this clinical trial is to assess the effect of playing patient preferred audio clip for controlling the pain and anxiety in patients while dressing burn wounds. The age group to be selected for this explicit examination is 18 years and above. The researcher will assess the pain and anxiety levels in both experimental and control groups having sample size of 50 each using standardized tools. The patient in intervention group will be offered selected audio clips to choose from. The patient preferred audio clips will be played for 10 days while the control group will be provided with treatment as usual. After collecting the data from both groups, it will be compared to analyze the effectiveness of listening to the audio clips chosen by the patient.
Read the detailed description
Burn related pain and anxiety is an important health problem. Surgical procedures and physical rehabilitation is commonly associated with pain and anxiety among burn injuries. Burn pain initially associated with size and degree of burn followed by post rehabilitation procedures and infections. Pain during burn incident and expectation of pain in treatment procedures create severe anxiety in most of the patients. In this investigation researcher is going to use listening to an audio clip (piece of self-selected music, sound from nature, or religious recitations) as a non-pharmacological intervention. Audio pieces are used for clinical purposes as complementary and alternative medicine. Although it is not practiced extensively due to the lack of evidence-based results in this particular area of research. This is an open label Randomized controlled trial aimed to assess the effectiveness of listening to an audio clip as an adjunct to TAU among hospitalized burns patient.
This study is open label, prospective, parallel group, randomized control design. The trial compares thosepatients with intervention group and control group with treatment as usual. Based on the inclusion criteria those patients with 10-30% of burns and need to stay in hospital for 10 days and withpain score of >=4 will be included in the study. The samples will be divided into two groups by randomly assigning the patients to each group. The analysis will be conducted to assess the effectiveness of listening to an audio clip for controlling pain and anxiety. No blinding or masking will be performed in this study.The patients in the intervention group will be introduced to the music player before and the procedure. After the preparation of the intervention subsequently on the same day or during the next day's prior to dressing NRS and BAI will be administered to evaluate the patient's pain and anxiety levels. After completion of intervention pain, anxiety and hemodynamic parameters will be collected. Treatment as usual will be provided for all control group patients as per Unit Protocol. The primary outcome was reduced pain and anxiety levels during the dressing changes as evidenced by reducing 15-20% in experimental group as compared to control group with treatment as usual.
- Being tested
- Audio Clip
- Keywords
- pain, anxiety, Burns Patients, Wound Dressing.
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio ClipOther
Selected Audio clips will be introduced to the study subjects during the Burns Dressing Changes. The Audio Clips will be selected as per subjects preference.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group consists of 50 Participants as per the inclusion criteria. The Audio clips will be administered to the experimental group. Receives: Other: Audio Clip |
| Control Group | No intervention | The control group will not receive the intervention but will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain intensity
Measures the changes in pain intensity with a Numerical Rating Scale from 0-10 with higher score indicates higher levels of pain and lower scores indicates less pain 15-20% in experimental group as compared to control group with treatment as usual.
Measured: Throughout study completion up to 10 days after randomization.
changes in anxiety level
Measures the changes in anxiety with Beck Anxiety Inventory scale from 0-63 maximum scores. Higher scores indicate higher levels of anxiety and lower scores indicates lower levels of anxiety.
Measured: Throughout study completion up to10 days after randomization.
Secondary outcomes (3)
changes in Heart rate
Measures changes in heart rate via hospital monitors , these changes are in beats per minute(bpm) and will be obtained prior to pre-intervention phase and immediately after post intervention phase.
Measured: Throughout study completion up to10 days after randamization .
changes in Respiratory rate
Measures changes in heart rate via hospital monitors ,these changes are in breaths per minute(bpm) and will be obtained prior to pre-intervention phase and immediately after post intervention phase.
Measured: Throughout study completion up to10 days after randomization.
Changes in Blood Pressure
Measures changes in blood pressure via hospital monitors ,these changes are in millimeters of mercury (mm hg) and will be obtained prior to pre-intervention phase and immediately after post intervention phase.
Measured: Throughout study completion up to 10 days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Aug 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- open label Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Resmi Lekhadevi, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515302
- Sponsor's protocol ID
- MRC-01-22-239
- Status last verified
- Jul 2024
- First submitted
- 18 Aug 2022
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Study data of Participants will not be shared outside Hamad Medical Corporation. The Data Will be managed according to the Norms of HMC- Medical Research Centre.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Playing an Audio Clip for Pain and Anxiety Control for Burn Patients While Dressing Burn Wounds: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05515302
- Acronym / sponsor ID
- MRC-01-22-239
- Keywords
- pain, anxiety, Burns Patients, Wound Dressing.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 25 Aug 2022 (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 clinical trial is to assess the effect of playing patient preferred audio clip for controlling the pain and anxiety in patients while dressing burn wounds. The age group to be selected for this explicit examination is 18 years and above. The researcher will assess the pain and anxiety levels in both experimental and control groups having sample size of 50 each using standardized tools. The patient in intervention group will be offered selected audio clips to choose from. The patient preferred audio clips will be played for 10 days while the control group will be provided with treatment as usual. After collecting the data from both groups, it will be compared to analyze the effectiveness of listening to the audio clips chosen by the patient.
Detailed description
Burn related pain and anxiety is an important health problem. Surgical procedures and physical rehabilitation is commonly associated with pain and anxiety among burn injuries. Burn pain initially associated with size and degree of burn followed by post rehabilitation procedures and infections. Pain during burn incident and expectation of pain in treatment procedures create severe anxiety in most of the patients. In this investigation researcher is going to use listening to an audio clip (piece of self-selected music, sound from nature, or religious recitations) as a non-pharmacological intervention. Audio pieces are used for clinical purposes as complementary and alternative medicine. Although it is not practiced extensively due to the lack of evidence-based results in this particular area of research. This is an open label Randomized controlled trial aimed to assess the effectiveness of listening to an audio clip as an adjunct to TAU among hospitalized burns patient.
This study is open label, prospective, parallel group, randomized control design. The trial compares thosepatients with intervention group and control group with treatment as usual. Based on the inclusion criteria those patients with 10-30% of burns and need to stay in hospital for 10 days and withpain score of >=4 will be included in the study. The samples will be divided into two groups by randomly assigning the patients to each group. The analysis will be conducted to assess the effectiveness of listening to an audio clip for controlling pain and anxiety. No blinding or masking will be performed in this study.The patients in the intervention group will be introduced to the music player before and the procedure. After the preparation of the intervention subsequently on the same day or during the next day's prior to dressing NRS and BAI will be administered to evaluate the patient's pain and anxiety levels. After completion of intervention pain, anxiety and hemodynamic parameters will be collected. Treatment as usual will be provided for all control group patients as per Unit Protocol. The primary outcome was reduced pain and anxiety levels during the dressing changes as evidenced by reducing 15-20% in experimental group as compared to control group with treatment as usual.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Audio ClipThe experimental group consists of 50 Participants as per the inclusion criteria. The Audio clips will be administered to the experimental group. |
| Control Group | No intervention | –The control group will not receive the intervention but will receive treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All adult patients aged 18 years and above.
- Fit the diagnostic standard of severe burn injury as per the clinical guidelines with burns up to10%
- 30% the total body surface area. (TBSA).
- Hospitalized burn patients with an expected stay in hospital for 10 days at the time of signing the informed consent.
- Patient needs to be literate to understand the instruction and the audio clip and provide response for the questionnaire.
Key exclusion criteria (4 listed)
- Burn patients who are critically ill with ventilator support,
- Burn patient with respiratory problem or hearing impairment,
- Burn patients with cognitive impairments.
- Burn patient with diabetic neuropathy
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 |
|---|---|---|
| Audio ClipSelected Audio clips will be introduced to the study subjects during the Burns Dressing Changes. The Audio Clips will be selected as per subjects preference. | Other | Experimental Group |
Primary outcome
change in pain intensity
Time frame: Throughout study completion up to 10 days after randomization.
Measures the changes in pain intensity with a Numerical Rating Scale from 0-10 with higher score indicates higher levels of pain and lower scores indicates less pain 15-20% in experimental group as compared to control group with treatment as usual.
changes in anxiety level
Time frame: Throughout study completion up to10 days after randomization.
Measures the changes in anxiety with Beck Anxiety Inventory scale from 0-63 maximum scores. Higher scores indicate higher levels of anxiety and lower scores indicates lower levels of anxiety.
3 secondary outcomes
changes in Heart rate
Time frame: Throughout study completion up to10 days after randamization .
changes in Respiratory rate
Time frame: Throughout study completion up to10 days after randomization.
Changes in Blood Pressure
Time frame: Throughout study completion up to 10 days after randomization.
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 11 Jul 2024.
- Individual participant dataSharing planned: No. The Study data of Participants will not be shared outside Hamad Medical Corporation. The Data Will be managed according to the Norms of HMC- Medical Research Centre.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio Clip in people with Pain and Anxiety, run by Hamad Medical Corporation at 1 site in Qatar.
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 6 inclusion and 4 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 11 Jul 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 Qatar. 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?
change in pain intensity (time frame: Throughout study completion up to 10 days after randomization.). 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?
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 11 Jul 2024.