PainPhase 3NCT00772226
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit
A Phase 3 study testing music pillow and pillow without music in people with Pain and Ponv, run by Randers Regional Hospital at 2 sites in Denmark.
Trial summary
The study is undertaken to investigate whether relaxing music therapy before, during and after laparoscopic cholecystectomy has any effect on pain, PONV or fatigue and level of stress as measured by Cortisol and C reactive protein. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- music pillow and pillow without music
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2008to Sep 2012
- Phase
- Phase 3
- 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 patients going for laparoscopic cholecystectomy
Who cannot join
- Age below 18,
- Use of NSAID, morphine, steroids
- Disability
- Previous surgery in the past month
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
DaySurgical unit Regionshospital Randers
Randers, 8900
Regions Hospital Randers
Randers, 8900
About this study
The study is undertaken to investigate whether relaxing music therapy before, during and after laparoscopic cholecystectomy has any effect on pain, PONV or fatigue and level of stress as measured by Cortisol and C reactive protein.
Patients will be scored according to those endpoints 1 and 3 hours after surgery and on day 1 and 7 post-OP.
- Being tested
- music pillow, pillow without music
- Keywords
- laparoscopic cholecystectomy, pain, PONV, music, therapy, fatigue after elective laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative Nausea and Vomiting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music pillowDevice
according to randomisation patients will receive with/without music.
pillow without musicDevice
According to randomisation patients will receive a pillow with/without music
| Study group | Role | What they receive |
|---|---|---|
| music | Active comparator | Not described Receives: Device: music pillow |
| Pillow without music | Placebo comparator | Not described Receives: Device: pillow without music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant reduction in post operative VAS score
Measured: 1 week
Secondary outcomes (1)
Significant reduction in Stress hormone level (Cortisol and C reactive protein)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2012
- Study completionSep 2012
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Randers Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thorbjorn Sommer, Randers Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772226
- Sponsor's protocol ID
- 20080031
- Status last verified
- Sep 2012
- First submitted
- 14 Oct 2008
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit
- ClinicalTrials.gov ID
- NCT00772226
- Acronym / sponsor ID
- 20080031
- Keywords
- laparoscopic cholecystectomy, pain, PONV, music, therapy, fatigue after elective laparoscopic cholecystectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Randers Regional HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Oct 2008 (estimated)
- 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 study is undertaken to investigate whether relaxing music therapy before, during and after laparoscopic cholecystectomy has any effect on pain, PONV or fatigue and level of stress as measured by Cortisol and C reactive protein.
Patients will be scored according to those endpoints 1 and 3 hours after surgery and on day 1 and 7 post-OP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music | Active comparator | Device: music pillow |
| Pillow without music | Placebo comparator | Device: pillow without music |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients going for laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- Age below 18,
- Use of NSAID, morphine, steroids
- Disability
- Previous surgery in the past month
- Pregnancy
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 pillowaccording to randomisation patients will receive with/without music. | Device | music |
| pillow without musicAccording to randomisation patients will receive a pillow with/without music | Device | Pillow without music |
Primary outcome
Significant reduction in post operative VAS score
Time frame: 1 week
1 secondary outcome
Significant reduction in Stress hormone level (Cortisol and C reactive protein)
Time frame: 1 day
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 Sep 2012.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing music pillow and pillow without music in people with Pain and Ponv, run by Randers Regional Hospital at 2 sites in Denmark.
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 1 inclusion and 5 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 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Significant reduction in post operative VAS score (time frame: 1 week). 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 Sep 2012.