PainNCT01941212
Effect of Music Therapy Intervention on Pain After Gynecological Surgery
A study testing Music therapy in people with Pain, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
To evaluate the effect of musical therapy before and after gynecological surgeries on pain relief following surgery. The hypothesis is that musical therapy is effective in pain relief following surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Sep 2014
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women are schedule to undergo gynecological surgeries
Who cannot join
- Neuropathy
- Neurological conditions
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of musical therapy before and after gynecological surgeries on pain relief following surgery.
The hypothesis is that musical therapy is effective in pain relief following surgical procedures.
Read the detailed description
The intention with the study is to focus on the first postoperative phase in a case of pain upon gynecologic abdominal surgery. The literature search revealed studies reporting that participates who had pre-operative session of music intervention for relaxation experienced a greater level of reducing pain levels both pre and post their operation than in the participates in the control group. It is therefore a decision to include one pre operative session of intervention with music therapy in the design.
The study will carry out at the Gynecologic Unit, in Rambam Hospital, Israel.
- Conditions
- Pain
- Being tested
- Music therapy
- Keywords
- Music therapy, pain, gynecological surgeries
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
Music therapy will be given to patients 24 hours prior and for the first 48 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Music therapy and Behavioral therapy | Active comparator | Music and behavioral therapy Receives: Behavioral: Music therapy |
| Music only | Active comparator | Music therapy without behavioral therapy Receives: Behavioral: Music therapy |
| Control | No intervention | Patients will not listen to music neither will get music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level following surgery
VAS will be used for the evaluation of pain level
Measured: 48 hours following suegery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lior Lowenstein, MD, MS, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941212
- Sponsor's protocol ID
- RMB 017-13
- Status last verified
- Sep 2013
- First submitted
- 10 Sep 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Therapy Intervention on Pain After Gynecological Surgery
- ClinicalTrials.gov ID
- NCT01941212
- Acronym / sponsor ID
- RMB 017-13
- Conditions
- Pain
- Keywords
- Music therapy, pain, gynecological surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 13 Sep 2013 (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.
To evaluate the effect of musical therapy before and after gynecological surgeries on pain relief following surgery.
The hypothesis is that musical therapy is effective in pain relief following surgical procedures.
Detailed description
The intention with the study is to focus on the first postoperative phase in a case of pain upon gynecologic abdominal surgery. The literature search revealed studies reporting that participates who had pre-operative session of music intervention for relaxation experienced a greater level of reducing pain levels both pre and post their operation than in the participates in the control group. It is therefore a decision to include one pre operative session of intervention with music therapy in the design.
The study will carry out at the Gynecologic Unit, in Rambam Hospital, Israel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music therapy and Behavioral therapy | Active comparator | Behavioral: Music therapyMusic and behavioral therapy |
| Music only | Active comparator | Behavioral: Music therapyMusic therapy without behavioral therapy |
| Control | No intervention | –Patients will not listen to music neither will get music therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women are schedule to undergo gynecological surgeries
Key exclusion criteria (3 listed)
- Neuropathy
- Neurological conditions
- Diabetes
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 therapyMusic therapy will be given to patients 24 hours prior and for the first 48 hours after surgery | Behavioural | Music only, Music therapy and Behavioral therapy |
Primary outcome
Pain level following surgery
Time frame: 48 hours following suegery
VAS will be used for the evaluation of pain level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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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.
Lior Lowenstein, MD, MS principal investigator
Rambam Health Care Campus
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 therapy in people with Pain, run by Rambam Health Care Campus at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 17 Sep 2013. 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 Israel. 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?
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?
Pain level following surgery (time frame: 48 hours following suegery). 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 17 Sep 2013.