Cervical Intraepithelial NeoplasiaNCT02398916
Music Listening to Reduce Pain and Anxiety During LEEP
A study testing Music listening in people with Cervical Intraepithelial Neoplasia, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Loop electrosurgical excision procedure (LEEP) is the primary diagnostic and therapeutic procedure employed in women with high-grade intraepithelial neoplasia of the cervix. The procedure usually performed in the outpatient setting under local anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Music listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2015to Aug 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with confirmed or suspected high-grade intraepithelial neoplasia of the cervix
Who cannot join
- Allergy to local anesthetic agent (lidocaine)
- Pregnancy
- Previous major surgical procedures on cervix (conization, LEEP, laser therapy, cryotherapy) or uterus
- Using cardiac pacemaker or history of cardiac arrhythmia
- Neurological disorder affecting perception of pain
- History of lower urinary tract cancer
Show all 11Show fewer
- Coagulation defects
- History of drug dependence
- Lower genital tract infection
- Apparent invasive cancer of the cervix
- Hearing difficulty
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, 50200
About this study
Official title: Effects of Music Listening During Loop Electrosurgical Excision Procedure on Anxiety, Pain, and Satisfaction: a Randomized Controlled Trial
Loop electrosurgical excision procedure (LEEP) is the primary diagnostic and therapeutic procedure employed in women with high-grade intraepithelial neoplasia of the cervix. The procedure usually performed in the outpatient setting under local anesthesia. However, it could be associated with significant pain and anxiety.
The aim of this study is to examine the effects of listening to music during the procedure in reducing pain and anxiety.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Music listening
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | * Listening to relaxing music for the entire period starting from waiting period in the surgical waiting area until the end of the LEEP procedure
* Undergoing LEEP according to the usual protocol Receives: Behavioral: Music listening |
| Control | No intervention | - Undergoing LEEP according to the usual protocol without listening to music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure-related pain, as measured by Visual Analog Scale
Measured: During the procedure
Secondary outcomes (2)
Procedure-related anxiety, as measured by Visual Analog Scale
Measured: During the procedure
Procedure-related satisfaction, as measured by Visual Analog Scale
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipat Charoenkwan, MD, Chiang Mai University
- Investigators
- Kittipat Charoenkwan, MD, Principal investigator, Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398916
- Sponsor's protocol ID
- OBG-2557-02665
- Status last verified
- Aug 2016
- First submitted
- 27 Feb 2015
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Listening During Loop Electrosurgical Excision Procedure on Anxiety, Pain, and Satisfaction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02398916
- Acronym / sponsor ID
- OBG-2557-02665
- Conditions
- Cervical Intraepithelial Neoplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Mar 2015 (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.
Loop electrosurgical excision procedure (LEEP) is the primary diagnostic and therapeutic procedure employed in women with high-grade intraepithelial neoplasia of the cervix. The procedure usually performed in the outpatient setting under local anesthesia. However, it could be associated with significant pain and anxiety.
The aim of this study is to examine the effects of listening to music during the procedure in reducing pain and anxiety.
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 | Behavioral: Music listening* Listening to relaxing music for the entire period starting from waiting period in the surgical waiting area until the end of the LEEP procedure * Undergoing LEEP according to the usual protocol |
| Control | No intervention | –- Undergoing LEEP according to the usual protocol without listening to music |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with confirmed or suspected high-grade intraepithelial neoplasia of the cervix
Key exclusion criteria (11 listed)
- Allergy to local anesthetic agent (lidocaine)
- Pregnancy
- Previous major surgical procedures on cervix (conization, LEEP, laser therapy, cryotherapy) or uterus
- Using cardiac pacemaker or history of cardiac arrhythmia
- Neurological disorder affecting perception of pain
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 listening | Behavioural | Music |
Primary outcome
Procedure-related pain, as measured by Visual Analog Scale
Time frame: During the procedure
2 secondary outcomes
Procedure-related anxiety, as measured by Visual Analog Scale
Time frame: During the procedure
Procedure-related satisfaction, as measured by Visual Analog Scale
Time frame: During the procedure
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 30 Aug 2016.
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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.
Kittipat Charoenkwan, MD principal investigator
Faculty of Medicine, Chiang Mai University
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 Cervical Intraepithelial Neoplasia, run by Chiang Mai University at 1 site in Thailand.
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 11 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 30 Aug 2016. 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 Thailand. 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?
Procedure-related pain, as measured by Visual Analog Scale (time frame: During the procedure). 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 30 Aug 2016.