Uterine Cervical DysplasiaNCT03005795
Music and Colposcopy in Women With Cervical Dysplasia.
A study testing Headphones and No Headphones in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 2 sites in Germany.
Trial summary
To assess the effect of music during colposcopy on women´s anxiety. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Uterine Cervical Dysplasia
- What is being tested?
- Headphones and No Headphones
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Feb 2017to 7 May 2018
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women referred for colposcopy due to cervical abnormalities
- We included women if they attended colposcopy for the first time
Who cannot join
- pregnant women
- presence of a language barrier
- known anxiety disorder or depression
- history of conization or other treatments on the cervix uteri
- known oncological disorder
- auditory defect
- cardiovascular disease
- inadequate colposcopy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Zydolab - Institute of Cytology and Immune Cytochemistry
Dortmund, North Rhine-Westphalia, 44137
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625
About this study
Official title: Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.
To assess the effect of music during colposcopy on women´s anxiety.
- Conditions
- Uterine Cervical Dysplasia
- Being tested
- Headphones, No Headphones
- Keywords
- cervical dysplasia, colposcopy, anxiety, music, mozart, randomized controlled trial
- Medical subject headings
- Uterine Cervical Dysplasia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeadphonesDevice
Music can be heard through headphones
No HeadphonesOther
No Headphones will be used.
| Study group | Role | What they receive |
|---|---|---|
| Music and colposcopy | Experimental | Women will hear Mozarts symphony Nr. 40 during the colposcopic examination Receives: Device: Headphones |
| Colposcopy without music | Active comparator | During the colposcopic examination women will not hear music Receives: Other: No Headphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety scores
Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes before and 10 minutes after colposcopy. The difference in scores before and after colposcopy will be measured.
Measured: 10 minutes before and after colposcopy
Secondary outcomes (7)
Anxiety score after colposcopy
Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes after colposcopy.
Measured: 10 minutes before and after colposcopy
Change in heart rate
The difference in heart rate before and after colposcopy will be measured.
Measured: 10 minutes
Pain during examination
women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').
Measured: 10 minutes
Pain after examination
women scores their pain level using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 (,no pain') to 10 (,worst imaginable pain').
Measured: 10 minutes
general unpleasantness during examination
women scores their feeeling during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("not at all unpleasant") to 10 ("extremely unpleasant").
Measured: 10 minutes
Anxiety during examination
women scores their anxiety during colposcopy using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("no anxiety at all") to 10 ("worst imaginable anxiety")
Measured: 10 minutes
Overall Satisfaction
women scores their satisfaction using a horizontal 100-mm visual analogue scale (VAS) ranging from 0 ("maximally unsatisfied") to 10 ("maximally satisfied").
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start1 Feb 2017
- Primary completion2 May 2018
- Study completion7 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical DysplasiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydolab - Institute of Cytology and Immune Cytochemistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ziad Hilal, M.D., Principal investigator, Zydolab - Institute of Cytology and Immune Cytochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005795
- Sponsor's protocol ID
- COLPO-3
- Status last verified
- May 2018
- First submitted
- 25 Dec 2016
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hilal Z, Alici F, Tempfer CB, Rath K, Nar K, Rezniczek GA. Mozart for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2018 Oct;132(4):1047-1055. doi: 10.1097/AOG.0000000000002876.
PubMed 30204685
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03005795
- Acronym / sponsor ID
- COLPO-3
- Conditions
- Uterine Cervical Dysplasia
- Keywords
- cervical dysplasia, colposcopy, anxiety, music, mozart, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Zydolab - Institute of Cytology and Immune CytochemistryUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 7 May 2018 (actual)
- First posted
- 29 Dec 2016 (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 assess the effect of music during colposcopy on women´s anxiety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music and colposcopy | Experimental | Device: HeadphonesWomen will hear Mozarts symphony Nr. 40 during the colposcopic examination |
| Colposcopy without music | Active comparator | Other: No HeadphonesDuring the colposcopic examination women will not hear music |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women referred for colposcopy due to cervical abnormalities
- We included women if they attended colposcopy for the first time
Key exclusion criteria (8 listed)
- pregnant women
- presence of a language barrier
- known anxiety disorder or depression
- history of conization or other treatments on the cervix uteri
- known oncological disorder
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 |
|---|---|---|
| HeadphonesMusic can be heard through headphones | Device | Music and colposcopy |
| No HeadphonesNo Headphones will be used. | Other | Colposcopy without music |
Primary outcome
Change in anxiety scores
Time frame: 10 minutes before and after colposcopy
Each women completes the state anxiety questionnaire (state-trait anxiety inventory [STAI]) 10 minutes before and 10 minutes after colposcopy. The difference in scores before and after colposcopy will be measured.
7 secondary outcomes
Anxiety score after colposcopy
Time frame: 10 minutes before and after colposcopy
Change in heart rate
Time frame: 10 minutes
Pain during examination
Time frame: 10 minutes
Pain after examination
Time frame: 10 minutes
general unpleasantness during examination
Time frame: 10 minutes
Anxiety during examination
Time frame: 10 minutes
Overall Satisfaction
Time frame: 10 minutes
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 8 May 2018.
- Derived from this study: PubMed 30204685Hilal Z, Alici F, Tempfer CB, Rath K, Nar K, Rezniczek GA. Mozart for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2018 Oct;132(4):1047-1055. doi: 10.1097/AOG.0000000000002876.
- Individual participant dataSharing planned: No
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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.
Ziad Hilal, M.D. principal investigator
Zydolab - Institute of Cytology and Immune Cytochemistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headphones and No Headphones in people with Uterine Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 2 sites in Germany.
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 2 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: finished, as of the sponsor's last update on 8 May 2018. 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 Germany. 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 anxiety scores (time frame: 10 minutes before and after colposcopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005795, which also lists 1 linked publication.
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 8 May 2018.