Music and Colposcopy in Women With Cervical Dysplasia.
Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.
1 other identifier
interventional
205
1 country
2
Brief Summary
To assess the effect of music during colposcopy on women´s anxiety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2016
CompletedFirst Posted
Study publicly available on registry
December 29, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2018
CompletedMay 8, 2018
May 1, 2018
1.2 years
December 25, 2016
May 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
10 minutes before and after colposcopy
Secondary Outcomes (7)
Anxiety score after colposcopy
10 minutes before and after colposcopy
Change in heart rate
10 minutes
Pain during examination
10 minutes
Pain after examination
10 minutes
general unpleasantness during examination
10 minutes
- +2 more secondary outcomes
Study Arms (2)
Music and colposcopy
EXPERIMENTALWomen will hear Mozarts symphony Nr. 40 during the colposcopic examination
Colposcopy without music
ACTIVE COMPARATORDuring the colposcopic examination women will not hear music
Interventions
Eligibility Criteria
You may qualify if:
- women referred for colposcopy due to cervical abnormalities
- We included women if they attended colposcopy for the first time
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Zydolab - Institute of Cytology and Immune Cytochemistry
Dortmund, North Rhine-Westphalia, 44137, Germany
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, 44625, Germany
Related Publications (1)
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.
PMID: 30204685DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziad Hilal, M.D.
Zydolab - Institute of Cytology and Immune Cytochemistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 25, 2016
First Posted
December 29, 2016
Study Start
February 1, 2017
Primary Completion
May 2, 2018
Study Completion
May 7, 2018
Last Updated
May 8, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share