An interventional study of Headphones and No Headphones in Uterine Cervical Dysplasia, sponsored by Zydolab - Institute of Cytology and Immune Cytochemistry. Completed at 2 sites in Germany. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-08.
Sponsored by Zydolab - Institute of Cytology and Immune Cytochemistry · Not applicable, Interventional, and Other
To assess the effect of music during colposcopy on women´s anxiety.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
This study's enrollment of 205 is above the median of 167 across 285 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Zydolab - Institute of Cytology and Immune Cytochemistry is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Women will hear Mozarts symphony Nr. 40 during the colposcopic examination
Device: Headphones
During the colposcopic examination women will not hear music
Other: No Headphones
Music can be heard through headphones
No Headphones will be used.
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.
Time frame: 10 minutes before and after colposcopy
Anxiety score after colposcopy
Each women completes the state anxiety questionnaire (state-trait anxiety inventory \[STAI\]) 10 minutes after colposcopy.
Time frame: 10 minutes before and after colposcopy
Change in heart rate
The difference in heart rate before and after colposcopy will be measured.
Time frame: 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').
Time frame: 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').
Time frame: 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").
Time frame: 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")
Time frame: 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").
Time frame: 10 minutes
Plan to share: No
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Zydolab - Institute of Cytology and Immune Cytochemistry