ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03005795
Date of registration:	25/12/2016
Prospective Registration:	Yes
Primary sponsor:	Zydolab - Institute of Cytology and Immune Cytochemistry
Public title:	Music and Colposcopy in Women With Cervical Dysplasia.
Scientific title:	Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.
Date of first enrolment:	February 1, 2017
Target sample size:	205
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03005795
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Germany

Contacts

Name:	Ziad Hilal, M.D.
Address:
Telephone:
Email:
Affiliation:	Zydolab - Institute of Cytology and Immune Cytochemistry

Key inclusion & exclusion criteria

Inclusion Criteria:

- women referred for colposcopy due to cervical abnormalities

- We included women if they attended colposcopy for the first time

Exclusion Criteria:

- 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Uterine Cervical Dysplasia

Intervention(s)

Device: Headphones

Other: No Headphones

Primary Outcome(s)

Change in anxiety scores [Time Frame: 10 minutes before and after colposcopy]

Secondary Outcome(s)

Overall Satisfaction [Time Frame: 10 minutes]

Change in heart rate [Time Frame: 10 minutes]

Pain during examination [Time Frame: 10 minutes]

Anxiety score after colposcopy [Time Frame: 10 minutes before and after colposcopy]

general unpleasantness during examination [Time Frame: 10 minutes]

Anxiety during examination [Time Frame: 10 minutes]

Pain after examination [Time Frame: 10 minutes]

Secondary ID(s)

COLPO-3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.