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The effect of video information on anxiety levels in women attending colposcopy: A randomized controlled trial.

The effect of video information on anxiety levels in women attending colposcopy: A randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24406
Enrollment
128
Registered
2012-06-11
Start date
2012-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Stress, Abnormal cervical smear, Colposcopy, Video information.

Interventions

Group A will consist of patients who receive the standard information leaflet and additional video information before colposcopy. Meaning that the Pap smear result, the colposcopy, the possible treatm

Sponsors

Radboud University Nijmegen Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. New patient referred for colposcopy with an abnormal Pap smear result; 2. Signed informed consent; 3. Age 18 years or above; 4. Mentally capable to understand and comprehend the study and its implications; 5. Sufficient knowledge of the Dutch language to read and understand the information brochures and video, and to answer the questionnaires.

Exclusion criteria

Exclusion criteria: 1. A former referral for colposcopic evaluation due to an abnormal cervical smear result; 2. Pregnant women; 3. Women with mental impairment; 4. No signed informed consent; 5. Age below 18 years; 6. Insufficient knowledge of the Dutch language to understand the video, and to answer the questionnaires.

Design outcomes

Primary

MeasureTime frame
1. The scores on the Spielberger STATE and TRAIT Anxiety Iventory (STAI); the Hospital Anxiety and Depression scale (HADS); Visual Analog Score (VAS) and the SF12; 2. The effect of information on the anxiety, fear and quality of life among women with an abnormal Pap smear result.

Secondary

MeasureTime frame
1. Differences in scores of anxiety, depression, pain and quality of life questionnaires in and between group A and B; 2. Relations between demographic characteristics and questionnaire scores; 3. Cross relations between knowledge, satisfaction with information, anxiety, depression, perceiving pain, and quality of life in group A and B.

Contacts

Public ContactP.J.W. Ketelaars

Dept of obstetrics/gynecology 791 Radboud University Nijmegen Medical Centre P.O. Box 9101

pleun.ketelaars@gmail.com+31 (0)24 3613198

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)