|- candidate number||12884|
|- NTR Number||NTR3472|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jun-2012|
|- Secondary IDs||2007/072 / NL17056.091.07; METC / CCMO|
|- Public Title||The effect of video information on anxiety levels in women attending colposcopy: A randomized controlled trial.|
|- Scientific Title||The effect of video information on anxiety levels in women attending colposcopy: A randomized controlled trial.|
|- ACRONYM||Colposcopy-fear study|
|- hypothesis||This study will be conducted to see whether providing video information on an individuel level reduces fear and stress in women with an abnormal cervical smear result referred to the colposcopy clinic.|
|- Healt Condition(s) or Problem(s) studied||Anxiety, Stress, Abnormal cervical smear, Colposcopy, Video|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2012|
|- planned closingdate||1-jul-2014|
|- Target number of participants||128|
|- 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 treatment, and some of the matters that surround will be explained by a gynecologist. Also, the hospital, the department, reception desk, room and examination will be showed in this video.
Group B will consist of patients who receive only the standard information leaflet on the Pap smear result, the colposcopy and the possible treatment. The means of the study will be explained by phone. No verbal information will be given during this phone call on medical issues.
|- Primary outcome||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 outcome||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.
|- Timepoints||T0: After informed consent, alle participating patients are requested to fill out all questionnaires;|
T1: Before colposcopy all patients are requested to fill out all questionnaires;
T2: After colposcopy all patients are requested to fill out all questionnaires.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. P.J.W. Ketelaars|
|- CONTACT for SCIENTIFIC QUERIES||Drs. P.J.W. Ketelaars|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Publications||"The role of individually targeted information to reduce anxiety before colposcopy: a randomised controlled trial" |
RP de Bie, LFAG Massuger, CH Lenselink et al.
|- Brief summary||Rationale:|
An abnormal Pap smear result can affect a woman's life in a negative manner. Women do not anticipate abnormal smear results and are taken by surprise. It frequently results in fear of cancer and worries about fertility. Further, women have uncertainty about what is going to happen and what the colposcopic procedure entails. In order to reach the greatest benefit from the screening programme, it seems to be important to decrease the fear and anxiety, and to improve information supply. These anxiety levels before primary colposcopy are not reduced by individually targeted information. There is little information that video information will reduce anxiety levels before colposcopy.
This study will be conducted to evaluate whether providing video information before colposcopy reduces fear in women with an abnormal cervical smear result referred to the colposcopy clinic.
Randomized controlled trial.
The study population will consist of all new patients, 18 years and older, who are referred for colposcopic evaluation due to an abnormal Pap smear result.
One group will consist of patients who receive the standard information leaflet and additional video information. The control group will consist of patients who will only receive the standard information leaflet.
Main study parameters:
The effect of information on the anxiety, fear, quality of life and pain among women with an abnormal Pap smear result. The differences in scores of anxiety, depression, quality of life and pain among women with an abnormal Pap smear result. The differences in scores of anxiety, depression, quality of life and pain between group A and B.
|- Main changes (audit trail)|
|- RECORD||11-jun-2012 - 23-jun-2012|