Clinical trial NCT05622760: Impact of the Different Information Channels in Reducing Anxiety in Participants of Cervical Cancer Screening
Official title: Audiovisual Informative Project for the Participants of the Cervical Cancer Screening in Osakidetza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Neoplasms
Early Detection of Cancer
Anxiety
Clinical Trial
Keywords: uterine cervical neoplasms
anxiety
early detection of cancer
uterine cervical cancer screening
cervical cancer screening
cervical cancer
clinical trial
audiovisual intervention
Lead sponsor: Biogipuzkoa Health Research Institute
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 140
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial on quality of life where there are 2 groups. After signing the informed consents and completing the anxiety surveys, each participant is randomized and given the corresponding envelope.
Primary purpose: OTHER

Brief summary: When participating in population-based screening for cervical cancer, women experience great anxiety during the weeks of waiting since they learn that they have an altered screening result until the colposcopy is performed. In this study we want to verify how anxiety decreases when the information is improved and an audiovisual support is added when giving it.

Detailed description: This study is designed as a double-blind clinical trial. Candidate patients for this study are women referred to a colposcopy consultation after an altered result of the screening test. Those women who have previously been in the colposcopy consultation or have had this test performed in a private center are excluded.

The initial recruitment is done by telephone. If they accept, they are given an appointment at the hospital one day where, after being informed again and signing the informed consent, they are randomized and assigned a group. There are 2 groups, in one they receive an envelope with the information in writing that was created in Osakidetza and is available on the website of said organization, and the other group receives a sheet with the links to the videos created for this study in the same envelope. In this way, both groups assume that they are receiving information and we avoid bias. The principal investigator is the one who carries out this phase and distributes the envelopes, but is unaware of their contents. Previously, a collaborator fills in the envelopes according to the randomization code and indicates outside the envelope the order in which they should be delivered. Only she knows the randomization code and she will not reveal it until the end of the study.

To analyze the level of anxiety, the participants will fill out 2 scales before receiving the information, and they will return them on the day of the colposcopy before performing it. The scales used are the Spielberger´s State-trait anxiety inventory (STAI) and the Cohen´s PerceivedStress Scale 14 (PSS14). The STAI scale has 40 items, scored from 0 (never) to 3 (very much) points. The final result can range between 0 and 60, higher scores are related to a higher level of anxiety. The PSS14 scale consists of 14 items with a five-point scale response format (0 is never and 4 is very often). The scale scores from 0 to 56; higher scores indicate higher perceived stress.

It will also be analyzed whether the waiting time until the colposcopy and the level of academic studies influence the level of anxiety. And the perception of the colposcopy will be analyzed, with the VAS scale, according to their level of anxiety and the way they received the information.

Eligibility criteria: Inclusion Criteria:

* Patients who participate in the Osakidetza cervical cancer screening program and are referred to the colposcopy consultation of the Hospital Universitario Donostia due to an altered screening test.

Exclusion Criteria:

* Patients who have previously been in the colposcopy consultation or have gone to a private center to receive information about their altered result or to undergo colposcopy.

Primary outcomes:
measure: Change in the level of anxiety measured by the STAI scale according to the information format
timeFrame: Less than 6 weeks between the call notifying the altered result and the colposcopy
measure: Change in the level of anxiety measured by the PSS14 scale according to the information format
timeFrame: Less than 6 weeks between the call notifying the altered result and the colposcopy
Secondary outcomes:
measure: Influence of waiting time for colposcopy on anxiety measured by the STAI scale
timeFrame: 6 weeks maxium
measure: Influence of waiting time for colposcopy on anxiety measured by the PSS14 scale
timeFrame: 6 weeks maxium
measure: Influence of academic level on anxiety measured by the STAI scale
timeFrame: 6 weeks maxium
measure: Influence of academic level on anxiety measured by the PSS14 scale
timeFrame: 6 weeks maxium
measure: Change in colposcopy pain perception according to anxiety level measured by the STAI scale
timeFrame: 6 weeks maxium
measure: Change in colposcopy pain perception according to anxiety level measured by the PSS14 scale
timeFrame: 6 weeks maxium
Other outcomes:
Locations:
city: San Sebastián
country: Spain
facility: Donostia University Hospital
state: Guipuzcoa
Study officials:
affiliation: Osakidetza
name: David Del Valle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
citation: Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.