Impact of the Different Information Channels in Reducing Anxiety in Participants of Cervical Cancer Screening
Condition: Uterine Cervical Neoplasms; Early Detection of Cancer; Anxiety; Clinical Trial
MeSH terms: Uterine Cervical Neoplasms; Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): Audiovisual information; Written information
Intervention type(s): Other; Other
Intervention description(s): The information provided to this group is in audiovisual format. This information is what has been designed with the aim of reducing the level of anxiety of patients who participate in cervical cancer screening.; The information provided to this group is in written format. This information is what is distributed to patients in the midwife's consultation and is available on the website of the health organization (Osakidetza)
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: uterine cervical neoplasms; anxiety; early detection of cancer; uterine cervical cancer screening; cervical cancer screening; cervical cancer; clinical trial; audiovisual intervention