Impact of the Different Information Channels in Reducing Anxiety in Participants of Cervical Cancer Screening

NCT ID: NCT05622760

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2022-12-28

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.

Conditions

Uterine Cervical Neoplasms; Early Detection of Cancer; Anxiety; Clinical Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Audiovisual information

Group of participants to whom the information is given through an audiovisual medium.

Group Type: EXPERIMENTAL

Audiovisual information

Intervention Type: OTHER

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.

Written information

Group of participants to whom the information is given through the writing that is available on the website of the health organization.

Group Type: PLACEBO_COMPARATOR

Written information

Intervention Type: OTHER

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)

Interventions

Audiovisual information

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.

Intervention Type: OTHER

Written information

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)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biogipuzkoa Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Del Valle, MD

Role: PRINCIPAL_INVESTIGATOR

Osakidetza

Locations

Donostia University Hospital

San Sebastián, Guipuzcoa, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 6668417 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16673626 (View on PubMed)

Other Identifiers

DICRA

Identifier Type: -

Identifier Source: org_study_id