Evaluation of the Psychosocial Impact on Health Professionals Exposed During COVID 19 Coronavirus Pandemic

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04752839
Collaborator
(none)
300
1
2.9
102.6

Study Details

Study Description

Brief Summary

Application of a survey in electronic support to hospital professionals. This survey will include different demographics as well as questions from own elaboration about the different aspects related to the development of work during the health emergency. A third part will be included different validated scales for screening / diagnosis of different problems that can present those who are working in the Current situation. The different scales are the PHQ-9, GAD 7, ISI, and EIE-R. These scales address the different problems that have been seen that can introduce professionals, Depression, Anxiety, Insomnia and adaptation to stressors.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of the Psychosocial Impact on Health Professionals Exposed During the COVID 19 Coronavirus Pandemic
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Exposed Workers

Workers who have been exposed during COVID 19 pandemic.

Outcome Measures

Primary Outcome Measures

  1. General Anxiety Disorder (GAD7) score. [Through study completion, an average of 1 year.]

    This instrument has been created to serve as a screening in anxiety disorder widespread. It is composed of 7 Likert-type response items from 0 to 3 that include the symptoms and the disability associated with the disorder.7 For its correction, a total score is obtained from the sum of scores of all the items, which can range from 0 to 21. There are no established cut-off points for the Spanish version. In the original version, the authors propose a cut-off point of greater than or equal to 10. The version validated for the Spanish population will be used.

  2. Insomnia severity Index (ISI) [Through study completion, an average of 1 year.]

    The investigators will use the adaptation of Fernández Mendoza et al. It is made up of 7 items that evaluate the nature, severity and impact of insomnia. It is answered with a Likert-type scale that goes from 0 to 4, taking into account the last month. For its correction, a total score is obtained that ranges between 0 and 28. The proposed cut-off points of the original version are: 0-7: no insomnia 8-14: insomnia below the threshold 15-21: clinical insomnia of moderate severity 22-28: severe clinical insomnia

  3. Patient Health Questionaire (PHQ-9) [Through study completion, an average of 1 year.]

    This instrument is intended to aid the diagnosis of depression through the DSM-IV criteria, and to determine the severity of said disorder. It can also be used to observe the changes experienced by patients over time. It is made up of 9 items with Likert-type responses with values between 0 and 3 that refer to the last two weeks. For its correction, a total score is obtained that ranges between 0 and 27. The proposed cut-off points are: 1-4: minimal depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression The version validated for the Spanish population will be used

  4. Perceived Stress Scale [Through study completion, an average of 1 year.]

    The Perceived Stress Scale provides an overall measure of perceived stress in the last month evaluating the degree to which life situations are valued as stressful by people. 12 Specifically: the degree of subjective control over unpredictable or unexpected situations and the discomfort that accompanies the perceived lack of control. Originally it consists of 14 items (some of which are formulated in negative). Two dimensions have been considered (control and loss of control) although more restrictive criteria would require considering the one-dimensionality of the scale. The validated Spanish version will be used.

  5. Impact of Event Scale Revised (IES-R) [Through study completion, an average of 1 year.]

    This scale is conceptually based on Horowitz's two-factor theory and assesses the subjective discomfort that accompanies traumatic experiences. It is a self-administered scale, and consists of 22 items in the revised version. 7 items value intrusion 8 avoidance and 7 hyperactivation. The investigators will evaluate the post-traumatic stress symptomatology, and for that, the revised version in Spanish will be used.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Workers during COVID 19 pandemic at Hospital de la Creu i Sant Pau
Exclusion Criteria:
  • No Exclusion Criteria, only the negative to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08041

Sponsors and Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT04752839
Other Study ID Numbers:
  • IIBSP-COV-2020-40
First Posted:
Feb 12, 2021
Last Update Posted:
Feb 12, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 12, 2021