Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

NCT ID: NCT05208580

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2024-06-14

Brief Summary

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The aim of the study is to investigate the effect of preoperative patient education on the level of properative anxiety and postoperative psychosocial outcomes. Participants will be assigned to one of the 3 study groups: on-line education, contact education and control (no preoperative education). The investigators will evaluate preoperative anxiety level at different time points (baseline at 2 weeks before the surgery, at the evening before the surgery and postoperatively) and investigate dynamics of anxiety in the perioperative period. Additional qualitative interview by psychologists will be performed to evaluate the potential causes of increased/decreased preoperative anxiety.

Impact on postoperative complications, well-being of the participant, quality of recovery and satisfaction with medical care will also be evaluated.

Detailed Description

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Conditions

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Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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On-line education

Virtual educational activities

Group Type EXPERIMENTAL

Virtual education

Intervention Type BEHAVIORAL

Participants undergo virtual education activities on an on-line platform 10-14 days before the surgery

Contact education

Live educational classes

Group Type EXPERIMENTAL

Contact education

Intervention Type BEHAVIORAL

Participants attend live educational classes 10-14 days before the surgery

Control group

Regular perioperative care without additional educational activities

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual education

Participants undergo virtual education activities on an on-line platform 10-14 days before the surgery

Intervention Type BEHAVIORAL

Contact education

Participants attend live educational classes 10-14 days before the surgery

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* agreement to participate in the study
* elective cholecystectomy or colon surgery

Exclusion Criteria

* refusal to participate in the study
* do not speak Lithuanian
* do not pass the PHQ-2 depression screening test
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role collaborator

Vilnius University

OTHER

Sponsor Role lead

Responsible Party

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Egle Kontrimaviciute

MD, PhD, Associate professor at Vilnius University, Lithuania

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Egle Kontrimaviciute, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vilnius University, Vilnius University Hospital Santaros Klinikos, Lithuania

Locations

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Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Site Status RECRUITING

Countries

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Lithuania

Central Contacts

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Egle Kontrimaviciute, MD, PhD

Role: CONTACT

+370 686 55860

Facility Contacts

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Egle Kontrimaviciute, MD, PhD

Role: primary

+370 686 55860

Vilma Kuzminskaite, MD

Role: backup

+370 636 24242

Other Identifiers

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2021/5-1351-823

Identifier Type: -

Identifier Source: org_study_id

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