NCT05208580

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2024

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

2.3 years

First QC Date

October 3, 2021

Last Update Submit

June 14, 2022

Conditions

Preoperative Anxiety

Outcome Measures

Primary Outcomes (2)

  • Change in preoperative anxiety level the day before the surgery in study groups

    Preoperative anxiety level will be compared with the baseline anxiety level evaluated at 10-14 days before the surgery. Anxiety level will be evaluated using Depression, Anxiety and Stress Scale 21 (DASS-21). Each of 21 item in a scale is evaluated using Likert-type scoring system (0 to 3 points, where 0 - not present, 3 - very consistent). The higher the socre, the higher the level of anxiety (worse outcome)

    The day before the surgery

  • Change in preoperative anxiety and information level the day before the surgery in study groups

    Preoperative anxiety level will be compared with the baseline anxiety level evaluated at 10-14 days before the surgery. Anxiety and information levels will be evaluated using Amsterdam Preoperative Anxiety and Information Scale (APAIS). Scale consists of 6 questions (4 regarding anxiety and 2 regarding information about surgery and anesthesia). Each question is scored by five point Likert-type scale (1 to 5, where 1 - not at all, 5 - extremely). The higher the score, the higher the anxiety and need for information about surgery and anesthesia (worse outcome).

    The day before the surgery

Secondary Outcomes (5)

  • Satisfaction with medical services

    48 hours after discharge from the hospital

  • Postoperative recovery

    48 hours after discharge from the hospital

  • Postoperative well-being of the patient

    First 3 days of the postoperative period

  • Postoperative pain levels

    First 3 days of the postoperative period

  • Postoperative delirium

    First 3 days of the postoperative period

Other Outcomes (1)

  • Causes of preoperative anxiety

    Up to second postoperative week

Study Arms (3)

On-line education

EXPERIMENTAL

Virtual educational activities

Behavioral: Virtual education

Contact education

EXPERIMENTAL

Live educational classes

Behavioral: Contact education

Control group

NO INTERVENTION

Regular perioperative care without additional educational activities

Interventions

Virtual educationBEHAVIORAL

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

On-line education
Contact educationBEHAVIORAL

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

Contact education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • refusal to participate in the study
  • do not speak Lithuanian
  • do not pass the PHQ-2 depression screening test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

RECRUITING

Study Officials

  • Egle Kontrimaviciute, MD, PhD

    Vilnius University, Vilnius University Hospital Santaros Klinikos, Lithuania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Egle Kontrimaviciute, MD, PhD

CONTACT

+370 686 55860egle.kontrimaviciute@santa.lt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate professor at Vilnius University, Lithuania

Study Record Dates

First Submitted

October 3, 2021

First Posted

January 26, 2022

Study Start

January 31, 2022

Primary Completion

May 30, 2024

Study Completion

June 14, 2024

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations

LI(1)