Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Preoperative Anxiety
• Intervention / Treatment: Behavioral: Virtual education; Behavioral: Contact education

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Egle Kontrimaviciute, MD, PhD; Phone Number: +370 686 55860; Email: egle.kontrimaviciute@santa.lt

Study Locations

• Lithuania
  • Vilnius, Lithuania, 08661
    • Recruiting
    • Vilnius University hospital Santaros klinikos
    • Contact: Egle Kontrimaviciute, MD, PhD; Phone Number: +370 686 55860; Email: egle.kontrimaviciute@santa.lt
    • Contact: Vilma Kuzminskaite, MD; Phone Number: +370 636 24242; Email: vilma.kuzminskaite@santa.lt
    • Principal Investigator: Egle Kontrimaviciute, MD, PhD
    • Sub-Investigator: Vilma Kuzminskaite, MD
    • Sub-Investigator: Tomas Poskus, MD, PhD
    • Sub-Investigator: Alfredas Laurinavicius, MD, PhD
    • Sub-Investigator: Marius Kryzauskas, MD
    • Sub-Investigator: Simonas Uselis, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: On-line education; Virtual educational activities	Behavioral: Virtual education; Participants undergo virtual education activities on an on-line platform 10-14 days before the surgery
EXPERIMENTAL: Contact education; Live educational classes	Behavioral: Contact education; Participants attend live educational classes 10-14 days before the surgery
NO_INTERVENTION: Control group; Regular perioperative care without additional educational activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with medical services	Evaluated using Hospital Consumer Assessment of Healthcare Providers and Systems questionnaire. Questionnaire consists of 29 questions about the recent hospital stay. Higher score - better satisfaction with medical care (better outcome).	48 hours after discharge from the hospital
Postoperative recovery	Evaluated using Quality of Recovery - 40 questionnaire. Questions are divided into part A and B. Each item in a questionnaire is evaluated by five point Likert-typescale (1 to 5, where 1 - never, 5 - all the time). Higher score accounts for more positive postoperative recovery process (better outcome).	48 hours after discharge from the hospital
Postoperative well-being of the patient	Subjective evaluation of well-being based on numerical scale 1 to 10 (1 - terrible, 10 - excellent) points. The higher the score, the better the outcome (postoperative well-being).	First 3 days of the postoperative period
Postoperative pain levels	Evaluated using 11-point Numerical Pain Scale (0 - no pain, 10 - worst imaginable pain). Higher scores mean worse postoperative pain (worse outcome).	First 3 days of the postoperative period
Postoperative delirium	Screening of delirium using Nursing Delirium Screening Scale. Includes 5 items, each is evaluated by 0 to 2 points. If the participant scores 2 points or more, the diagnosis of delirium is delivered.	First 3 days of the postoperative period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Causes of preoperative anxiety	Qualitative interview performed by trained psychologists to evaluate potential causes of preoperative increased/decreased anxiety	Up to second postoperative week

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: Vilnius University Hospital Santaros Klinikos
• Investigators: Principal Investigator: Egle Kontrimaviciute, MD, PhD, Vilnius University, Vilnius University Hospital Santaros Klinikos, Lithuania

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 31, 2022
• Primary Completion (ANTICIPATED): May 30, 2024
• Study Completion (ANTICIPATED): June 14, 2024

Study Registration Dates

• First Submitted: October 3, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (ACTUAL): January 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2021/5-1351-823

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No