Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

Not Applicable

• Conditions: Preoperative Anxiety
• Interventions: Behavioral: Contact education; Behavioral: Virtual education

• Registration Number: NCT05208580
• Lead Sponsor: Vilnius University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-03
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Study Start: 2022-01-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-15
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contact education	Contact education	Live educational classes
On-line education	Virtual education	Virtual educational activities

Primary Outcome Measures

Name	Time	Method
Change in preoperative anxiety level the day before the surgery in study groups	The day before the surgery	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)
Change in preoperative anxiety and information level the day before the surgery in study groups	The day before the surgery	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).

Secondary Outcome Measures

Name	Time	Method
Postoperative recovery	48 hours after discharge from the hospital	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).
Postoperative well-being of the patient	First 3 days of the postoperative period	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).
Postoperative pain levels	First 3 days of the postoperative period	Evaluated using 11-point Numerical Pain Scale (0 - no pain, 10 - worst imaginable pain). Higher scores mean worse postoperative pain (worse outcome).
Postoperative delirium	First 3 days of the postoperative period	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.
Satisfaction with medical services	48 hours after discharge from the hospital	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).

Trial Locations

Locations (1)

Vilnius University Hospital Santaros Klinikos; 🇱🇹 Vilnius, Lithuania