Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

Study Overview
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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.

Official Title
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Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

Conditions
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Preoperative Anxiety

Intervention / Treatment
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* Behavioral: Virtual education
* Behavioral: Contact education


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: On-line education<br>Virtual educational activities | Behavioral: Virtual education<br>* Participants undergo virtual education activities on an on-line platform 10-14 days before the surgery<br>|
| Experimental: Contact education<br>Live educational classes | Behavioral: Contact education<br>* Participants attend live educational classes 10-14 days before the surgery<br>|
| No Intervention: Control group<br>Regular perioperative care without additional educational activities | |

What is the study measuring?
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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 |