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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05208580
Other study ID # 2021/5-1351-823
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 31, 2022
Est. completion date June 14, 2024

Study information

Verified date June 2022
Source Vilnius University
Contact Egle Kontrimaviciute, MD, PhD
Phone +370 686 55860
Email egle.kontrimaviciute@santa.lt
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date June 14, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual education
Participants undergo virtual education activities on an on-line platform 10-14 days before the surgery
Contact education
Participants attend live educational classes 10-14 days before the surgery

Locations

Country Name City State
Lithuania Vilnius University Hospital Santaros Klinikos Vilnius

Sponsors (2)

Lead Sponsor Collaborator
Vilnius University Vilnius University Hospital Santaros Klinikos

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Other Causes of preoperative anxiety Qualitative interview performed by trained psychologists to evaluate potential causes of preoperative increased/decreased anxiety Up to second postoperative week
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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