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Clinical Trials/NCT05208580
NCT05208580
Unknown
N/A

Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

Vilnius University1 site in 1 country500 target enrollmentJanuary 31, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preoperative Anxiety
Sponsor
Vilnius University
Enrollment
500
Locations
1
Primary Endpoint
Change in preoperative anxiety level the day before the surgery in study groups
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2022
End Date
June 14, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Egle Kontrimaviciute

MD, PhD, Associate professor at Vilnius University, Lithuania

Vilnius University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)
  • Satisfaction with medical services(48 hours after discharge from the hospital)

Study Sites (1)

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