Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

Preoperative Anxiety Clinical Trial

Official title:

Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208580
• Other study ID #: 2021/5-1351-823
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Preoperative Anxiety

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