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Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

Primary Purpose

Preoperative Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Virtual education
Contact education
Sponsored by
Vilnius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preoperative Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vilnius University Hospital Santaros KlinikosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

On-line education

Contact education

Control group

Arm Description

Virtual educational activities

Live educational classes

Regular perioperative care without additional educational activities

Outcomes

Primary Outcome Measures

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)
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).

Secondary Outcome Measures

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).
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).
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).
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).
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.

Full Information

First Posted
October 3, 2021
Last Updated
June 14, 2022
Sponsor
Vilnius University
Collaborators
Vilnius University Hospital Santaros Klinikos
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1. Study Identification

Unique Protocol Identification Number
NCT05208580
Brief Title
Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes
Official Title
Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
June 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vilnius University
Collaborators
Vilnius University Hospital Santaros Klinikos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
On-line education
Arm Type
Experimental
Arm Description
Virtual educational activities
Arm Title
Contact education
Arm Type
Experimental
Arm Description
Live educational classes
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Regular perioperative care without additional educational activities
Intervention Type
Behavioral
Intervention Name(s)
Virtual education
Intervention Description
Participants undergo virtual education activities on an on-line platform 10-14 days before the surgery
Intervention Type
Behavioral
Intervention Name(s)
Contact education
Intervention Description
Participants attend live educational classes 10-14 days before the surgery
Primary Outcome Measure Information:
Title
Change in preoperative anxiety level the day before the surgery in study groups
Description
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)
Time Frame
The day before the surgery
Title
Change in preoperative anxiety and information level the day before the surgery in study groups
Description
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).
Time Frame
The day before the surgery
Secondary Outcome Measure Information:
Title
Satisfaction with medical services
Description
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).
Time Frame
48 hours after discharge from the hospital
Title
Postoperative recovery
Description
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).
Time Frame
48 hours after discharge from the hospital
Title
Postoperative well-being of the patient
Description
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).
Time Frame
First 3 days of the postoperative period
Title
Postoperative pain levels
Description
Evaluated using 11-point Numerical Pain Scale (0 - no pain, 10 - worst imaginable pain). Higher scores mean worse postoperative pain (worse outcome).
Time Frame
First 3 days of the postoperative period
Title
Postoperative delirium
Description
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.
Time Frame
First 3 days of the postoperative period
Other Pre-specified Outcome Measures:
Title
Causes of preoperative anxiety
Description
Qualitative interview performed by trained psychologists to evaluate potential causes of preoperative increased/decreased anxiety
Time Frame
Up to second postoperative week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Egle Kontrimaviciute, MD, PhD
Phone
+370 686 55860
Email
egle.kontrimaviciute@santa.lt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egle Kontrimaviciute, MD, PhD
Organizational Affiliation
Vilnius University, Vilnius University Hospital Santaros Klinikos, Lithuania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Egle Kontrimaviciute, MD, PhD
Phone
+370 686 55860
Email
egle.kontrimaviciute@santa.lt
First Name & Middle Initial & Last Name & Degree
Vilma Kuzminskaite, MD
Phone
+370 636 24242
Email
vilma.kuzminskaite@santa.lt
First Name & Middle Initial & Last Name & Degree
Egle Kontrimaviciute, MD, PhD
First Name & Middle Initial & Last Name & Degree
Vilma Kuzminskaite, MD
First Name & Middle Initial & Last Name & Degree
Tomas Poskus, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alfredas Laurinavicius, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marius Kryzauskas, MD
First Name & Middle Initial & Last Name & Degree
Simonas Uselis, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes

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