Preoperative AnxietyNCT05208580
Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes
A study testing Virtual education and Contact education in people with Preoperative Anxiety, run by Vilnius University at 1 site in Lithuania.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Virtual education and Contact education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteLithuania
- Study dates
- 31 Jan 2022to 14 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- agreement to participate in the study
- elective cholecystectomy or colon surgery
Who cannot join
- refusal to participate in the study
- do not speak Lithuanian
- do not pass the PHQ-2 depression screening test
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
Egle Kontrimaviciute, MD, PhD, +370 686 55860, egle.kontrimaviciute@santa.lt
Vilma Kuzminskaite, MD, +370 636 24242, vilma.kuzminskaite@santa.lt
About this study
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.
- Conditions
- Preoperative Anxiety
- Being tested
- Virtual education, Contact education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual educationBehavioural
Participants undergo virtual education activities on an on-line platform 10-14 days before the surgery
Contact educationBehavioural
Participants attend live educational classes 10-14 days before the surgery
| Study group | Role | What they receive |
|---|---|---|
| On-line education | Experimental | Virtual educational activities Receives: Behavioral: Virtual education |
| Contact education | Experimental | Live educational classes Receives: Behavioral: Contact education |
| Control group | No intervention | Regular perioperative care without additional educational activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: The day before the surgery
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: First 3 days of the postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start31 Jan 2022
- Primary completion30 May 2024 (estimated)
- Study completion14 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Responsible party
- Principal investigator, Egle Kontrimaviciute, Vilnius University
- Investigators
- Egle Kontrimaviciute, MD, PhD, Principal investigator, Vilnius University, Vilnius University Hospital Santaros Klinikos, Lithuania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208580
- Sponsor's protocol ID
- 2021/5-1351-823
- Status last verified
- Jun 2022
- First submitted
- 3 Oct 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Education on Preoperative Anxiety and Postoperative Psychosocial Outcomes
- ClinicalTrials.gov ID
- NCT05208580
- Acronym / sponsor ID
- 2021/5-1351-823
- Conditions
- Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 14 Jun 2024 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| On-line education | Experimental | Behavioral: Virtual educationVirtual educational activities |
| Contact education | Experimental | Behavioral: Contact educationLive educational classes |
| Control group | No intervention | –Regular perioperative care without additional educational activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- agreement to participate in the study
- elective cholecystectomy or colon surgery
Key exclusion criteria (3 listed)
- refusal to participate in the study
- do not speak Lithuanian
- do not pass the PHQ-2 depression screening test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual educationParticipants undergo virtual education activities on an on-line platform 10-14 days before the surgery | Behavioural | On-line education |
| Contact educationParticipants attend live educational classes 10-14 days before the surgery | Behavioural | Contact education |
Primary outcome
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).
5 secondary outcomes
Satisfaction with medical services
Time frame: 48 hours after discharge from the hospital
Postoperative recovery
Time frame: 48 hours after discharge from the hospital
Postoperative well-being of the patient
Time frame: First 3 days of the postoperative period
Postoperative pain levels
Time frame: First 3 days of the postoperative period
Postoperative delirium
Time frame: First 3 days of the postoperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egle Kontrimaviciute, MD, PhD principal investigator
Vilnius University, Vilnius University Hospital Santaros Klinikos, Lithuania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual education and Contact education in people with Preoperative Anxiety, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Egle Kontrimaviciute, MD, PhD (+370 686 55860, egle.kontrimaviciute@santa.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in preoperative anxiety level the day before the surgery in study groups (time frame: The day before the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.