- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03003091
Needs-Based Patient Education Versus Traditional Patient Education in Reducing Pre-operative Anxiety in Day Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preoperative anxiety can compromise surgical outcome. Anxiety increases serum cortisol, adrenaline, and noradrenaline. This results in postoperative pain, increased postoperative analgesic requirements, prolonged hospital stay and patient dissatisfaction. However, this anxiety can be reduced.
Patient education has been widely used to reduce operative anxiety; however, some patients have more anxiety after patient education. This incident could be explained by different individual's coping styles that patients use to deal with their anxiety. There are four major coping style: vigilant, avoidant, fluctuating, and flexible. Vigilant coper desires extended information to reduce anxiety. Avoidant coper desires minimal amount of information as too much will cause anxiety. Fluctuating coper generally desires small amount of information but desires greater detail in certain area. Flexible coper is able to adapt to whatever information available. Thus, if patient education with extended information is given to patients with avoidant coping style, they will have more anxiety. One study found that avoidant coping style is 31% of surgical patients in the study population. This is also supported by another study that one-third of patients reported to be worried after receiving an informative booklet. Therefore, to be able to deal with all types of coping style, patient education with different levels of information regarding patient needs is proposed to be developed.
Needs-based patient education has become more promising with increased supporting literature. It uses the principle of shared decision making, which is the pinnacle of patient-centered care. Needs-based patient education is also consistent with adult learning theory, which learning should be matched with different individual background and needs. A randomized controlled trial was conducted to compare needs-based patient education with traditional patient education in rheumatoid arthritis and found a superior result. However, there is still lack of evidence in using needs-based patient education in surgery.
This study evaluates needs-based patient education in reducing preoperative anxiety. To assess patient needs, a questionnaire is used as a tool. After receiving completed questionnaire, the physician provides information based on patient needs. Not only patients will benefit from this questionnaire but also physicians. The questionnaire enables physician to cut unnecessary information and pay more attention to the fact that patients need. Less information needed is less time spent in patient education session. As the most important reason why patient education is omitted is shortness of time. This needs-based patient education can contribute tremendously to the way we educate surgical patients.
Objectives This study aims to compare needs-based patient education to traditional patient education in how they affect preoperative anxiety, patient satisfaction, and time consumption.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older
- scheduled for day surgery
- willing to cooperate with the study
Exclusion Criteria:
- illegibility which could not answer questionnaire by themselves
- psychiatric diseases
- undergoing previous surgery within 6 months
- possibility to undergo major operation after day surgery
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Needs-based patient education
The participants received self-administered questionnaire to choose what topics they wanted to know and how much information they would like to know.
After completing the questionnaire, the participants submit the questionnaire to their physicians (investigators).
The surgeon then provided patient education based on participant needs.
|
|
Active Comparator: Traditional patient education
The participants received all structured information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient anxiety before patient education (STAI)
Time Frame: 1 day
|
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
|
1 day
|
Patient anxiety before patient education (VAS)
Time Frame: 1 day
|
Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
|
1 day
|
Patient anxiety after patient education (STAI)
Time Frame: 1 day
|
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
|
1 day
|
Patient anxiety after patient education (VAS)
Time Frame: 1 day
|
Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
|
1 day
|
Patient anxiety after operation (STAI)
Time Frame: 1 day
|
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
|
1 day
|
Patient anxiety after operation (VAS)
Time Frame: 1 day
|
Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction before patient education
Time Frame: 1 day
|
Patient satisfaction was measured by a 100 mm visual analogue scale.
|
1 day
|
Patient Satisfaction after patient education
Time Frame: 1 day
|
Patient satisfaction was measured by a 100 mm visual analogue scale.
|
1 day
|
Patient Satisfaction after surgery
Time Frame: 1 day
|
Patient satisfaction was measured by a 100 mm visual analogue scale.
|
1 day
|
Education time
Time Frame: 1 day
|
Time in patient education was recorded with stopwatch at the beginning to the end of patient education session
|
1 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Chulabhorn
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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