Needs-Based Patient Education Versus Traditional Patient Education in Reducing Pre-operative Anxiety in Day Surgery

Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003091
• Other study ID #: Chulabhorn
• Status: Completed
• Phase: N/A
• First received: December 20, 2016
• Last updated: January 8, 2017
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Chulabhorn Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

In patient education, the amount of information that is not proper with the individual patient, such as too much or too little, can increase anxiety to patient. Needs-based patient education has been developed to determine the proper amount of information and provide the education based on patient needs. This study aims to compare needs-based patient education to traditional patient education in how they affect preoperative anxiety and patient satisfaction.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Educational Problems
• Surgery

Intervention

Other:
• Needs-based patient education

• Traditional patient education

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulabhorn Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient anxiety before patient education (STAI)	Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)	1 day	Yes
Primary	Patient anxiety before patient education (VAS)	Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)	1 day	Yes
Primary	Patient anxiety after patient education (STAI)	Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)	1 day	Yes
Primary	Patient anxiety after patient education (VAS)	Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)	1 day	Yes
Primary	Patient anxiety after operation (STAI)	Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)	1 day	Yes
Primary	Patient anxiety after operation (VAS)	Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)	1 day	Yes
Secondary	Patient Satisfaction before patient education	Patient satisfaction was measured by a 100 mm visual analogue scale.	1 day	Yes
Secondary	Patient Satisfaction after patient education	Patient satisfaction was measured by a 100 mm visual analogue scale.	1 day	Yes
Secondary	Patient Satisfaction after surgery	Patient satisfaction was measured by a 100 mm visual analogue scale.	1 day	Yes
Secondary	Education time	Time in patient education was recorded with stopwatch at the beginning to the end of patient education session	1 day	Yes