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

January 8, 2017 updated by: Apinut Wongkietkachorn, Chulabhorn Hospital
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.

Study Overview

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

Interventional

Enrollment (Actual)

470

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 21, 2016

First Posted (Estimate)

December 26, 2016

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 8, 2017

Last Verified

January 1, 2017

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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