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CompletedNCT03003091Updated Jan 10, 2017

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

An interventional study of Needs-based patient education and Traditional patient education in Educational Problems and Surgery, sponsored by Chulabhorn Hospital. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-10.

Sponsored by Chulabhorn Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
470
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Educational Problems
  • Surgery
03

In context

Lead sponsor

Chulabhorn Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years or older
  • scheduled for day surgery
  • willing to cooperate with the study

Exclusion criteria

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
470 participants (actual)

Study arms

  • 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.

    Other: Needs-based patient education

  • Active comparator
    Traditional patient education

    The participants received all structured information

    Other: Traditional patient education

Interventions

  • OtherNeeds-based patient education
  • OtherTraditional patient education
06

What researchers measure

Primary outcomes

  1. Patient anxiety before patient education (STAI)

    Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)

    Time frame: 1 day

  2. Patient anxiety before patient education (VAS)

    Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)

    Time frame: 1 day

  3. Patient anxiety after patient education (STAI)

    Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)

    Time frame: 1 day

  4. Patient anxiety after patient education (VAS)

    Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)

    Time frame: 1 day

  5. Patient anxiety after operation (STAI)

    Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)

    Time frame: 1 day

  6. Patient anxiety after operation (VAS)

    Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)

    Time frame: 1 day

Secondary outcomes

  1. Patient Satisfaction before patient education

    Patient satisfaction was measured by a 100 mm visual analogue scale.

    Time frame: 1 day

  2. Patient Satisfaction after patient education

    Patient satisfaction was measured by a 100 mm visual analogue scale.

    Time frame: 1 day

  3. Patient Satisfaction after surgery

    Patient satisfaction was measured by a 100 mm visual analogue scale.

    Time frame: 1 day

  4. Education time

    Time in patient education was recorded with stopwatch at the beginning to the end of patient education session

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Wongkietkachorn A, Wongkietkachorn N, Rhunsiri P. Preoperative Needs-Based Education to Reduce Anxiety, Increase Satisfaction, and Decrease Time Spent in Day Surgery: A Randomized Controlled Trial. World J Surg. 2018 Mar;42(3):666-674. doi: 10.1007/s00268-017-4207-0. PubMed 28875242 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2016, a primary completion of Sep 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2016
First posted
Dec 26, 2016
Start
Apr 2016
Primary completionActual
Sep 2016
CompletionActual
Dec 2016
Last update
Jan 10, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03003091
Lead sponsor
Chulabhorn Hospital
Responsible party
Apinut Wongkietkachorn (Doctor, Chulabhorn Hospital) — Principal investigator
First posted
Dec 26, 2016
Start date
Apr 2016
Primary completion
Sep 2016
Completion
Dec 2016
Last update
Jan 10, 2017
View the source record on ClinicalTrials.gov ↗

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