Educational ProblemsNCT03003091
Needs-Based Patient Education Versus Traditional Patient Education in Reducing Pre-operative Anxiety in Day Surgery
A study testing Needs-based patient education and Traditional patient education in people with Educational Problems and Surgery, run by Chulabhorn Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Educational Problems, Surgery
- What is being tested?
- Needs-based patient education and Traditional patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- scheduled for day surgery
- willing to cooperate with the study
Who cannot join
- illegibility which could not answer questionnaire by themselves
- psychiatric diseases
- undergoing previous surgery within 6 months
- possibility to undergo major operation after day surgery
About this study
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.
- Conditions
- Educational Problems, Surgery
- Being tested
- Needs-based patient education, Traditional patient education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needs-based patient educationOther
Traditional patient educationOther
| Study group | Role | What they receive |
|---|---|---|
| Needs-based patient education | Experimental | 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. Receives: Other: Needs-based patient education |
| Traditional patient education | Active comparator | The participants received all structured information Receives: Other: Traditional patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient anxiety before patient education (STAI)
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
Measured: 1 day
Patient anxiety before patient education (VAS)
Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
Measured: 1 day
Patient anxiety after patient education (STAI)
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
Measured: 1 day
Patient anxiety after patient education (VAS)
Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
Measured: 1 day
Patient anxiety after operation (STAI)
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
Measured: 1 day
Patient anxiety after operation (VAS)
Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
Measured: 1 day
Secondary outcomes (4)
Patient Satisfaction before patient education
Patient satisfaction was measured by a 100 mm visual analogue scale.
Measured: 1 day
Patient Satisfaction after patient education
Patient satisfaction was measured by a 100 mm visual analogue scale.
Measured: 1 day
Patient Satisfaction after surgery
Patient satisfaction was measured by a 100 mm visual analogue scale.
Measured: 1 day
Education time
Time in patient education was recorded with stopwatch at the beginning to the end of patient education session
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Educational ProblemsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulabhorn Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Apinut Wongkietkachorn, Chulabhorn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003091
- Sponsor's protocol ID
- Chulabhorn
- Status last verified
- Jan 2017
- First submitted
- 20 Dec 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needs-Based Patient Education Versus Traditional Patient Education in Reducing Pre-operative Anxiety in Day Surgery
- ClinicalTrials.gov ID
- NCT03003091
- Acronym / sponsor ID
- Chulabhorn
- Conditions
- Educational Problems, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Chulabhorn HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Dec 2016 (estimated)
- 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.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needs-based patient education | Experimental | Other: Needs-based patient educationThe 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. |
| Traditional patient education | Active comparator | Other: Traditional patient educationThe participants received all structured information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- scheduled for day surgery
- willing to cooperate with the study
Key exclusion criteria (4 listed)
- illegibility which could not answer questionnaire by themselves
- psychiatric diseases
- undergoing previous surgery within 6 months
- possibility to undergo major operation after day surgery
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 |
|---|---|---|
| Needs-based patient education | Other | Needs-based patient education |
| Traditional patient education | Other | Traditional patient education |
Primary outcome
Patient anxiety before patient education (STAI)
Time frame: 1 day
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
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)
Patient anxiety after patient education (STAI)
Time frame: 1 day
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
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)
Patient anxiety after operation (STAI)
Time frame: 1 day
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
Patient anxiety after operation (VAS)
Time frame: 1 day
Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
4 secondary outcomes
Patient Satisfaction before patient education
Time frame: 1 day
Patient Satisfaction after patient education
Time frame: 1 day
Patient Satisfaction after surgery
Time frame: 1 day
Education time
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Derived from this study: PubMed 28875242Wongkietkachorn 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Needs-based patient education and Traditional patient education in people with Educational Problems and Surgery, run by Chulabhorn Hospital.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient anxiety before patient education (STAI) (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003091, which also lists 1 linked publication.
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 10 Jan 2017.