Needs-Based Patient Education Versus Traditional Patient Education in Reducing Pre-operative Anxiety in Day Surgery
1 other identifier
interventional
470
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 20, 2016
CompletedFirst Posted
Study publicly available on registry
December 26, 2016
CompletedJanuary 10, 2017
January 1, 2017
5 months
December 20, 2016
January 8, 2017
Conditions
Outcome Measures
Primary Outcomes (6)
Patient anxiety before patient education (STAI)
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
1 day
Patient anxiety before patient education (VAS)
Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
1 day
Patient anxiety after patient education (STAI)
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
1 day
Patient anxiety after patient education (VAS)
Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
1 day
Patient anxiety after operation (STAI)
Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
1 day
Patient anxiety after operation (VAS)
Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
1 day
Secondary Outcomes (4)
Patient Satisfaction before patient education
1 day
Patient Satisfaction after patient education
1 day
Patient Satisfaction after surgery
1 day
Education time
1 day
Study Arms (2)
Needs-based patient education
EXPERIMENTALThe 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 COMPARATORThe participants received all structured information
Interventions
Eligibility Criteria
You may qualify if:
- years or older
- scheduled for day surgery
- willing to cooperate with the study
You may not qualify if:
- illegibility which could not answer questionnaire by themselves
- psychiatric diseases
- undergoing previous surgery within 6 months
- possibility to undergo major operation after day surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 28875242DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
December 20, 2016
First Posted
December 26, 2016
Study Start
April 1, 2016
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
January 10, 2017
Record last verified: 2017-01