NCT03003091

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

December 20, 2016

Last Update Submit

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

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.

Other: Needs-based patient education

Traditional patient education

ACTIVE COMPARATOR

The participants received all structured information

Other: Traditional patient education

Interventions

Needs-based patient education
Traditional patient education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

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