NCT03807960

Brief Summary

This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

January 11, 2019

Last Update Submit

July 4, 2019

Conditions

Postoperative CareHysterectomyHealth Communication

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    Numeric rating scale (0 to 10) will be used for postoperative pain score

    At postoperative 24th hours.

Secondary Outcomes (5)

  • Postoperative analgesic consumption

    Up to the postoperative 24th hours.

  • PCA device usage

    During postoperative 24 hours

  • PCA device demand dose duration

    During postoperative 24hours

  • Patient's satisfaction

    At the postoperative 24th hours

  • The change of the postoperative pain score

    Up to the postoperative 24th hours.

Other Outcomes (1)

  • Length of stay hospital

    Up to the postoperative 10 days

Study Arms (3)

visual

EXPERIMENTAL

The video about patient controlled analgesia device (PCA) usage will shown to the patients via notebook.

Other: video

written

EXPERIMENTAL

The written form which include the same knowledge will give to the patient for reading.

Other: written form

control

OTHER

The anesthesiologist will describe the PCA usage as in the routine care to the control group patients.

Other: routine care

Interventions

written formOTHER

The written form which include PCA usage information.

written
videoOTHER

The video about PCA usage

visual
routine careOTHER

The routine description about PCA usage

control

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • Elective hysterectomy

You may not qualify if:

  • Opioid abuse or Chronic opioid usage
  • opioid allergy
  • obesity(BMI\>30)
  • psychiatric disease
  • more than American Anesthesiologist Score 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University Hospital

Tokat Province, Merkez, 60100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Serkan Karaman, MD

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor,MD

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 17, 2019

Study Start

February 1, 2019

Primary Completion

June 20, 2019

Study Completion

June 21, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

TU(1)