Information for Patient Controlled Analgesia Device | NCT03807960

Studies
Information for Patient Controlled Analgesia Device

NCT03807960

Sponsor

Tuğba Karaman

Status

Completed

Last Update Posted

Jul 8, 2019Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Postoperative Care
Hysterectomy
Health Communication

Interventions

written form
video
routine care

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Jun 20, 2019Actual

Completion Date

Jun 21, 2019Actual

First Submitted Date

Jan 11, 2019

First Submission Date that Met QC Criteria

Jan 16, 2019

First Posted Date

Jan 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2019

Last Update Posted Date

Jul 8, 2019Actual

Name	Class
Tokat Gaziosmanpasa University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Postoperative pain is still a challenge for anesthesiologist. Patient controlled analgesia is an effective method for postoperative pain management. However, most of the patient can not use the device properly. The important cause of inabilities about device usage is insufficient information.In the patient information, visual, oral or written communication methods can be chosen. However, which method is suitable for our patient group is not clear.This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
written form	Other	The written form which include PCA usage information.	written

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Score	Numeric rating scale (0 to 10) will be used for postoperative pain score	At postoperative 24th hours.

Secondary Outcomes

Measure	Description	Time Frame
Postoperative analgesic consumption	Total opioid dosage will be recorded	Up to the postoperative 24th hours.
PCA device usage	The number of demand dose

Other Outcomes

Measure	Description	Time Frame
Length of stay hospital	Number of the day that patients stay at hospital will be recorded.	Up to the postoperative 10 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed consent
Elective hysterectomy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Serkan Karaman, MD	Gaziosmanpasa University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa University Hospital		Tokat Province	Merkez	60100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014743	Videotape Recording

Ancestor Terms

ID	Term
D013637	Tape Recording
D001296	Audiovisual Aids
D018961	Educational Technology
D013672	Technology

Browse Leaves

Not provided

Browse Branches

Not provided