Information for Patient Controlled Analgesia Device

The Effect of Visual and Written Information Tools on Patient Controlled Analgesia Device Usage

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

Study Overview

• Status: Completed
• Conditions: Postoperative Care; Hysterectomy; Health Communication
• Intervention / Treatment: Other: video; Other: written form; Other: routine care

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

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Tokat, Merkez, Turkey, 60100
      • Gaziosmanpasa University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: visual; The video about patient controlled analgesia device (PCA) usage will shown to the patients via notebook.	Other: video; The video about PCA usage
Experimental: written; The written form which include the same knowledge will give to the patient for reading.	Other: written form; The written form which include PCA usage information.
Other: control; The anesthesiologist will describe the PCA usage as in the routine care to the control group patients.	Other: routine care; The routine description about PCA usage

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	During postoperative 24 hours
PCA device demand dose duration	The duration of the patients' demanding dose	During postoperative 24hours
Patient's satisfaction	The numeric rating scale (0 to 10) will be used. In this scale 0 will be the worst, 10 will be the best satisfaction.	At the postoperative 24th hours
The change of the postoperative pain score	Numeric rating scale (0 to 10) will be used to evaluate the pain score. The change in this score during postoperative 24 hours will be calculated.(the first score will be extracted from the last score)	Up to the postoperative 24th hours.

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tuğba Karaman
• Collaborators: Tokat Gaziosmanpasa University
• Investigators: Principal Investigator: Serkan Karaman, MD, Gaziosmanpasa University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): June 21, 2019

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: pcı

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No