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Clinical Trials/NCT04850586
NCT04850586
Completed
N/A

The Impact of Structured Education Given by a Multidisciplinary Team on Pain, Anxiety, and Activities of Daily Living in Patients Undergoing Laparoscopic Cholecystectomy

Saglik Bilimleri Universitesi1 site in 1 country60 target enrollmentMarch 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
Saglik Bilimleri Universitesi
Enrollment
60
Locations
1
Primary Endpoint
The difference in pain scores measured by Visual Analog Scale between the two groups
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

It is well-known that pre-operative education has a positive effect on patient recovery. This study was conducted to evaluate the impact of structured education given by a multidisciplinary team (surgeon, anesthesiologist, and nurse) on pain, anxiety, and activities of daily living in patients undergoing laparoscopic cholecystectomy.

Detailed Description

In this randomized controlled study was conducted with 60 patients undergoing elective laparoscopic cholecystectomy in a training and research hospital in Turkey between March and August 2019. The participants were divided into two equal groups. Verbal structured education and written documents were given to the training group before surgery by a multidisciplinary team. The control group had the routine education. Data were collected using a Patient Information Form, the State Anxiety Inventory, a visual analog scale, and the Barthel Index for Activities of Daily Living.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
November 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elif Gezginci

RN, PhD

Saglik Bilimleri Universitesi

Eligibility Criteria

Inclusion Criteria

  • undergoing an elective laparoscopic cholecystectomy
  • no loss of sensation related to vision and hearing
  • opening to communication and cooperation
  • no cancer diagnosis
  • no chronic pain-related treatment
  • no psychological disease diagnosis
  • agreeing to participate in the study

Exclusion Criteria

  • undergoing emergency surgery
  • hospitalized in the intensive care unit
  • average score below 62 by Barthel Index

Outcomes

Primary Outcomes

The difference in pain scores measured by Visual Analog Scale between the two groups

Time Frame: The participants' pain levels were evaluated using the VAS at 06:00 AM on the first day of surgery.

This scale is a unidimensional, valid and reliable scale in the measurement of acute pain intensity. This scale, which is comprised horizontally or vertically, consists of a 10 cm scale, at one end there is "no pain", at the other end there is "worst imaginable pain," with which the patient scores their pain. As the score on the scale increases, the severity of pain intensity increases.

Secondary Outcomes

  • The difference in independence levels measured by the Barthel Daily Living Activities Index between the two groups(The independence levels of the patients in both groups were evaluated using the Barthel Daily Living Activities Index on the 10th-day follow-up appointment.)
  • The difference in anxiety scores measured by State-Trait Anxiety Inventory between the two groups(Anxiety levels were evaluated using the STAI-I just before discharge (postoperative 1st day).)

Study Sites (1)

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