Structured Education and Multidisciplinary Team

April 18, 2021 updated by: Elif Gezginci, Saglik Bilimleri Universitesi

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Sağlık Bilimleri Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Education Group
The patients in the training group were given structured training by a multidisciplinary team. After the content of the structured education was prepared, three experts were consulted for their opinions in terms of the scope and content. Necessary adjustments were made in line with their recommendations. Patients in this group were visited in their rooms at least 12 hours before undergoing surgery by a multidisciplinary team consisting of a surgeon, an anesthesiologist, and a nurse. The multidisciplinary team visited the patients at the same time and provided their education after introducing the team. Structured verbal education and written documents were given to the patients for 30 minutes on preoperative preparation, anesthesia, intubation, mobilization, deep breathing and coughing exercises, nutrition and fluid management, the postoperative recovery process, clinical practice guideline and operating room protocols.
Other: Education Group
The patients in the training group were given structured training by a multidisciplinary team. After the content of the structured education was prepared, three experts were consulted for their opinions in terms of the scope and content. Necessary adjustments were made in line with their recommendations. Patients in this group were visited in their rooms at least 12 hours before undergoing surgery by a multidisciplinary team consisting of a surgeon, an anesthesiologist, and a nurse. The multidisciplinary team visited the patients at the same time and provided their education after introducing the team. Structured verbal education and written documents were given to the patients for 30 minutes on preoperative preparation, anesthesia, intubation, mobilization, deep breathing and coughing exercises, nutrition and fluid management, the postoperative recovery process, clinical practice guideline and operating room protocols.
NO_INTERVENTION: Control Group
Routine education was given to the patients in the control group. Routine education was administered by a nurse working in the clinic after the patients were admitted to the hospital. The patients in this group were not trained by a multidisciplinary team. In the routine training, patients were only informed about preoperative preparation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The participants' pain levels were evaluated using the VAS at 06:00 AM on the first day of surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The difference in anxiety scores measured by State-Trait Anxiety Inventory between the two groups
Time Frame: Anxiety levels were evaluated using the STAI-I just before discharge (postoperative 1st day).
The STAI measures two types of anxiety, state anxiety and trait anxiety. State Anxiety Inventory (STAI-I) is a sensitive tool for evaluating sudden changes in emotional reactions. It requires the individual to describe how they feel at a particular moment and under certain conditions and to respond by considering their feelings about the situation they are in. The scale consists of 20 items and the responses range from 1 to 4. The total score of the scale range from 20 to 80. High scores from the scale indicate high levels of anxiety and low scores indicate low levels of anxiety.
Anxiety levels were evaluated using the STAI-I just before discharge (postoperative 1st day).
The difference in independence levels measured by the Barthel Daily Living Activities Index between the two groups
Time Frame: 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.
This index consists of 10 items (feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers (e.g. bed to chair and back), mobility on level surfaces (e.g. stairs), and questions the physical competence of the individual. Each item (unable, needs help, independent) is scored between 0-15 and 0-20 indicates total dependency; 21-61 indicates severe dependency, 62-90 indicates moderate dependency, 91-99 indicates slight dependency, and 100 indicates independence.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elif Gezginci, Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 45793301-604.01.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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