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Structured Education and Multidisciplinary Team

Primary Purpose

Pain, Anxiety, Activities of Daily Living

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education Group
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain focused on measuring anxiety, cholecystectomy, education, multidisciplinary team, pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saglık Bilimleri Universitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

The difference in anxiety scores measured by State-Trait Anxiety Inventory between the two groups
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.
The difference in independence levels measured by the Barthel Daily Living Activities Index between the two groups
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.

Full Information

First Posted
April 18, 2021
Last Updated
April 18, 2021
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT04850586
Brief Title
Structured Education and Multidisciplinary Team
Official Title
The Impact of Structured Education Given by a Multidisciplinary Team on Pain, Anxiety, and Activities of Daily Living in Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 29, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Activities of Daily Living
Keywords
anxiety, cholecystectomy, education, multidisciplinary team, pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Education Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The difference in pain scores measured by Visual Analog Scale between the two groups
Description
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.
Time Frame
The participants' pain levels were evaluated using the VAS at 06:00 AM on the first day of surgery.
Secondary Outcome Measure Information:
Title
The difference in anxiety scores measured by State-Trait Anxiety Inventory between the two groups
Description
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.
Time Frame
Anxiety levels were evaluated using the STAI-I just before discharge (postoperative 1st day).
Title
The difference in independence levels measured by the Barthel Daily Living Activities Index between the two groups
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Gezginci
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saglık Bilimleri Universitesi
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28938978
Citation
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Results Reference
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31280554
Citation
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Results Reference
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PubMed Identifier
29153299
Citation
Lee CH, Liu JT, Lin SC, Hsu TY, Lin CY, Lin LY. Effects of Educational Intervention on State Anxiety and Pain in People Undergoing Spinal Surgery: A Randomized Controlled Trial. Pain Manag Nurs. 2018 Apr;19(2):163-171. doi: 10.1016/j.pmn.2017.08.004. Epub 2017 Nov 15.
Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Results Reference
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Structured Education and Multidisciplinary Team

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