- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251857
Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients
Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients Effect on Patient Care Results: A Randomized Controlled Trial
Objectives This study investigated the effect of animation education developed for respiratory rehabilitation among sleeve gastrectomy patients on patient care results.
Design This is a randomized controlled study. Method A total of 66 patients who were going to have sleeve gastrectomy were randomly divided into two groups each including 33 participants. The intervention group was provided with animation education. The control group received routine face-to-face education. Postoperative risk of respiratory complications, presence of dyspnea, nausea, and vomiting, frequency of postoperative respiratory exercises, and satisfaction with postoperative respiratory education were examined. Patients' pain and sleep quality were examined one day before the surgery and on the postoperative first and fifth days.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey, 25070
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The patients,
who are in clinical treatment for sleeve gastrectomy; who are 18 years of age or older, mentally healthy; who can speak and understand Turkish; who owns and can use smartphones; who do not have chronic diseases related to the respiratory system (lung diseases, etc.); who are volunteers, will be included in the study.
Exclusion Criteria:
The Patients
who are a lung infection in the last month who are neurological disease who are major psychiatric diagnosis who are vision and hearing problems who are intolerable dyspnea who do not agree to participate in the study, will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients
The intervention group is the group in which the investigors applied animation education program Intervention: Behavioral: Animation Education Program
|
Behavioral: Animation Education Program The investigators will apply Animation Education Program.
|
|
No Intervention: Standard Clinical Care Applied to Laparoscopic Sleeve Gastrectomy Patients
The control group is the group that receives standard clinical care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: until the treatment is completed,an average of 5 days
|
Pain levels Visual Analog Scale (VAS): The VAS was used to evaluate the severity of pain in patients.
VAS is a 10 cm ruler that shows no pain on one edge and unbearable pain on the other edge.
Therefore, patients are asked to evaluate their pain between 0 "no pain" and 10 "unbearable pain."
They show the severity of their pain using a sign on that ruler.
The point indicated by the patient is recorded from the starting point of 0. VAS is an understandable and easily applicable scale to evaluate the pain levels of patients
|
until the treatment is completed,an average of 5 days
|
|
Richard Campbell Sleep Questionnaire (RCSQ)
Time Frame: until the treatment is completed,an average of 5 days
|
Sleep quality Richard Campbell Sleep Questionnaire (RCSQ) The scale was developed by Richards in 1987.
Its Turkish validity and reliability study was conducted by Özlü and Özer in 2015.
RCSQ evaluates the depth of night sleep, time to fall asleep, frequency of awakening, time awake when awakened, sleep quality, and the noise level in the environment.
The scale consists of 6 questions.
Each item is scored between 0 and 100 using the VAS.
A score of 0-25 points obtained from the scale indicates very bad sleep and 76-100 indicates very good sleep.
|
until the treatment is completed,an average of 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory complications question form
Time Frame: until the treatment is completed,an average of 5 days
|
respiratory complications
|
until the treatment is completed,an average of 5 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AEP16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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