SurgeryNCT05251857
Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients
A study testing Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients in people with Surgery and Educational Problems, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Educational Problems
- What is being tested?
- Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Surgery, Educational Problems
- Being tested
- Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy PatientsBehavioural
Behavioral: Animation Education Program The investigators will apply Animation Education Program.
| Study group | Role | What they receive |
|---|---|---|
| Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients | Experimental | The intervention group is the group in which the investigors applied animation education program Intervention: Behavioral: Animation Education Program Receives: Behavioral: Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients |
| Standard Clinical Care Applied to Laparoscopic Sleeve Gastrectomy Patients | No intervention | The control group is the group that receives standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
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
Measured: until the treatment is completed,an average of 5 days
Richard Campbell Sleep Questionnaire (RCSQ)
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.
Measured: until the treatment is completed,an average of 5 days
Secondary outcomes (1)
Respiratory complications question form
respiratory complications
Measured: until the treatment is completed,an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Feb 2020
- Primary completion1 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Yayla, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251857
- Sponsor's protocol ID
- AEP16
- Status last verified
- May 2022
- First submitted
- 29 Dec 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yayla A, Menevse S. Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients Effect on Patient Care Results: A Randomized Controlled Trial. Clin Nurs Res. 2023 Jan;32(1):126-137. doi: 10.1177/10547738221112754. Epub 2022 Aug 23.
PubMed 36000187
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients Effect on Patient Care Results: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05251857
- Acronym / sponsor ID
- AEP16
- Conditions
- Surgery, Educational Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients | Experimental | Behavioral: Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy PatientsThe intervention group is the group in which the investigors applied animation education program Intervention: Behavioral: Animation Education Program |
| Standard Clinical Care Applied to Laparoscopic Sleeve Gastrectomy Patients | No intervention | –The control group is the group that receives standard clinical care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy PatientsBehavioral: Animation Education Program The investigators will apply Animation Education Program. | Behavioural | Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients |
Primary outcome
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
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.
1 secondary outcome
Respiratory complications question form
Time frame: until the treatment is completed,an average of 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Derived from this study: PubMed 36000187Yayla A, Menevse S. Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients Effect on Patient Care Results: A Randomized Controlled Trial. Clin Nurs Res. 2023 Jan;32(1):126-137. doi: 10.1177/10547738221112754. Epub 2022 Aug 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients in people with Surgery and Educational Problems, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: until the treatment is completed,an average of 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.