NCT05251857

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

December 29, 2021

Last Update Submit

May 4, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    until the treatment is completed,an average of 5 days

Secondary Outcomes (1)

  • Respiratory complications question form

    until the treatment is completed,an average of 5 days

Study Arms (2)

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

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

Interventions

Behavioral: Animation Education Program The investigators will apply Animation Education Program.

Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25070, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professors

Study Record Dates

First Submitted

December 29, 2021

First Posted

February 23, 2022

Study Start

February 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 15, 2021

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations