The Effect of Preoperative Patient Education on Early Ambulation in Gynecological Surgery
The Effect of Multimedia-based Preoperative Patient Education Reinforced With Teach-back Method on Early Ambulation in Gynecological Surgery: a Randomized Controlled Trial
1 other identifier
interventional
112
1 country
1
Brief Summary
This study was planned as a randomized controlled study to test the effect of multimedia supported patient education reinforced with the "teach back" method in the preoperative period on postoperative mobilization in women who underwent gynecological oncology surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
1 active site
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
First Submitted
Initial submission to the registry
April 12, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedFebruary 11, 2025
February 1, 2025
9 months
April 12, 2023
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Patient mobility level
Assessed with Patient Mobility Scale. The scale is used to evaluate patient perceptions and objective observations regarding postoperative patient mobility. The scale questions are related to the severity of pain derived from the five-point likert scale, and for each item in the scale, the participants said "no pain" (1 point); "a mild pain" (2 points); "moderate pain" (3 points); They are asked to mark as "extreme pain" (4 points) and "the worst pain they can imagine" (5 points). The scores from all activities are added together to calculate the scores from the scale. The lowest score that can be obtained from the scale is 0, and the highest score is 120. A higher total score from the scale indicates increased pain and difficulty associated with activity.
Postoperative day 1
Patient mobility level
Assessed with Patient Mobility Scale just as postoperative day 1. The lowest score that can be obtained from the scale is 0, and the highest score is 120. A higher total score from the scale indicates increased pain and difficulty associated with activity. (Repeated measure).
Postoperative day 2
Patient mobility level
Assessed with Patient Mobility Scale just as postoperative day 1 and 2. The lowest score that can be obtained from the scale is 0, and the highest score is 120. A higher total score from the scale indicates increased pain and difficulty associated with activity. (Repeated measure).
Postoperative day 3
Observer mobility level
Assessed with Observer Mobility Scale. Observer Mobility Scale, During the performance of 4 activities (turning from side to side in the bed, sitting by the bed, standing up by the bed and walking in the patient room) after the surgical intervention, addiction was assessed. The state/degree of independence is scored between "1" and "5". The scores for the 4 activities are added together to calculate the scale score. The lowest and highest score that can be obtained from the scale is between 4-20. The increase in the score indicates that the mobility skills of the patients are insufficient, and the decrease in the score indicates that their ability to move after the surgical intervention is good/sufficient.
Postoperative day 1.
Observer mobility level
Assessed with Observer Mobility Scale just as postoperative day 1. The lowest and highest score that can be obtained from the scale is between 4-20. The increase in the score indicates that the mobility skills of the patients are insufficient, and the decrease in the score indicates that their ability to move after the surgical intervention is good/sufficient. (Repeated measure).
Postoperative day 2
Observer mobility level
Assessed with Observer Mobility Scale just as postoperative day 1. The lowest and highest score that can be obtained from the scale is between 4-20. The increase in the score indicates that the mobility skills of the patients are insufficient, and the decrease in the score indicates that their ability to move after the surgical intervention is good/sufficient. (Repeated measure).
Postoperative day 3 just as postoperative day 1.
The surgical recovery status after intervention
assessed with Postoperative Recovery Index Form. There are 5 sub-dimensions of the scale; psychological symptoms, physical activities, general symptoms, intestinal symptoms, and craving-desire symptoms. The scores of the items included in the sub-dimensions are summed, their arithmetic average is taken, and the sub-dimension score is determined. For the total score of scale; all 25 items are summed and the arithmetic average is taken. The total score that can be obtained from the index is reported as 25 (minimum) and 175 (maximum). The index can be applied any time between the 1st day and the 30th day after surgery. High scores from the index reflect more difficulty in post-operative recovery, while low scores indicate that recovery is easier after surgery.
Postoperative day 3
The surgical recovery status after intervention
assessed with Postoperative Recovery Index Form just as postoperative day 3. The total score that can be obtained from the index is reported as 25 (minimum) and 175 (maximum). The index can be applied any time between the 1st day and the 30th day after surgery. High scores from the index reflect more difficulty in post-operative recovery, while low scores indicate that recovery is easier after surgery. (Repeated mesure).
Postoperative day 15
Care satisfaciton
assessed with Newcastle Nursing Care Satisfaction Scale. In this study, only the scale part of the scale will be used. The 19 items in the scale are 5-point likert-type and aim to describe the satisfaction of patients in various aspects of nursing care. In the scoring used to determine the degree of satisfaction; 1- I was never satisfied, 2- I was rarely satisfied, 3- I was satisfied, 4- I was very satisfied, 5- I was completely satisfied. The scale has no cut-off point. With the scale, the satisfaction of the patient in terms of nursing is evaluated as long as the patient stays in the patient's room. Score evaluation is made over 0-100 points by converting to 100 after the scores of all items in the scale are summed. It is reported that a total score of 100 indicates satisfaction with all aspects of nursing care.
Postoperative third day
Study Arms (2)
Intervention group (Preoperative patient education)
EXPERIMENTALIn addition to the usual care provided by the nurses, the intervention group will be provided with multimedia-supported written and verbal pre-operative patient training, reinforced by the teach-back method, created according to the literature.
Control group (Usual care)
NO INTERVENTIONThe control group continued to receive the usual care
Interventions
In this study, preoperative patient education will be given, reinforced with multimedia supported written and verbal teach-back method, created according to the literature. Videos of exercises used to increase postoperative mobilization (deep breathing exercise, coughing exercise, intensive spirometer use, etc.) will be taken by the researcher in a professional studio. The captured videos will be embedded in the PowerPoint presentation and presented to the patient with a tablet computer. The powerpoit presentation should be a maximum of 30 slides and the patient education should take a maximum of 30 minutes. Patients will be evaluated face-to-face on the 1st, 2nd, 3rd days after surgery and by phone on the 15th day. The prepared powerpoint presentation will be left with the patient as a printout. The prepared video will be given to the patient after the training with a program (via WhatsApp, e-mail, bluetooh) on their phones in accordance with the preferences of the patients.
Eligibility Criteria
You may qualify if:
- Having elective surgery
- Be conscious
- Having undergone gynecological oncological (vulva-vaginal cancer, ovarian cancer, cervical cancer, fallopian tube cancer, endometrial cancer) surgery
- Absence of mental and physical problems (such as Alzheimer's disease, dementia, orthopedic problems and limb amputation) that prevent early mobilization
- Having normal blood pressure and heart rate
- Being in ASA I, II and III classification
- Absence of abnormal findings at the incision site
- Have a phone number where you can be reached
- Permission of the physician (As the physician may recommend absolute bed rest to the patient in some cases in accordance with the clinical picture of the patients, the patient will not be included in the study in the presence of such a recommendation)
You may not qualify if:
- Being diagnosed with a neurological and/or psychiatric disorder
- Having a disability related to mobility
- Those with delirium in the postoperative period
- Patients with cardiac problems
- Patients with a history of diagnosed venous thrombosis
- Have had surgery in the last 1 month those who are pregnant
- Patients with a body temperature of 38.5 and above in the perioperative period
- Don't be intubated
- Lack of knowledge that he has been diagnosed with cancer (the case that the diagnosis is hidden from the patient)
- Using an assistive device for mobility
- Physician's written bed rest instruction
- Presence of abnormal finding in the surgical field
- Presence of a pacemaker
- Presence of respiratory diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aydın Adnan Menderes University
Efeler, Aydın, 09010, Turkey (Türkiye)
Related Publications (1)
Arslan E, Ozkan S. Effects of Preoperative Mobilization Education Using the Teach-Back Method on Patient Outcomes After Gynecological Surgery: A Randomized-Controlled Study. Nurs Health Sci. 2025 Jun;27(2):e70151. doi: 10.1111/nhs.70151.
PMID: 40442058DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ezgi Arslan
Aydın Adnan Menderes University, Faculty of Nursing, Surgical Nursing Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 12, 2023
First Posted
May 6, 2023
Study Start
August 1, 2023
Primary Completion
May 1, 2024
Study Completion
August 1, 2024
Last Updated
February 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- 12 months after publication
- Access Criteria
- Relevance to the topic of the study and approval of all-authors within 1 month of receiving the request.
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.