NCT05845086

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

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

April 12, 2023

Last Update Submit

February 7, 2025

Conditions

Keywords

Early ambulationPreoperative patient educationNursingGynecologic surgeryPostoperative nursing care

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)

EXPERIMENTAL

In 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.

Behavioral: Preoperative patient education

Control group (Usual care)

NO INTERVENTION

The 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.

Intervention group (Preoperative patient education)

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

Study Officials

  • Ezgi Arslan

    Aydın Adnan Menderes University, Faculty of Nursing, Surgical Nursing Department

    PRINCIPAL INVESTIGATOR

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

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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.

Locations