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Gynecologic NursingNCT05845086

The Effect of Preoperative Patient Education on Early Ambulation in Gynecological Surgery

A study testing Preoperative patient education in people with Gynecologic Nursing and Surgery, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Gynecologic Nursing, Surgery, Nurse's Role
What is being tested?
Preoperative patient education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2023to 1 Aug 2024
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 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Aydın Adnan Menderes University

    Efeler, Aydın, 09010

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Multimedia-based Preoperative Patient Education Reinforced With Teach-back Method on Early Ambulation in Gynecological Surgery: a Randomized Controlled Trial

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.

Read the detailed description

Mobilization; It is defined as "standing up, walking, being able to move and walking around, especially after the operation, when the patient stands up and walks around". Postoperative mobilization is a basic human need and one of the basic principles of nursing care. In the postoperative period, with the delay of mobilization, the patient's insulin resistance increases, muscle weakness and muscle mass loss occur, problems in pulmonary functions are experienced and the risk of thromboembolism increases. On the other hand, there is a significant relationship between increasing postoperative mobilization and postoperative recovery. It has been reported that day mobilization is significantly associated with successful surgical outcome and postoperative recovery (such as early return of bowel movements, shorter initiation of oral intake, shorter hospital stay).

Early mobilization after gynecological oncology surgeries is an important component of nursing care during the surgical process and one of the basic responsibilities of the surgical nurse. Within the scope of this responsibility, nurses should comprehensively evaluate patients physiologically and psychologically in the preoperative period, follow current evidence-based practices, and plan the nursing care process based on these practices in accordance with the clinical condition of the patient. It is reported that by following evidence-based practices in the treatment and care practices of patients in the postoperative period, the postoperative recovery process will be accelerated, the complications seen will be reduced, the hospital stay will be shortened, mortality and morbidity rates will be reduced, and patient satisfaction will be increased.

In this study, a systematic review and meta-analysis study was carried out to identify evidence-based interventions used to increase early postoperative mobilization and search PubMed, EBSCO (Medline, CINAHL), Web of Science, Cochrane, ClinicalTrials.gov and Turkey national databases (Dergipark, Turkey). Clinics, Turkmedline, and the National Thesis Center, Cochrane Library and TUBITAK Ulakbim databases were used in the last 20 years (01.01.2002-31.12.2022). Systematic reviews and meta-analyses published in Turkish and English are limited to observational studies, non-randomized and randomized controlled studies. Keywords were created according to the research question. MeSH (Medical Subject Headings) was used for English keywords, and Science Words of Turkey (SWT) was used to create Turkish equivalents of English keywords. The keywords used in the search were determined as "early ambulation" OR "early mobilization". The English keywords were determined as "Gynecologic Surgery" OR "Gynecological Surgery" OR "Gynecologic Surgical Procedure" OR "Gynecological Surgical Procedures" AND "Accelerated Ambulation" OR "Early Ambulation" OR "Early Mobilization". As a result of the screening, 6 studies that met the inclusion criteria and 2 interventions that were effective in increasing postoperative mobilization after gynecological oncology surgery were identified:

  • Preoperative patient education,
  • Exercise protocols. According to these results, it was decided to test the preoperative patient education in a randomized controlled experimental phase, considering the fact that this study is a doctoral thesis, the time limitation of the study, and the feasibility of the intervention.
Being tested
Preoperative patient education
Keywords
Early ambulation, Preoperative patient education, Nursing, Gynecologic surgery, Postoperative nursing care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative patient educationBehavioural

    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.

Study groups in NCT05845086
Study groupRoleWhat they receive
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.
Receives: Behavioral: Preoperative patient education
Control group (Usual care)No interventionThe control group continued to receive the usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Postoperative day 1

  2. 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).

    Measured: Postoperative day 2

  3. 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).

    Measured: Postoperative day 3

  4. 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.

    Measured: Postoperative day 1.

  5. 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).

    Measured: Postoperative day 2

  6. 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).

    Measured: Postoperative day 3 just as postoperative day 1.

  7. 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.

    Measured: Postoperative day 3

  8. 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).

    Measured: Postoperative day 15

  9. 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.

    Measured: Postoperative third day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start1 Aug 2023
  3. Primary completion1 May 2024
  4. Study completion1 Aug 2024

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05845086
Sponsor's protocol ID
Postoperative ambulation
Status last verified
Feb 2025
First submitted
12 Apr 2023
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Publications

  • 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.

    PubMed 40442058

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative patient education in people with Gynecologic Nursing and Surgery, run by Aydin Adnan Menderes 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 9 inclusion and 14 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 11 Feb 2025. 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?

Patient mobility level (time frame: Postoperative day 1). The study lists 9 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 NCT05845086, 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 11 Feb 2025.

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