- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07708974
Video-Based Preoperative Education in Laparoscopic Tubal Ligation (VPE-LTL)
Video-Based Preoperative Education Versus Traditional Verbal Counseling for Anxiety, Pain, and Patient Satisfaction in Women Undergoing Laparoscopic Tubal Ligation: A Quasi-Experimental Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ordu
-
Ordu, Ordu, Turkey (Türkiye), 52200
- Ordu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Women who voluntarily agreed to participate in the study Women scheduled for laparoscopic tubal ligation and deemed medically eligible for surgery Women who were able to provide informed consent For participants assigned to the video-based education group, sufficient visual and auditory ability to watch and understand the educational video
Exclusion Criteria:
Women who declined to participate Women who were unable to read and understand the study materials Women with conditions that prevented reliable completion of the study assessments Women who did not complete the required assessment forms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video-Based Preoperative Education Group
Participants in this group received video-based preoperative education before laparoscopic tubal ligation.
|
Video-based preoperative education was provided to women before laparoscopic tubal ligation.
|
|
Active Comparator: Routine Preoperative Information Group
Participants in this group received routine preoperative information before laparoscopic tubal ligation.
|
Routine preoperative information was provided before laparoscopic tubal ligation as part of standard care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Postoperative Patient Satisfaction Score on a Single-Item 5-Point Likert Satisfaction Scale
Time Frame: Immediately after recovery from anesthesia on the day of surgery
|
Overall postoperative patient satisfaction was assessed using a single-item 5-point Likert satisfaction scale.
Participants selected one response ranging from 1 point ("not satisfied at all") to 5 points ("very satisfied").
The unit of measure is points.
Higher scores indicate greater patient satisfaction.
The outcome metric is the mean satisfaction score reported for each study arm
|
Immediately after recovery from anesthesia on the day of surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTL-VPE-2024-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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