- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509073
Video Education on Bariatric Surgery Fear and Recovery
The Effect of Video Education on Surgical Fear and Recovery Undergoing Bariatric Surgery
The goal of this randomised clinical study is to is to determine the effect of video education given before bariatric surgery procedure on surgical fear and recovery. The main questions it aims to answer [is/are]:
Video training reduces patients' fear of surgery. Video training improves the quality of recovery for patients.
There is a comparison group: Researchers will compare the effect of the given video training to see if it has an impact on surgical fear levels and quality of recovery.
In video group (Experiment group), patients will watch a video prepared by researchers before their surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Küçükçekmece
-
Istanbul, Küçükçekmece, Turkey (Türkiye), 16225
- Mudanya University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals who have undergone bariatric surgery,
- 18 years of age or older,
- volunteer to participate in the study.
Exclusion Criteria:
- Patients who have previously undergone bariatric surgery,
- who do not attend regular post-operative follow-up appointments,
- who cannot be contacted by phone,
- who have an American Society of Anesthesiologists (ASA) score of III or higher, and who have a psychiatric disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video education group
Video education group: In addition to routine care, patients received a researcher-developed video-based education program two days before surgery via WhatsApp or email.
The video (5-10 minutes) included information on the perioperative process, nutrition, and postoperative care, supported by visual and audio narration to enhance understanding.
Adherence was confirmed via telephone contact one day before surgery.
Baseline assessments, outcome measures, and follow-up procedures were identical to those in the control group.
|
A preoperative information video specific to bariatric surgery has been prepared.
|
|
Active Comparator: Control group
Control Arm (Routine Care): Baseline data, including sociodemographic and clinical characteristics, were collected preoperatively.
Surgical fear was assessed at 3 and 1 days prior to surgery.
All patients received routine verbal preoperative education three days before surgery, covering general information about bariatric surgery, the perioperative process, and postoperative care.
Postoperative outcomes included recovery quality (QoR-15 on postoperative days 1 and 7), pain intensity (VAS on postoperative days 1, 3, and 7), daily pain recording after analgesic administration, additional analgesic use, and satisfaction with education (postoperative day 7).
Patients received standard perioperative clinical follow-up.
|
Standart care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical fear
Time Frame: Patients completed the surgical fear scale twice: once two days before the surgery and once one day before.
|
It was used to determine the levels of fear in patients before surgery.
|
Patients completed the surgical fear scale twice: once two days before the surgery and once one day before.
|
|
Quality of recovery
Time Frame: Patients' quality of recovery was assessed twice, on day 1 and day 7 post-surgery.
|
Quality of Recovery-15 (QoR-15): This scale evaluates five areas-emotional status, physical comfort, psychological support, physical independence, and pain-to assess patients' postoperative surgical recovery.
|
Patients' quality of recovery was assessed twice, on day 1 and day 7 post-surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: Patients' pain scores were recorded by the patients themselves a total of 3 times, on days 1, 3, and 7 postoperatively, in the mornings before taking analgesics.
|
Visual analog scale: It was used to measure the postoperative pain levels of patients.
|
Patients' pain scores were recorded by the patients themselves a total of 3 times, on days 1, 3, and 7 postoperatively, in the mornings before taking analgesics.
|
Collaborators and Investigators
Publications and helpful links
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
- BursaSYTRH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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