NCT07283432

Brief Summary

This research aims to determine the effect of training given via virtual reality glasses on the self-care ability of patients after bariatric surgery. This study is a single-center, parallel-group, open-label, randomized controlled clinical trial. This study will be conducted with 60 patients who underwent colorectal surgery between August 2025 and December 2025. Participants will be randomized into two groups as the intervention group (n=30) and the control group (n=30). All patients in the experimental and control groups will be asked to fill out the "Informed Consent Form" and the "Self-Care Ability Scale" by the researchers on the day before the surgery, and the patients who agree to participate in the study will be given the "Patient Introduction Form" and "Self-Care Ability Scale" by the researchers. The "Simulator Illness Questionnaire" used in the Virtual Reality disease field will be applied to the patients in the experimental group, and their physiological conditions will be determined before the application. The patients in the experimental group will be given 15-20 minutes of discharge training with virtual reality glasses before being discharged after bariatric surgery. Watching videos with virtual reality glasses will be applied by the researcher in the patient rooms and beds. The Simulator Illness Questionnaire will be repeated at the end of the application. There will be no compelling effect that will negatively affect the health of the patients during the application, and the application will be terminated when the patients feel uncomfortable. A safe environment will be created so that there are no objects around the patients that they can bump into or trip over. The virtual reality glasses will be applied after a 5-10 minute trial period with the observer at the beginning. The patient can end the study at any time. If the patients use glasses/lenses, compliance will be checked. In addition, the patients in the experimental group will be counseled for 3 months. The control group patients will not be subjected to intervention and the clinic's routine practices will continue. All patients in the experimental and control groups will be asked about their Body Mass Index via telephone interviews at 1 and 3 months after bariatric surgery and the "Self-Care Ability Scale" will be filled out.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

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

June 27, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

June 27, 2025

Last Update Submit

December 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Self-Care Abilities Scale

    The scale consists of 43 items. In our country, the scale was revised to 35 items. In the validity and reliability study of the scale, the Cronbach Alpha reliability coefficient was determined as 0.92. For the items containing statements about self-care abilities in the scale, there are the options "Does not describe me at all", "Does not describe me very much", "I have no idea", "Describes me a little" and "Describes me a lot". Each statement in the scale receives scores that can vary between zero and four. Reverse scoring is applied to the responses given to the eight items (3, 6, 9, 13, 19, 22, 26 and 31) containing negative expressions. The lowest score that can be obtained from the scale is zero, and the highest score is 140.

    preoperative day 1, postoperative 1. month and postoperative 3. month

  • Simulator Sickness Questionnaire

    The Simulation Sickness Questionnaire (SSQ) is widely used to measure Virtual Reality illness. The simulator sickness questionnaire consists of 16 questions. These questions are located under 4 components: nausea (N), oculomotor (O), disorientation (D) and weighted total (T). The majority of studies conducted using the SSQ have reported only the Total Score score.

    postoperative day 4

Study Arms (2)

Virtual reality group

EXPERIMENTAL

Patients in the experimental group will complete a "Patient Introduction Form" and a "Self-Care Ability Scale" the day before surgery. The researchers will also administer a "Simulator Illness Questionnaire" to determine their physiological status before the procedure. Before discharge from bariatric surgery, a 15-20 minute discharge training session will be provided using virtual reality headsets. The Simulator Illness Questionnaire will be repeated at the end of the procedure. The patient will be able to terminate the study at any time. Additionally, patients in the experimental group will receive counseling for 3 months. All patients in the experimental group will be asked about their Body Mass Index via telephone at 1 and 3 months after bariatric surgery and will complete the "Self-Care Ability Scale."

Device: virtual reality glasses

Control

NO INTERVENTION

All patients in the control group will be asked to fill out the "Informed Consent Form" the day before the surgery and the "Self-Care Ability Scale" will be filled out by the researchers for the patients who agreed to participate in the study. No intervention will be applied to the control group patients and the clinic's routine practices will continue. All patients in the control group will be asked about their Body Mass Index via telephone interview at 1 and 3 months after bariatric surgery and the "Self-Care Ability Scale" will be filled out.

Interventions

Patients in the experimental group will be given 15-20 minutes of discharge training using virtual reality glasses before being discharged after bariatric surgery.

Virtual reality group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are 18 years of age or older, 65 years of age or younger,
  • Who have undergone laparoscopic sleeve gastrectomy or laparoscopic gastric bypass surgery,
  • Who have not developed any complications during or after the surgical procedure,
  • Who volunteer to participate in the study will be included in the study.

You may not qualify if:

  • Patients who have not undergone laparoscopic surgery,
  • Patients with neurological or psychological problems,
  • Patients who have been transferred to the intensive care unit after surgery, - Emergency and unplanned cases,
  • Patients diagnosed with cancer,
  • Patients with visual, auditory or systemic disorders,
  • Patients with balance problems,
  • Patients diagnosed with hypertension and hypotension,
  • Patients diagnosed with anxiety disorder or epilepsy will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 27, 2025

First Posted

December 15, 2025

Study Start

August 1, 2025

Primary Completion

December 10, 2025

Study Completion

December 10, 2025

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations