Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06199687 |
| Other study ID # |
TUTF-GOBAEK 2022/300 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2, 2023 |
| Est. completion date |
September 13, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Trakya University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to examine the effect of virtual reality application on
pain management, comfort, and care satisfaction in patients undergoing
thyroidectomy-parathyroidectomy. The main questions it aims to answer are:
1. Does the use of virtual reality reduce the level of postoperative pain in patients
undergoing thyroid and parathyroid surgery?
2. Does the use of virtual reality increase the postoperative comfort level in patients
undergoing thyroid and parathyroid surgery?
3. Does the use of virtual reality increase the level of satisfaction after surgery in
patients undergoing thyroid and parathyroid surgery? Participants in the experimental
group watched a virtual reality video containing nature and sea images and music playing
in the background for 15 minutes. Participants in the control group received routine
clinical care after thyroidectomy and parathyroidectomy. The pain levels of the patients
in the experimental group were lower, and the comfort level was higher than in the
control group. There was no difference between the groups in terms of satisfaction level
with nursing care.
Description:
Aim:
To examine the effect of virtual reality application on pain management, comfort and care
satisfaction in patients undergoing thyroidectomy-parathyroidectomy.
Methods:
Settings and Design: This randomized controlled experimental study was conducted between
February 6 - September 13 2023 with the participation of 69 patients who underwent
thyroidectomy or parathyroidectomy in the general surgery unit of a university hospital.
The patients who underwent elective thyroidectomy or parathyroidectomy, had a postoperative
drain, received the same analgesic treatment, stood up and started to feed orally, and agreed
to watch videos with virtual reality glasses were included in the study.
Patients who have hearing problems and cannot speak Turkish and developed complications
during the pre-operative and post-operative periods, who were diagnosed with severe visual
impairment, epilepsy, and/or vertigo, and who experienced dizziness, nausea, and vomiting
during the virtual reality application, were excluded from the study.
During the follow-up period of the study, one patient was excluded from the study because she
experienced dizziness during the virtual reality application.
"Data Collection Form" was used to collect research data, "Numerical Evaluation Scale (0-10)"
was used to evaluate the criteria regarding postoperative pain and satisfaction levels with
nursing care, and "General Comfort Scale-Short Form" was used to evaluate the comfort
criterion.
In order to avoid bias when grouping the patients to be included in the study, a
randomization list was drawn up and the patients were randomly divided into 35 experimental
groups and 35 control groups according to the order of hospitalization. In the randomization
list made using the computer program, the letter "A" represented the experimental group and
the letter "B" represented the control group.
During the data collection process, 70 patients who met the research criteria were
interviewed and the patients were divided into two groups: the experimental group (35
patients) and the control group (35 patients). The randomization list was used to assign
patients to groups. The experimental group consisted of patients who received postoperative
virtual reality application, and the control group consisted of patients who received routine
postoperative care. One patient in the experimental group was excluded from the study because
he experienced dizziness during virtual reality application. The study was completed with 69
patients, 34 patients included in the experimental group and 35 patients assigned to the
control group.
All patients received standard care after thyroid and/or parathyroid surgery. The standard
care provided to the patients included nonsteroidal analgesic and antibiotic treatment
administered twice a day (10:00, 22:00), as well as treatments and care to reduce sore throat
and difficulty swallowing. In addition to receiving standard treatment and care, patients in
the experimental group were allowed to watch virtual reality videos.
Patients who met the inclusion criteria for the study were visited in their rooms the day
after the surgery (day 1 after surgery), at a time outside the clinic visit, meal, treatment
and visiting hours. The patients were informed about the research and their written and
verbal consent to participate in the study was obtained. All patients who agreed to
participate in the study were asked by the researchers about their pain levels according to
the questions in the data collection form and the numerical rating scale, and their answers
were recorded.
In the experimental group, after recording the answers of the patients to the questions in
the data collection form, a video called "Turkey 4K - Scenic Relaxation Film With Calming
Music", containing nature and sea images with music was showed for 15 minutes with virtual
reality glasses. Virtual reality glasses were disinfected after use for each patient. The
patients' pain levels were re-evaluated after the virtual reality application was completed.
Following the second pain assessment of the patients, evaluations were made regarding their
comfort and satisfaction levels.
Pain levels of the patients who were in the control group were evaluated after recording
their answers to the questions in the data collection form. After this evaluation, no
intervention was made to the patients. After 15 minutes, the patients' pain intensity was
re-evaluated and their comfort and satisfaction levels were also evaluated.
Pain evaluations of patients in both experimental and control groups were made between the
3rd and 4th hours following the last analgesic application. Patients in the experimental
group were informed in detail about the use of virtual reality glasses before pain
assessment, and their compliance with the virtual reality application was evaluated during
the intervention. In the experimental group, it was observed that all patients adapted
sufficiently to the application, except for one patient who experienced dizziness during the
application. The data collection and application processes of the study took approximately 60
minutes for each patient.
Statistical Analysis Data obtained from 69 patients were analyzed using the IBM Statistical
Package for the Social Sciences (SPSS) 22.0 (IBM, Armonk, New York, USA) package program.
Normal distribution was determined by the Kolmogorov-Smirnov test. The Independent Sample
t-Test was used to compare the pain, comfort and satisfaction scores between the two groups.
Paired Sample t-Test was used to compare the means of pain, comfort and satisfaction scores
scores within the group. The statistical significance level was accepted as p < 0.05.
