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Pain, PostoperativeNCT06199687

Effect of Virtual Reality on Pain, Comfort and Satisfaction

A study testing Use of Virtual Reality in people with Pain, Postoperative and Patient Comfort, run by Trakya 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

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. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
Use of Virtual Reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Feb 2023to 13 Sep 2023
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Underwent elective thyroidectomy or parathyroidectomy,
  • Had a postoperative drain,
  • Received the same analgesic treatment,
  • Stood up and started to feed orally,
  • Agreed to watch videos with virtual reality glasses

Who cannot join

  • Have hearing problems
  • Can not speak Turkish
  • Developed complications during the surgical process,
  • Diagnosed with severe visual impairment, epilepsy, and/or vertigo,
  • Experienced dizziness, nausea, and vomiting during the virtual reality application

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Trakya University Health Science Faculty

    Edirne, 22020

Other trials in Turkey (Türkiye)

About this study

Official title: Use of Virtual Reality in Providing Pain Management, Comfort and Satisfaction After Thyroid-Parathyroid Surgery

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.
Read the detailed 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.

Being tested
Use of Virtual Reality
Keywords
Postoperative pain, Nursing care, Patient Comfort, Patient satisfaction, Virtual reality
Medical subject headings
Pain, Postoperative, Patient Satisfaction

What participants receive

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

  • Use of Virtual RealityOther

    Use of Virtual Reality after After Thyroid-Parathyroid Surgery

Study groups in NCT06199687
Study groupRoleWhat they receive
Experimental groupExperimentalThe patients in the experimental group were shown a virtual reality video called 'Turkey 4K - Scenic Relaxation Film With Calming Music', containing images of nature and sea with music, for 15 minutes using virtual reality glasses.
Receives: Other: Use of Virtual Reality
Control GroupNo interventionPatients received standard care.

What is being measured

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

  1. Postoperative pain after virtual reality

    Assessment of pain after watching a virtual reality video by using numerical pain scale (0: no pain - 10: worst pain).

    Measured: Change in postoperative pain at the 15th minute after the virtual reality video ends

Secondary outcomes (2)
  1. Patient comfort

    Assessment of postoperative patient comfort after watching a virtual reality video (1: lowest comfort level - 6: highest comfort level).

    Measured: Within 30 minutes after the virtual reality video ends

  2. Patients satisfaction with nursing care

    Assessment of patient satisfaction after watching a virtual reality video by using numerical pain scale (0: completely dissatisfied - 10: highest level of satisfaction)

    Measured: Within 30 minutes after the virtual reality video ends

Timeline

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

  1. First posted10 Jan 2024
  2. Study start2 Feb 2023
  3. Primary completion13 Sep 2023
  4. Study completion13 Sep 2023

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental - Randomised Controlled
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06199687
Sponsor's protocol ID
TUTF-GOBAEK 2022/300
Status last verified
Nov 2026
First submitted
28 Dec 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data (IPD) available.

Questions about this trial

What is this clinical trial studying?

A study testing Use of Virtual Reality in people with Pain, Postoperative and Patient Comfort, run by Trakya 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 5 inclusion and 5 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 5 Nov 2026. 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?

Postoperative pain after virtual reality (time frame: Change in postoperative pain at the 15th minute after the virtual reality video ends). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Nov 2026.

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