NCT06199687

Brief 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. 1.Does the use of virtual reality reduce the level of postoperative pain in patients undergoing thyroid and parathyroid surgery?
  2. 2.Does the use of virtual reality increase the postoperative comfort level in patients undergoing thyroid and parathyroid surgery?
  3. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

December 28, 2023

Last Update Submit

December 28, 2023

Conditions

Keywords

Postoperative painNursing carePatient ComfortPatient satisfactionVirtual reality

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain after virtual reality

    Assessment of pain after watching a virtual reality video by using numerical pain scale (0-10)

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

Secondary Outcomes (2)

  • Patient comfort

    Within 30 minutes after the virtual reality video ends

  • Patients satisfaction with nursing care

    Within 30 minutes after the virtual reality video ends

Study Arms (2)

Experimental group

EXPERIMENTAL

The 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.

Other: Use of Virtual Reality

Control Group

NO INTERVENTION

Patients received standard care.

Interventions

Use of Virtual Reality after After Thyroid-Parathyroid Surgery

Experimental group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University Health Science Faculty

Edirne, 22020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePatient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sacide Yildizeli Topcu, PhD

    Trakya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Experimental - Randomised Controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 10, 2024

Study Start

February 2, 2023

Primary Completion

September 13, 2023

Study Completion

September 13, 2023

Last Updated

January 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available.

Locations