NCT06914830

Brief Summary

The effect of musical video with virtual reality goggles on patient's anxiety and comfort during ureteroscopy

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

June 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 21, 2025

Last Update Submit

April 3, 2025

Conditions

Keywords

Ureteroscopymusic therapyvirtual realityanxietycomfort

Outcome Measures

Primary Outcomes (2)

  • Determination of the patient's anxiety levels after the intervention

    The Surgery-Specific Anxiety Scale is a five Likert-type scale assessing of anxiety. The reference range of the scale is 0-50, with a higher score reflecting fear of pain, fear of dying during surgery, and fear of postoperative complications and limitations. Cronbach's alpha value of the scale is 0.79.

    two hours after surgery

  • Determination of the patient's comfort levels after the intervention

    The Perianesthesia Comfort Scale is based on a theoretical framework of three levels and four dimensions. It evaluates comfort needs and the achievement of expected comfort improvements. Scale scoring is 24-144 (min-max). Cronbach's alpha: 0.83. A low score indicates poor comfort and a high score indicates good comfort.

    two hours after surgery

Study Arms (2)

Experimental group

EXPERIMENTAL

The study group was shown the musical video created by the researchers by taking expert opinions during the surgery.

Other: Musical video demonstration with virtual reality glasses

Control group

NO INTERVENTION

The control group continued to receive the routine care

Interventions

The research was explained to the patient before the operation. The patient was started to watch a video with music with virtual glasses at the 5th minute of the operation and watched it throughout the operation. Two hours after the surgery, the patient who underwent ureteroscopy completed the Data Collection Form, Surgery Specific Anxiety Scale and Perianesthesia Comfort Scale.

Experimental group

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being able to speak and understand Turkish
  • Being open to communication
  • Being literate
  • Being over 18 years of age
  • Having a Glasgow Coma Scale score of 13 and above

You may not qualify if:

  • Visual and hearing impairment
  • Previous surgery
  • Being a healthcare personnel
  • General anesthesia of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Efeler, Aydın, 09090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Hilal Hatice ÜLKÜ, PhD

    Aydin Adnan Menderes University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Following recruitment, patients were divided into study and control groups by randomization (1:1 randomization)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

March 21, 2025

First Posted

April 6, 2025

Study Start

June 10, 2024

Primary Completion

December 10, 2024

Study Completion

May 10, 2025

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

Shared Documents
CSR
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations