NCT07266987

Brief Summary

This quasi-experimental study aims to determine the effect of watching an educational and therapeutic video on patients' pain, anxiety, and comfort levels during thyroid biopsy procedures. The study will be conducted in the interventional radiology unit of Muş State Hospital between July 30, 2025, and August 28, 2026. A total of 68 patients (34 experimental and 34 control) will be included. Data will be collected using the Descriptive Information Form, Visual Analog Scale for Pain (VAS-Pain), State Anxiety Inventory, and Visual Analog Scale for Comfort (VAS-Comfort). The intervention group will watch a relaxing educational video immediately before and during the biopsy procedure, while the control group will receive standard care. Pre- and post-test measurements will be compared to evaluate changes in pain, anxiety, and comfort levels

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
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

August 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 5, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

November 24, 2025

Last Update Submit

November 24, 2025

Conditions

Keywords

painpatientnursing care

Outcome Measures

Primary Outcomes (1)

  • The patient's pain level

    Visual Analog Scale for Pain (VAS-Pain): Developed by Freyd (1983) to measure pain intensity on a 10-cm scale (0 = no pain, 10 = worst pain).

    5 month

Study Arms (2)

experimental group

EXPERIMENTAL
Other: MULTİSENSORY Video

Control Group

NO INTERVENTION

Interventions

The multisensory video is a short therapeutic and relaxing video designed to stimulate multiple senses-sight and hearing-simultaneously. It includes calming nature scenes, soft background music, and soothing narration to create a relaxing environment. The purpose of the multisensory video is to reduce anxiety, distract attention from the invasive procedure, and enhance patient comfort during the thyroid biopsy.

experimental group

Eligibility Criteria

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

You may qualify if:

  • Literate individuals who can read and write
  • Aged 18 years and older
  • Scheduled to undergo a thyroid (goiter) biopsy in the interventional radiology unit
  • Voluntarily agreeing to participate in the study and providing informed consent
  • Having no psychiatric diagnosis or cognitive impairment that may affect participation

You may not qualify if:

  • Having a diagnosed psychological or psychiatric disorder that may affect response reliability (e.g., bipolar disorder, dementia, schizophrenia)
  • Having undergone a thyroid biopsy previously
  • Having visual or hearing impairments that prevent watching or understanding the video
  • Refusing to participate or withdrawing consent during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muş State Hospital

Muş, Center, 49100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data analyst was blinded to group allocation during the statistical analysis to prevent potential bias. Participant data were coded numerically, and the analyst did not have access to information identifying which participants belonged to the intervention or control group until the analysis was completed.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: In the intervention group, patients will watch a short therapeutic and relaxing video immediately before and during the thyroid biopsy procedure. The video will be projected onto the wall in the interventional radiology room. The aim is to help patients relax, reduce anxiety, and improve comfort during the procedure. The control group will receive standard care without video intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 5, 2025

Study Start

August 20, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
1 years
Access Criteria
All information will be shared once it is provided.

Locations