Video Education and Patient Comfort in Thyroid Biopsy

NCT ID: NCT07266987

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This research was designed as a quasi-experimental study with pretest and posttest measurements, based on epidemiological intervention methods. The study will take place in the interventional radiology unit of Muş State Hospital. The study population will include all patients who are admitted to the radiology unit for thyroid (goiter) biopsy. The sample size was calculated using the G\*Power 3.1.9.7 program with a medium effect size (0.5), α=0.05, and power (1-β)=0.80, resulting in a total of 68 participants-34 in the intervention group and 34 in the control group.

Inclusion criteria: being literate and not having any psychiatric disorder. Exclusion criteria: having a psychological disorder that may affect the reliability of responses (e.g., bipolar disorder, dementia) or having undergone a thyroid biopsy before.

Participants will be assigned alternately: patients with odd numbers will be in the control group, and even numbers in the experimental group. The experimental group will watch a therapeutic (relaxing) video projected on the wall immediately before and during the biopsy. The video aims to reduce anxiety and discomfort associated with the procedure. Control group patients will receive the routine procedure without any additional intervention.

Data collection tools will include:

Descriptive Information Form: Prepared by researchers to record demographic and clinical characteristics.

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).

State Anxiety Inventory: Developed by Spielberger et al. (1970), validated in Turkish by Öner and Le Compte (1998), used to assess situational anxiety.

Visual Analog Scale for Comfort (VAS-Comfort): A 10-cm visual scale to evaluate patient comfort levels during the procedure (0 = least comfort, 10 = greatest comfort).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental group

Group Type EXPERIMENTAL

MULTİSENSORY Video

Intervention Type OTHER

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.

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MULTİSENSORY Video

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Muş Alparslan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Muş State Hospital

Muş, Center, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mesut YILMAZ, Dr.

Role: CONTACT

530 220 8685

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mesut YILMAZ, Dr.

Role: primary

530 220 8685

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

muş alpa

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Audiovisual Education on Breast Cancer
NCT06898229 ACTIVE_NOT_RECRUITING NA
Effect of Teach-Back Method in Angiography
NCT06959303 ENROLLING_BY_INVITATION NA