- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07266987
Multisensory Methods and Patient Comfort in Thyroid Biopsy
The Effect ofMultisensory Methods on Pain, Anxiety, and Comfort Levels in Patients Undergoing Thyroid Biopsy
Study Overview
Detailed Description
This study is designed as a quasi-experimental, pretest-posttest controlled intervention trial. The study will be conducted in the interventional radiology unit of Muş State Hospital, Türkiye. The target population consists of patients scheduled for thyroid (goiter) biopsy. Sample size was determined using G*Power software (version 3.1.9.7) based on a medium effect size (d = 0.5), α = 0.05, and statistical power of 0.80, resulting in a total sample of 68 participants (34 intervention and 34 control).
Participants will be assigned to groups using an alternating allocation method. Patients with even numbers will be allocated to the intervention group, and those with odd numbers to the control group. The intervention group will receive a multisensory relaxation intervention consisting of a therapeutic audiovisual (relaxing nature-based) video displayed immediately before and during the biopsy procedure. The aim of the intervention is to reduce procedural anxiety and discomfort. The control group will receive standard routine care without any additional intervention.
Eligibility criteria include being literate and free from diagnosed psychiatric disorders. Exclusion criteria include the presence of psychiatric or neurological conditions that may affect response reliability (e.g., bipolar disorder, dementia) and previous experience of thyroid biopsy.
Data will be collected using standardized instruments, including a researcher-developed demographic and clinical information form, a Visual Analog Scale for pain assessment (VAS-Pain; 0-10 scale), the State Anxiety Inventory for measuring situational anxiety, and a Visual Analog Scale for comfort (VAS-Comfort; 0-10 scale). These instruments will be used to evaluate psychological and procedural outcomes associated with the intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mesut YILMAZ, Dr.
- Phone Number: 530 220 8685
- Email: mesut.yilmaz@alparslan.edu.tr
Study Locations
-
-
Center
-
Muş, Center, Turkey (Türkiye), 49100
- Recruiting
- Mus State Hospital
-
Contact:
- Mesut YILMAZ, Dr.
- Phone Number: 530 220 8685
- Email: mesut.yilmaz@alparslan.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Literate individuals who can read and write Aged 18 years and older Scheduled to undergo thyroid (goiter) biopsy in the interventional radiology unit Voluntarily agreeing to participate in the study and providing informed consent No diagnosed psychiatric or cognitive impairment that may affect participation
Exclusion Criteria:
Presence of a diagnosed psychiatric disorder that may affect response reliability (e.g., bipolar disorder, dementia, schizophrenia) Previous history of thyroid biopsy Visual or hearing impairments that prevent viewing or understanding the intervention video Refusal to participate or withdrawal of consent at any stage of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
|
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.
|
|
No Intervention: Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The patient's pain level
Time Frame: 5 month
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- muş alpa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on MULTİSENSORY Video
-
University Hospital, Strasbourg, FranceNot yet recruiting
-
Bilecik Seyh Edebali UniversitesiNot yet recruitingPostoperative Pain | Fear | Child, Only | Multisensory Stimulation
-
Hopital La MusseRecruitingStroke | Rehabilitation | Virtual Reality | Neuropsychology | Immersion | HemineglectFrance
-
Northeastern UniversityNational Institute on Aging (NIA); University of California, RiversideCompletedCognitive ChangeUnited States
-
Royal United Hospitals Bath NHS Foundation TrustCompletedComplex Regional Pain SyndromesUnited Kingdom
-
Wake Forest University Health SciencesNeuroscience Clinical Trial and Innovation Center (NCTIC)Completed
-
Alexandria UniversityCompletedPreterm NeonatesEgypt
-
University of MinnesotaCompleted
-
Unity Health TorontoTerminatedTraumatic Brain Injury With Prolonged Loss of ConsciousnessCanada