Investigation of the Effect of Using "Curtain"

NCT06792942 | Not Yet Recruiting

• 1 other identifier: DICLE-ARDASURUCU-004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Thyroid nodules are among the common health problems in adulthood. Thyroid cancers account for approximately 1% of all malignancies in a year.The majority of cancers are diagnosed by thyroid fine needle aspiration biopsy. The most commonly diagnosed cancer type is papillary thyroid cancer and accounts for 85% of all thyroid cancers.Thyroid Ultrasonography is the most important imaging method used in the evaluation of the thyroid gland and its nodules. It enables the detection of nodules and their characteristics and plays a role in deciding which nodules should be evaluated with fine needle aspiration biopsy.Non-pharmacological treatment methods are interventions that can be used to reduce the side effects of medical, surgical or pharmacological treatments. By using medical treatment and complementary therapy together, nurses can reduce patients' anxiety, support their sleep, create a healing environment and increase their health level. As a non-pharmacological strategy, distraction can be seen as a cost-effective approach to reduce anxiety in procedures that would cause negative anxiety and increase the opportunity for ease of operation. The curtain method also typically involves the use of visually interesting curtains or partitions that can be drawn around the patient's examination area. These curtains may have calming images or vibrant patterns that can help shift the patient's focus away from the frightening procedure being performed.

Conditions

Ultrasound Therapy; Complications; Fine Needle Aspiration Biopsy; Thyroid Nodule (Diagnosis)

Keywords

The curtain; Ultrasound Therapy; Complications; Ultrasound; Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  The scale is used to assess subjectively perceived pain. It is a 10 cm (100 mm) ruler with no pain on one end and the "most severe pain" on the other. The individuals participating in the study are asked to mark the intensity of pain they are currently feeling, explaining that the number "0" on the scale means "I feel no pain" and that the intensity of pain increases as the numbers increase, and the number "10" means" I feel the most severe pain". An increase in the score obtained from the scale in the assessment indicates that the pain is increasing. Each patient will be administered two times.

  Before and after immediately after ultrasound guided fine needle aspiration biopsy procedure

Secondary Outcomes (2)

• Fear of Pain Scale-III

  Before and after immediately after ultrasound guided fine needle aspiration biopsy procedure

• Beck Anxiety Scale

  Before and after immediately after ultrasound guided fine needle aspiration biopsy procedure

Study Arms (2)

nature view curtain group

EXPERIMENTAL

During the fine needle biopsy, the patient will look at the nature view curtain on the ceiling.

Other: nature view curtain group

Control group

NO INTERVENTION

patients without of the nature view curtain

Interventions

nature view curtain group OTHER

During the fine needle biopsy, the patient will look at the nature view curtain on the ceiling.

nature view curtain group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspicion of a mass in the thyroid
• No vision problems

You may not qualify if:

• Mental health problems

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Dicle Univertsity

Diyarbakır, South East, 21100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroid Nodule; Disease

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: They do not know the experimental or control procedures that take place
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: fine needle biopsy group and control group

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 27, 2025
• Study Start: March 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

TU (1)