Anxiety Levels Before Hemodialysis Catheter Insertion

Anxiety Levels Clinical Trial

Official title:

Determination of Anxiety Levels After Verbal and Video Informing of Hemodialysis Patients Before Hemodialysis Catheter Insertion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03951129
• Other study ID #: 587943
• Status: Recruiting
• Start date: November 27, 2018
• Est. completion date: August 27, 2019

Study information

• Verified date: May 2019
• Source: Aksaray University Training and Research Hospital
• Contact: Hüseyin Mutlu, MD
• Phone: +905053493263
• Email: hmutlu70[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Determination of anxiety levels after verbal and video informing before hemodialysis catheter insertion

Description:

Treatment options for end-stage renal patients are renal transplantation, peritoneal dialysis, or hemodialysis, and the majority of these patients live on hemodialysis dependent. The venous access route required for hemodialysis is provided by dialysis catheters until arterio-venous shunts are performed. The aim of this study was to determine the difference between verbal or video-related anxiety levels of patients with hemodialysis and determine which one is better before the hemodialysis procedure is performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: August 27, 2019
• Est. primary completion date: June 27, 2019
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18 -65

• Agree to participate in the study

• No need for emergency hemodialysis

• No previously known psychiatric disorder

• No history of hemodialysis before

• No history of surgical procedures

Exclusion Criteria:

• Refusing to participate in the study

• <18 years of age and >65 years

• Need emergency dialysis

• The presence of previously known psychiatric disorder

• Presence of dialysis and catheter

• Presence of a history of surgical procedure

• Lack of information and documents

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Levels

Intervention

Procedure:
• hemodialysis catheter insertion
The State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) scoring will be performed after informing all groups and after the procedure

Locations

Country	Name	City	State
Turkey	Aksaray Universty	Aksaray

Sponsors (1)

Lead Sponsor	Collaborator
Aksaray University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) levels	The State-Trait Anxiety Inventory (STAI):To measure via self-report the presence and severity of current symptoms of anxiety and a generalized propensity to be anxious. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale Visual Analogue Scale (VAS): The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Using a ruler, the score is determined by mea-surging the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)	10 minute